This humble website has been created to inform the public that not all medicines are safe.
MHRA UK Gov Safety Update: Warfarin: reports of calciphylaxis
Calciphylaxis is a very rare but serious condition causing vascular calcification and skin necrosis.
Warfarin is an oral anticoagulant. It is a vitamin K antagonist that acts by inhibiting the formation of active clotting factors II, VII, IX, and X.
Risk of calciphylaxis. Calciphylaxis is a very rare but serious condition that causes vascular calcification and cutaneous necrosis. The mortality rate is high. It is also known as calcific uremic arteriolopathy.
The condition is most commonly observed in patients with end-stage renal disease on dialysis, or in those with known risk factors such as: protein C or S deficiency; hyperphosphataemia; hypercalcaemia; or hypoalbuminaemia.
Cases of calciphylaxis have been reported in patients taking warfarin. Pre-existing renal disease was commonly reported in cases, but some reports noted normal renal function.
MHRA UK Gov Drug Safety Update: A signal of increased lower limb amputation (primarily of the toe) in people taking canagliflozin compared with placebo in a clinical trial in high cardiovascular risk patients is currently under investigation.
Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated in adults with type 2 diabetes mellitus to improve glycaemic control when diet and exercise alone do not provide adequate glycaemic control. Canagliflozin is given as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
Canagliflozin can also be given as add-on therapy with other glucose-lowering drugs, including insulin, when these do not provide adequate glycaemic control.
The canagliflozin-containing medicines marketed in the UK areInvokana▼(canagliflozin) and Vokanamet▼ (canagliflozin and metformin).
FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.
Antidepressants Cause Abnormalities in Newborns’ Developing Brains
According to a new study antidepressants change the electrical brain activity of newborns exposed during pregnancy to Serotonin Reuptake Inhibitors (SRIs). The fact that antidepressants can cause brain abnormalities in newborns is in addition to the 18 drug regulatory warnings on antidepressants causing birth defects, including heart and lung malfunctions, pulmonary hypertension, preterm births, respiratory difficulties, seizures, feeding problems, vomiting, low blood sugar, floppiness, stiffness and shaking.
The new study, from Helsinki University Hospital’s Children’s Hospital and published last month in Cerebral Cortex, is the first to examine the effects of SRI exposure directly on the brain activity of newborns. The study authors found that the changes that occur in newborns’ brains, due to the mother’s SRI use, are, among other things, associated with less organized communication between the baby’s brain hemispheres. In other words, the antidepressants taken by mothers during pregnancy (compared to those who had not taken antidepressants) caused subtle abnormalities in the newborns’ brains.
Chronic HBV Treatment Linked to Increased Rates of Colorectal and Cervical Cancer
A potential link between long-term oral treatment with nucleos(t)ide analogues for chronic hepatitis B virus (HBV) and an increased risk of colorectal (P = .029) and cervical (P = .049) cancers was demonstrated in a presentation at The International Liver Congress.1
Selected patients with chronic HBV receive prolonged treatment with nucleos(t)ide analogues, which are used to prevent the virus from reproducing. Notably, questions have been raised about the long-term safety of such treatments.
FDA Drug Safety Communication: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death
The U.S. Food and Drug Administration (FDA) is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which are not approved uses of the drug.
We approved label changes for oral ketoconazole tablets in 2013 to reflect these serious risks and to remove the indication for treatment of skin and nail fungal infections. However, an FDA safety review found that oral ketoconazole continues to be prescribed for these types of conditions. In the 18 months ending in June 2015, skin and nail fungal infections were the only diagnoses1 cited for the use of oral ketoconazole in an office-based physician surveys database.2 Since the 2013 labeling change, one patient death has been reported to the FDA due to liver failure associated with oral ketoconazole prescribed to treat a fungal infection of the nails.
FDA Drug Safety Communication: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch
The U.S. Food and Drug Administration (FDA) is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is complete.
FDA Drug Safety Communication: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin
The U.S. Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin. These widely used products already contain warnings about this bleeding risk on their labels; however, we are continuing to receive reports of this serious safety issue. As a result, we will continue to evaluate this safety concern and plan to convene an advisory committee of external experts to provide input regarding whether additional FDA actions are needed.
OTC aspirin-antacid products are sold under various trade names, including Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever. They are also available as generic products.
FDA Drug Safety Communication: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse
The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide (see Examples of Drugs that Can Potentially Interact with Loperamide).The majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria. We continue to evaluate this safety issue and will determine if additional FDA actions are needed.
FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)
The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options. An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.
The $300-per-person, 'doc-in-a-box' dinners that put Salix on DOJ's naughty list
Need more evidence that pharma’s fancy dinners with doctors don’t automatically count as educational events? Check out the details behind Valeant Pharmaceuticals’ recent settlement with the Justice Department, over its Salix unit’s gastrointestinal drug marketing.
According to the whistleblower complaint joined by the U.S. Attorney’s Office, Salix sales staff stepped over multiple lines when entertaining physicians on behalf of a range of brands, including the irritable bowel syndrome drug Xifaxan and the constipation med Relistor.
Association of Proton Pump Inhibitors With Risk of Dementia
Proton pump inhibitors (PPIs) are widely used for the treatment of gastrointestinal diseases
The avoidance of PPI medication may prevent the development of dementia. This finding is supported by recent pharmacoepidemiological analyses on primary data and is in line with mouse models in which the use of PPIs increased the levels of β-amyloid in the brains of mice. Randomized, prospective clinical trials are needed to examine this connection in more detail.
Association Between Anticholinergic Medication Use and Cognition, Brain Metabolism, and Brain Atrophy in Cognitively Normal Older Adults
The use of AC medication was associated with increased brain atrophy and dysfunction and clinical decline. Thus, use of AC medication among older adults should likely be discouraged if alternative therapies are available.
Anticholinergic drugs are used to treat a variety of conditions:
- Gastrointestinal disorders (e.g., gastritis, diarrhea, pylorospasm, diverticulitis, ulcerative colitis, nausea, and vomiting)
- Genitourinary disorders (e.g., cystitis, urethritis, and prostatitis)
- Respiratory disorders (e.g., asthma, chronic bronchitis, and chronic obstructive pulmonary disease [COPD])
- Sinus bradycardia due to a hypersensitive vagus nerve.
- Insomnia, although usually only on a short-term basis.
- Dizziness (including vertigo [a.k.a. 'the spins'] and motion sickness-related symptoms)
Drug Makers Paid Fewer Fines For Bad Behavior in Recent Years
After a decade in which drug makers regularly paid huge fines for various fraudulent practices, there was a noticeable drop over the past two years, according to a new analysis by Public Citizen, the consumer advocacy group. Pharmaceutical companies paid approximately $2.8 billion to settle federal and state civil and criminal charges in 2014 and 2015, compared with $9.9 billion during 2012 and 2013. The most recent payments also amounted to the lowest two-year total since 2004 and 2005
Novartis today agreed to pay $25 million to settle charges of Bribery
Novartis today agreed to pay $25 million to settle charges that it violated the Foreign Corrupt Practices Act by making illegal payments to health care providers in China. In doing so, the company becomes the latest drug maker to get punished for paying bribes in order to boost sales in a foreign country.
The settlement also comes just one month after South Korean authorities raided Novartis offices in search of evidence the company bribed local doctors.
In China, Novartis employees at two different Chinese subsidiaries gave money, gifts, vacations, and entertainment, among other things, to health care professionals between 2009 and 2011, according to an administrative order filed by the US Securities and Exchange Commission.
BIRTH CONTROL PILL MAY RAISE SEIZURE RISK FOR SOME WOMEN
A new study suggests that ethinyl estradiol, the primary component of oral contraceptives, could increase seizures in women with epilepsy.
“We were inspired by an earlier study which surveyed women with epilepsy and found that those using hormonal contraceptives self-reported 4.5 times more seizures than those that did not use oral contraceptives,” says Samba Reddy, professor of neuroscience and experimental therapeutics at Texas A&M Health Science Center College of Medicine.
Findings of the new study, published in the journal Epilepsy Research, show that when epileptic animal models received ethinyl estradiol, they not only had more frequent seizures, but the seizures were more likely to be uncontrolled. “We suspected for some time that hormonal birth control increases seizure activity in women with epilepsy, but now we know what part of the contraceptive is problematic.”
Commonly Used Reflux and Ulcer Medication May Cause Serious Kidney Damage
Proton pump inhibitors should be used only when necessary and should not be taken long-term
• Patients who took proton pump inhibitors for heartburn, acid reﬂux, or ulcers had an increased risk of kidney function decline, chronic kidney disease, and kidney failure.
• The longer patients took the drugs, the greater their risk.
Proton pump inhibitors are widely used, overprescribed, and generally perceived as safe.
New research indicates that long-term use of certain medications commonly used to treat heartburn, acid reflux, and ulcers can have damaging effects on the kidneys. The findings come from a study appearing in an upcoming issue of the Journal of the American Society of Nephrology(JASN).
Older Americans taking more medications
The proportion of older Americans taking at least five medications or supplements went up in a recent study. The increase in people using multiple medications - known as polypharmacy - paralleled an increase in the number of older Americans at risk for major drug interactions, researchers found.
"That’s a concern from a public health standpoint, because it’s getting worse," said Dima Qato, the study's lead author from the University of Illinois at Chicago.
Qato and her colleagues previously reported that polypharmacy is common among older Americans. More than half were taking prescription and nonprescription medications between 2005 and 2006.
Fast-Acting Opioids Get New Boxed Warning - FDA strengthens risk labeling for drugs such as Vicodin
The boxed warning alerts prescribers to the risk of misuse, abuse, addiction, overdose, and death associated with the drugs, as well as the risk of neonatal opioid withdrawal syndrome (NOWS) if taken during pregnancy.
The new indication also reserves the drugs for pain "severe enough to require opioid treatment" that doesn't respond to other therapies.
The agency is also updating label safety information on both immediate-release (IR) and extended-release/long-acting (ER/LA) opioids about the risk of drug interactions that can lead to serotonin syndrome, as well as effects on the endocrine system, including adrenal insufficiency, and on decreased sex hormone levels.
How Big Pharma Is Cashing in on Addiction to Alcohol and Illicit Drugs
Addiction psychiatry, essentially treating drug addicts with other drugs, has become a hugely profitable industry.
Addiction treatment has become big business. If you haven't noticed it yet, investors certainly have. The U.S. Substance Abuse and Mental Health Services Administration projected the market for addiction treatment at about $35 billion for 2014
Blood Pressure Medication - Atacand (Candesartan Cilexetil) Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS - Hyperkalemia Concomitant use of ATACAND with drugs that may increase potassium levels may increase the risk of hyperkalemia [see Drug Interactions (7)]. Monitor serum potassium periodically
DRUG INTERACTIONS - Agents Increasing Serum Potassium Other drugs that affect serum potassium. Coadministration of ATACAND with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. Lithium - Increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium
GlaxoSmithKline to face class action over anti-depressant used on children
A Sydney law firm has launched a class action on behalf of people who as children and adolescents were prescribed the anti-depressant drug Paroxetine. Solicitor Tony Nikolic said hundreds of people had indicated they would join the class action, which he expects to file in the Federal Court at the end of May.
In 2004 the Therapeutic Goods Administration's Adverse Drug Reactions Advisory Committee said there was international concern about the risk of increased suicidal ideation and self-harm among children and adolescents using Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants.
A team led by the University of Adelaide's Professor Jon Jureidini re-examined the GlaxoSmithKline research last year and found there were "quite striking" rises in the suicidal thoughts experienced by those taking the drug compared with those taking a placebo.The review team found that 11 people who took the drug in 2001 experienced experienced suicidal thoughts or behaviours, compared with one person who took the placebo.
Mr Nikolic said one person joining the class action had been prescribed Paroxetine as a six-year-old, and soon began having suicidal thoughts. Mr Nikolic is calling for anyone who was, as a minor, prescribed Paroxetine - which also traded under a number of generic names including Chemmart Paroxetine, Extine, GenRx Paroxetine, Paroxetine Actavis and Terry White Chemists Paroxetine - to come forward if they experienced side effects. These side effects could include suicidal feelings, attempted suicide, and causing others an injury.
M.S. Drugs - Gilenya (fingolimod) capsules 0.5 mg - Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS - Risk of Infection, Herpes Viral Infections, Progressive Multifocal Leukoencephalopathy, Liver Injury, Basal Cell Carcinoma, Hypersensitivity Reactions
Overdose on Prescription Opioid Pain Killers
This epidemic isn't being driven by illicit drugs, but by a surge in the use of prescription opioid painkillers According to government statistics, nearly 1.9 million Americans now abuse or are dependent onlegal opioids. On the slightly positive side, after increasing steadily every year since the 1990s, deaths involving the most commonly prescribed opioid pain relievers declined slightly in 2012 and remained steady in 2013, showing some signs of progress. Unfortunately, that pause was brief as drug overdose deaths jumped significantly in the last year of the study--from 2013 to 2014. In fact, in 2014, 19,000 people fatally overdosed on prescription painkillers, which represents a 16 percent increase over 2013. Increases in opioid overdose deaths were the main factor in the increase in drug overdose deaths. The death rate from the most commonly prescribed opioid pain relievers (natural and semisynthetic opioids) increased 9%. Concomitantly, the death rate from heroin increased 26%, and the death rate from synthetic opioids, a category that includes illicitly manufactured fentanyl and synthetic opioid pain relievers other than methadone, increased 80%. Nearly every aspect of the opioid overdose death epidemic worsened in 2014.
How Too Much Medicine Can Kill You
As cardiologist Peter Wilmshurst points out in a talk he gave at the Centre for Evidence-Based Medicine last year, the drug and device industry has an ethical and legal responsibility to produce profit for their shareholders but not to sell patients and doctors the best treatment. But the real scandal, he says, is the failure of regulators and the collusion of sorts between doctors, institutions and medical journals.
According to Peter Gøtzsche, professor of research design and analysis at the University of Copenhagen, prescription drugs are the third most common cause of death after heart disease and cancer. In an analysis published in the BMJ, he estimated that every year psychiatric drugs, including anti–depressants and dementia drugs, are responsible for half-a-million deaths in those aged over 65.
Taking paracetamol while pregnant 'could harm your daughter's fertility': Study links popular painkiller to smaller ovaries and fewer eggs
Pregnant women who take common painkillers like paracetamol could unwittingly be putting the fertility of their daughters at risk, a study suggests.
Paracetamol is the most widely-used painkiller in the world - and is deemed the only painkiller that is safe for mothers-to-be But tests found when a mother took paracetamol or was prescribed the aspirin-like drug indomethacin, her female offspring had fewer eggs than those not exposed to the medicines.
Female offspring had smaller ovaries and gave birth to fewer babies Prolonged use also causes levels of the hormone testosterone to plummet Medicines appeared to have a similar effect on subsequent generations Experts advise against prolonged use of the painkiller during pregnancy.
PPIs Tied to Increased Risk for Chronic Kidney Disease
Whether drugs actually cause CKD remains uncertain
Regular use of proton pump inhibitors appears to be linked to chronic kidney disease, but additional studies are needed to determine whether the drugs actually cause kidney damage, and, if so, how, researchers said.
In a prospective, community-based study involving more than 10,000 adults followed for a median of 14 years, baseline use of a proton pump inhibitor (PPI) was independently associated with a 20% to 50% higher risk for incident chronic kidney disease (CKD).
More details emerge on fateful French drug trial
A day after news broke about a clinical research tragedy in France, more details are beginning to emerge about what happened at Biotrial, the private research company in Rennes where the phase I study took place. Meanwhile, the Portuguese pharmaceutical company that sponsored the trial, Bial, confirmed in a statement issued last night that the drug tested in the study was an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme that breaks down so-called endocannabinoids in the brain. FAAH inhibitors have been proposed as a possible treatment against chronic pain. The study was halted on Monday, and all six patients who had taken the drug were hospitalized; one is brain dead, four others have neurological symptoms of varying severity, while one is under observation but without symptoms, neurologist Gilles Edan of the University of Rennes Hospital Center said yesterday. MRI imaging has shown "deep, necrotic and hemorrhagic lesions in the brain" of the patients, Edan said.
Statins were linked to higher risk of acute idiopathic pancreatitis, especially during the first year of use, Finnish date suggested
Based on these data it is concluded that statin medication seems to affect the bile metabolisms also humans and patients who use statins have increased risk of pancreatitis. Cholecystectomy in statin-using patients is as safe as in non-users although statin users had more comorbidities than non-users. Recurrence of idiopathic pancreatitis can be prevented by laparoscopic cholecystectomy.
Chemo, Tamoxifen May Increase VTE Risk Among Patients With Breast Cancer
Women receiving chemotherapy for breast cancer have a clinical important risk for developing venous thromboemboli (VTE), while women receiving tamoxifen have an increased risk of VTE immediately following endocrine therapy,
How Doctors Helped Drive the Addiction Crisis
THERE has been an alarming and steady increase in the mortality rate of middle-aged white Americans since 1999, according to a study published last week. This increase — half a percent annually — contrasts starkly with decreasing death rates in all other age and ethnic groups and with middle-aged people in other developed countries. So what is killing middle-aged white Americans? Much of the excess death is attributable to suicide and drug and alcohol poisonings. Opioid painkillers like OxyContin prescribed by physicians contribute significantly to these drug overdoses. Thus, it seems that an opioid overdose epidemic is at the heart of this rise in white middle-age mortality. The rate of death from prescription opioids in the United States increased more than fourfold between 1999 and 2010, dwarfing the combined mortality from heroin and cocaine. In 2013 alone, opioids were involved in 37 percent of all fatal drug overdoses.
First, Do No Harm: Hospital Patients Given Anti-Heartburn Drugs Have Higher Risk of Dying, Study Finds
U-M/VA computer model suggests that common use of acid-reducing medicine to prevent stomach bleeding increases mortality from infections....The extra risk of death comes from the fact that reducing acid in the stomach can increase the risk of infections – especially pneumonia and Clostridium difficile, both of which pose a serious risk to hospitalized patients who develop them.
FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density
FDA has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased bone mineral density. To address these safety concerns, FDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.
FDA is continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empaglifozin (Jardiance, Glyxambi, Synjardy), to determine if additional label changes or studies are needed.
DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain
The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. FDA has added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors.
Could antibiotics be making your child gain weight?
A new study published in the International Journal of Obesity suggests that antibiotic use may be associated with increased weight gain in children. Researchers at Johns Hopkins reviewed the electronic health records of 142,824 children ages 3 to 18 who were treated at Pennsylvania’s Geisinger Health System from 2001 to 2012. They used data on on prior prescriptions for antibiotics and patients’ body weight and height to develop a model of how a child's body mass index or BMI changes as they age and evaluate how that trajectory is altered by antibiotic prescription. They found that by age 15, children who had been prescribed antibiotics seven or more times weighed on average 3 pounds more than those who had no history of antibiotic use.
Killer Care: How Medical Error Became America's Third Largest Cause of Death, And What Can Be Done About It
A new book lays out the very real dangers each of us faces whenever we enter a hospital.
By the end of the twentieth century, the health-care industry was avid about getting its arms around the problem of error. The news about accidents among the rich and poor, famous and obscure was alarming the public and undermining its confidence in the profession. Malpractice claims were on the rise; so were monetary payouts. Insurers, hospitals, and physicians pushed back with “tort reform” designed to award and divert litigation. Since lawsuits often arose from treatment, “quality of care” initiatives grew as a method of preventing cases. All of these issues focused researchers on two problems. First, how should medical errors be defined? Second, how many of them were there? Clearly, they were killing and maiming people, causing lawsuits, and mounting costs. So size mattered critically.
Antibiotic Use Linked to Type 2 Diabetes Diagnosis
Antibiotics may contribute to or serve as early signal of developing condition
People who developed Type 2 diabetes tended to take more antibiotics in the years leading up to the diagnosis than people who did not have the condition, according to a new study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism.
Hormone Therapy Linked To Increased Risk for GI Bleeds
Study in postmenopausal women finds link between HRT and bleeds, particularly in lower intestine
Women who take hormone replacements after menopause are about 50% more likely to experience gastrointestinal (GI) bleeding as those not on the treatment, new research shows.
The risk for bleeding appears to be concentrated in the lower GI tract and correlates with increasing duration of hormone replacement therapy (HRT), according to the study of more than 70,000 women. Experts said the findings are not surprising, given previous evidence of the association and the speculation that HRT increases the risk for thromboemboli.
New Obesity Meds: Side Effects Worth Watching
Overall, an analysis by AdverseEvents shows the new obesity meds are holding their own, safety-wise. Still, postmarketing data flag some serious cardiovascular and neuropsychiatric side effects that are worth watching, the healthcare informatics firm says. The healthcare informatics firm scoured the FDA's postmarketing safety reports and found a number of psychiatric and cardiovascular side effects--as well as other problems--for Vivus' ($VVUS) Qsymia, Eisai's Belviq and Orexigen and Takeda's Contrave. Qsymia was the most risky drug, AdverseEvents concluded, with 20 cases of angle-closure glaucoma, or increased pressure behind the eye; 17 cases of mental impairment and 11 cases of suicidal ideation. Qsymia was also linked to four cases of pneumonia and three cases of deafness.
FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes
The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on our comprehensive review of new safety information, we are requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. We will also request updates to the OTC non-aspirin NSAID Drug Facts labels.
Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.
Immunization with hepatitis B vaccine accelerates SLE-like disease in a murine model.
In conclusion, herein we report that immunization with the HBVv aggravated kidney disease in an animal model of SLE. Immunization with either HBVv or alum affected blood counts, neurocognitive functions and brain gliosis. Our data support the concept that different component of vaccines may be linked with immune and autoimmune mediated adverse events.
Chronic fatigue syndrome and fibromyalgia following immunization with the hepatitis B vaccine: another angle of the 'autoimmune (auto-inflammatory) syndrome induced by adjuvants' (ASIA).
This study suggests that in some cases CFS and FM can be temporally related to immunization, as part of ASIA syndrome. The appearance of adverse event during immunization, the presence of autoimmune susceptibility and higher titers of autoantibodies all can be suggested as risk factors. ASIA criteria were fulfilled in all patients eluding the plausible link between ASIA and CFS/FM.
Autoimmunity following hepatitis B vaccine as part of the spectrum of 'Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants' (ASIA): analysis of 93 cases.
Common clinical characteristics were observed among 93 patients diagnosed with immune-mediated conditions post-HBVv, suggesting a common denominator in these diseases. In addition, risk factors such as history of autoimmune diseases and the appearance of adverse event(s) during immunization may serve to predict the risk of post-immunization diseases. The ASIA criteria were found to be very useful among adults with post-vaccination events. The application of the ASIA criteria to pediatric populations requires further study.
Human papilloma virus (HPV) vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants.
We documented here the evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry.
Doctors Got $6.5 Billion From Drug, Device Makers in U.S.
U.S. doctors and teaching hospitals got $6.49 billion from drug and medical-device makers in 2014, according to new government data on the financial links between the companies and the people who prescribe their products.
The data released Tuesday range from the royalties paid to hospitals to help develop products to fees provided to medical experts to speak at a dinner with colleagues. The payments are listed in two broad categories: money to fund research and payments to entertain doctors or compensate them for consulting or other non-research purposes.
Medical Expulsive Therapy for Ureteral Stones: No Better Than Placebo
This trial, designed to reflect current recommendations and clinical practice, not only definitively demonstrates the ineffectiveness of medical expulsive therapy for ureteral stones but also reaffirms the essential importance of large, well-designed, randomized trials for assessing clinical interventions and formulating treatment guidelines.
Men treated with ADT more likely to experience impaired cognitive performance
Men treated with androgen deprivation therapy (ADT) for prostate cancer were more likely to demonstrate impaired cognitive performance within 6 months and for up to 12 months after initiation of ADT, a new study published online early in the Journal of Clinical Oncology has shown.
Proton pump inhibitors are associated with increased risk of heart attack
People who take proton pump inhibitors (PPIs), commonly used drugs for heartburn, have a greater risk of suffering a heart attack whether or not they have any history of cardiovascular disease, suggests a data-mining study.
Boy wins £120,000 damages for narcolepsy caused by swine flu vaccine
A 12-year-old boy has been awarded £120,000 by a court that agreed he had been left severely disabled by narcolepsy triggered by the swine flu vaccine, following a three-year battle in which the government had claimed that his illness was not serious enough to merit payment. The ruling is expected to lead to as many as 100 other families of people affected by the sleeping disorder after receiving the vaccine bringing fresh compensation claims, in a dispute where the government’s initial hostility was described by the family’s legal team as offensive.
Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke
The testosterone product labels have been updated. The revised labels clarify the approved uses of these medications and include information about a possible increased risk of heart attacks and strokes in patients taking testosterone
Examination of Antidepressant Use in Late Pregnancy and Newborn Respiratory Disorder
An analysis of approximately 3.8 million pregnancies finds that use of antidepressants late in pregnancy may be associated with an increased risk of persistent pulmonary hypertension of the newborn (PPHN), according to a study in the June 2 issue of JAMA. However, the absolute risk was small and the risk increase appears more modest than suggested in previous studies. PPHN is a rare but life-threatening condition that occurs when a newborn's circulation system doesn't adapt to breathing outside the womb.
FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood
The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.
Acetaminophen reduces both pain and pleasure, study finds
Researchers studying the commonly used pain reliever acetaminophen found it has a previously unknown side effect: It blunts positive emotions. In the study, participants who took acetaminophen reported less strong emotions when they saw both very pleasant and very disturbing photos, when compared to those who took placebos. Acetaminophen, the main ingredient in the over-the-counter pain reliever Tylenol, has been in use for more than 70 years in the United States, but this is the first time that this side effect has been documented.
FDA Drug Safety Communication: FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking
The U.S. Food and Drug Administration (FDA) is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. In addition, rare accounts of seizures in patients treated with Chantix have been reported. We have approved changes to the Chantix label to warn about these risks. Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately.
FDA Drug Safety Communication: FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate)
The U.S. Food and Drug Administration (FDA) has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. We are unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv. On the basis of all of the information reviewed, we are not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection at this time. Patients should not stop receiving treatment without first talking to their health care professionals.
New Medicaid Data Show Antipsychotic Use May Increase the Risk for Diabetes in Some Children
The Children’s Hospital of Philadelphia’s (CHOP) PolicyLab published the largest study to date documenting the significant risks to children’s health associated with prescription antipsychotics, a powerful a class of medications used to treat mental and behavioral health disorders. The results suggest that initiating antipsychotics may elevate a child’s risk not only for significant weight gain, but also for Type II diabetes by nearly 50 percent; moreover, among children who are also receiving antidepressants, the risk may double. Previous PolicyLab research showed that one in three youth receiving antidepressants in the Medicaid program were receiving an antipsychotic at the same time.
FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol)
FDA is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). We have changed the prescribing instructions and approved a Boxed Warning, FDA’s strongest type of warning, regarding these serious risks. Also added is a new Contraindication, a strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product. Health care professionals should follow the new recommendations in the drug label. Patients should immediately alert their health care professional or seek emergency care if they develop breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after Feraheme administration.
Feraheme is in a class of medicines called IV iron replacement products. It is used to treat iron-deficiency anemia―a condition in which there is a lower than normal number of oxygen-carrying red blood cells because of too little iron
Huge Prescriber of Risky Antipsychotic Drug to Plead Guilty to Taking Kickbacks
Dr. Michael Reinstein has been the subject of two ProPublica investigations. For years, even while under federal investigation, he prescribed more of the drug clozapine than any other doctor in the United States.
A former Chicago psychiatrist who was the nation's top prescriber of the most powerful and riskiest antipsychotic drug intends to plead guilty to a federal felony charge of taking kickbacks from its manufacturer in exchange for prescriptions, court records show.
Ex-FDA Chief Says J&J Knew Drug Linked to Male Breast Growth
Johnson & Johnson, which paid more than $2 billion to resolve a criminal probe over its antipsychotic drug Risperdal, knew as early as 2001 that the medication caused boys to grow breasts, a former government regulator said in the first case over the treatment set to be decided by a jury.
Officials of J&J’s Janssen unit funded a 2001 study that showed 3.8 percent of boys given Risperdal during the clinical trial developed breasts that were either “probably or very likely” caused by the drug, David Kessler, the former head of the U.S. Food and Drug Administration, testified Wednesday in state court in Philadelphia.
Dabigatran: how the drug company withheld important analyses
In an investigation by The BMJ finds that recommendations for use of new generation oral anticoagulants may be flawed because regulators did not see evidence showing that monitoring drug plasma levels could improve safety.
Dabigatran is one of a new generation of oral anticoagulants for stroke prevention in patients with non-valvular atrial fibrillation recently recommended in guidelines from the National Institute for Health and Care Excellence for England and Wales.1 Guidelines in the US, Europe, and Canada have similarly recommended these drugs, in part because they don’t require monitoring of plasma levels or anticoagulant activity and subsequent dose adjustment, unlike older treatments such as warfarin. Yet information about dabigatran disclosed through previously confidential internal company documents released during litigation in the US—which they have settled for $650m (£380m; €480m)—and as a result of an investigation by The BMJ, show that the evidence on which these guidelines were based is incomplete.
Risk of Bleeding With Dabigatran in Atrial Fibrillation
Dabigatran (Pradaxa in Australia, Canada, Europe and USA, Prazaxa in Japan) is an oral anticoagulant from the class of the direct thrombin inhibitors.
Dabigatran was consistently associated with an increased risk of major bleeding and gastrointestinal hemorrhage for all subgroups analyzed. The risk of major bleeding among dabigatran users was especially high for African Americans and patients with chronic kidney disease.
Cumulative Use of Strong Anticholinergics and Incident Dementia
Higher cumulative anticholinergic use is associated with an increased risk for dementia. Efforts to increase awareness among health care professionals and older adults about this potential medication-related risk are important to minimize anticholinergic use over time.
Note: drugs include - antihistamines sold over the counter as sleep aids, such as diphenhydramine (Benadryl, McNeil-PPC Inc), or for allergy relief, such as chlorpheniramine; oxybutynin and tolterodine for overactive bladder; and the tricyclic antidepressants, such as doxepin or amitriptyline, even when used at low doses for migraine prevention or neuropathic pain.
Vying for Market Share, Companies Heavily Promote ‘Me Too’ Drugs
For more than five decades, the blood thinner Coumadin was the only option for millions of patients at risk for life-threatening blood clots. But now, a furious battle is underway among the makers of three newer competitors for the prescription pads of doctors across the country.
The manufacturers of these drugs --Pradaxa, Xarelto and Eliquis — have been wooing physicians in part by paying for meals, promotional speeches, consulting gigs and educational gifts. In the last five months of 2013, the companies spent nearly $19.4 million on doctors and teaching hospitals, according to ProPublica's analysis of federal data released last fall.
Bosulif (bosutinib) Tablets
Bosulif is indicated for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
FDA - WARNINGS AND PRECAUTIONS - Renal Toxicity
MS Drug May Trigger Lymphopenia in Slim Women. Fingolimod also increases risk in patients with low lymphocyte count.
Underweight women taking the oral multiple sclerosis drug fingolimod (Gilenya) and patients with low baseline lymphocyte counts appear to have an increased risk for drug-induced lymphopenia and may need to be closely monitored, researchers reported.
Aripiprazole: A new risk factor for pathological gambling? A report of 8 case reports
Conclusions-Adverse drug reactions were confronted with other already published case reports. Dopamine partial agonist mechanism of aripiprazole could explain the occurrence of pathological gambling.
Reports of Pathological Gambling, Hypersexuality, and Compulsive Shopping Associated With Dopamine Receptor Agonist Drugs
Severe impulse control disorders involving pathological gambling, hypersexuality, and compulsive shopping have been reported in association with the use of dopamine receptor agonist drugs in case series and retrospective patient surveys. These agents are used to treat Parkinson disease, restless leg syndrome, and hyperprolactinemia.
FDA warns about case of rare brain infection PML with MS drug Tecfidera (dimethyl fumarate)
The U.S. Food and Drug Administration (FDA) is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate), developed a rare and serious brain infection called PML, and later died. As a result, information describing this case of PML, or progressive multifocal leukoencephalopathy, is being added to the Tecfidera drug label.
Monoket (isosorbide mononitrate) Tablets
Used to prevent angina attacks (chest pain). Isosorbide mononitrate will not treat an angina attack that has already begun.
CONTRAINDICATIONS- ...added...Do not use monoket in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use monoket in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Dilatrate SR (isosorbide dinitrate) Sustained Release Tablets
Used to prevent angina (chest pain) caused by coronary artery disease. It does not work fast enough to relieve the pain of an angina attack that has already started.
CONTRAINDICATIONS-Do not use dilatrate®-SR in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as avanafil, sildenafil, tadalafil, vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use dilatrate SR in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Mircera (methoxy polyethylene glycol-epoetin beta)
Mircera is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis and patients not on dialysis.
BOXED WARNING ... edited
WARNINGS: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS, AND TUMOR PROGRESSION OR RECURRENCE
Cymbalta (Duloxetine Hydrochloride) Capsules
Used to treat major depressive disorder, general anxiety disorder and fibromyalgia.
BOXED WARNING: Suicidal Thoughts and Behaviors
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions.
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber
Bitter Pill: The Dangerous Side Effects of Fluoridated Antibiotics
Fluoroquinolones are among the most dangerous drugs on the market and should be avoided unless your life depends on it. Despite their dangers, they're the most commonly prescribed class of antibiotics in the United States.Fluoroquinolone antibiotics are known to cause severe tendon damage and/or rupture, and permanent nerve damage in hands or feet. Other side effects include acute liver toxicity, acute kidney failure, psychiatric side effects, hearing or vision problems, and other health problems—many of which are permanent
Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions
Sold under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands.
FDA is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use.
Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events
Xolair is an injectable medicine for patients 12 years of age and older with moderate to severe persistent allergic asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.
An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, FDA has added information about these potential risks to the drug label. The review found no difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated with Xolair. However, due to limitations in the 5-year study, FDA cannot rule out a potential risk of cancer with Xolair, so this information was added to the Warnings and Precautions section of the drug label.
The are 2 other MMR Vaccine Whistleblowers
We all know about CDC whistleblower William Thompson now. On August 27, he released a statement through his lawyer, Rick Morgan, in which he admitted research fraud. Thompson confessed he and his co-authors cooked the data in a key 2004 study, thereby exonerating the MMR vaccine from any connection to autism.
But what about Stephen Krahling and Joan Wlochowski? - They’re two former Merck virologists who filed a qui tam suit against Merck, the manufacturer of the very same MMR vaccine.
Long-term use of pills for insomnia and anxiety linked to Alzheimer’s risk
New research bolsters the belief that long-term use of a prescription drug commonly used to alleviate anxiety, panic attacks and sleep problems is linked in aging patients to a higher risk of Alzheimer’s disease.
Vaccine Fraud: U.S. Mainstream Media Censors Whistleblower’s Explosive Story
Secret letter to CDC head Dr. Julie Gerberding released
The CDC whistleblower who has come forward with proof that the CDC knowingly covered up scientific evidence linking the MMR vaccine to autism has now been revealed as William W. Thompson, PhD
A Study by Focus Autism Foundation Finds: CDC Whistleblower Reveals Widespread Manipulation of Scientific Data and Top-Down Pressure on CDC Scientists to Support the Fraudulent Application of Government Policies on Vaccine Safety
A top research scientist working for the Centers for Disease Control and Prevention (CDC) played a key role in helping Dr. Brian Hooker of the Focus Autism Foundation uncover data manipulation by the CDC that obscured a higher incidence of autism in African-American boys.
Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data
Conclusions:The present study provides new epidemiologic evidence showing that African American males receiving the MMR vaccine prior to 24 months of age or 36 months of age are more likely to receive an autism diagnosis
Benicar (olmesartan medoxomil) Tablets: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Benicar (olmesartan) is an angiotensin II receptor antagonist. Olmesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow. Benicar is used to treat high blood pressure (hypertension) in adults and children who are at least 6 years old. It is sometimes given together with other blood pressure medications.DRUG INTERACTIONS - Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Benicar. Monitor serum lithium levels during concomitant use.
ADVERSE REACTIONS - Post-Marketing Experience - Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive
FDA - Sporanox (itraconazole) Oral Solution - Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Sporanox (itraconazole) is an antifungal medication. Sporanox is used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails.
BOXED WARNING Congestive Heart Failure, Cardiac Effects and Drug Interactions
If signs or symptoms of congestive heart failure occur during administration of Sporanox (itraconazole) Oral Solution, continued Sporanox use should be reassessed.
FDA - Sporanox (Itraconazole) Capsules - Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Sporanox (itraconazole) is an antifungal medication. Sporanox is used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails. Coadministration with listed drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.
The association of diabetes and anti-diabetic medications with clinical outcomes in multiple myeloma
Diabetes Mellitis, Steroid Induced Diabetes in particular, is associated with poor clinical outcomes in Multiple Myeloma. Insulin/analogues are associated with poor outcomes, whereas metformin is associated with improved outcomes. No conclusion about causal relationships can be made at this time. Managing hyperglycaemia with non-insulin regimens should be investigated in randomised trials.
Outcomes For Older Adults With Pneumonia Who Receive Treatment Including Azithromycin
In a study that included nearly 65,000 older patients hospitalized with pneumonia, treatment that included azithromycin compared with other antibiotics was associated with a significantly lower risk of death and a slightly increased risk of heart attack, according to a study in the June 4 issue of JAMA.
Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication
Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and non-small-cell lung cancer.
FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. FDA is revising the labels of all docetaxel drug products to warn about this risk.
Lidocaine Viscous: Drug Safety communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain
FDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death....When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.
Soriatane (acitretin) Capsules
Soriatane is an oral retinoid, which is a synthetic form of vitamin A. Acitretin is the only oral retinoid approved by the FDA specifically for treating psoriasis.
Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
CONTRAINDICATIONS- angioedema, urticarial hypersensitivity
WARNINGS - added Capillary Leak Syndrome, Exfoliative Dermatitis/Erythroderma
ADVERSE REACTIONS - Added Immune System Disorders, Madarosis and exfoliative dermatitis, and Vascular Disorders
CONTRAINDICTIONS AND WARNINGS:
Pregnancy SORIATANE must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. SORIATANE also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Acitretin is a metabolite of etretinate (TEGISON®), and major human fetal abnormalities have been reported with the administration of acitretin and etretinate
Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin hydrochloride), Avandaryl (rosiglitazone maleate/glimepiride) Tablets
AVANDIA is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research
WARNING: CONGESTIVE HEART FAILURE
●Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (5.1). After initiation of AVANDIA, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of AVANDIA must be considered.
●AVANDIA is not recommended in patients with symptomatic heart failure. Initiation of AVANDIA in patients with established NYHA Class III or IV heart failure is contraindicated.
Risk of febrile seizures after first dose of measles–mumps–rubella–varicella vaccine: a population-based cohort study
Combining MMR and varicella into a single vaccine decreases pain for children and distress for parents, thus addressing common barriers to vaccine uptake, and may improve vaccine cover-age levels and decrease immunization delivery costs. These potential benefits must be balanced by the increased risk (albeit small) of febrile seizures with the combination vaccine. Febrile seizures are typically self-limiting and rarely have long-term effects, but they can be extremely distressing for parents, may precipitate acute care visits and may undermine confidence in immunization programs. It is a matter for debate whether the choice of separate versus combination vaccine is a policy decision or a choice for parent sto make in consultation with their vaccination provider.
MHRA - New restricted indication and monitoring recommendations for the use of Protelos (strontium ranelate)
Protelos a medicine which is used in treating osteoporosis in women after the menopause and treating osteoporosis in men.
The use of Protelos is now restricted to the treatment of severe osteoporosis: in postmenopausal women, in adult men, at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance. In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures. The current cardiovascular contraindications remain in place. Patients with established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease or uncontrolled hypertension should not be treated with Protelos.
MHRA - Domperidone: risk of cardiac side effects - restricted indication, new contraindications, and reduced dose and duration of use
Nausea + Vomiting Medication - Domperidone (Motilium).
Domperidone is associated with a small increased risk of serious cardiac side effects. Its use is now restricted to the relief of symptoms of nausea and vomiting and the dosage and duration of use have been reduced. Domperidone is now contraindicated in those with underlying cardiac conditions and other risk factors
Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin
The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.
Eszopiclone Containing Sleep Aids: Drug Safety Communication - Can Cause Next-Day Impairment
Including Lunesta and generics
FDA has notified health professionals and their medical care organizations of a new warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness.
Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems
Including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone
FDA is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use.
Toddlers Dosed With Speed? How Big Pharma Hooks America's Kids on Dangerous Meds Children with ADHD are easy targets because they will be lifelong patients and repeat customers.
A report from the Centers for Disease Control and Prevention last week confirmed what many have suspected: more than 10,000 2- and 3-year-olds in the U.S. are being dosed with drugs like Ritalin and Adderall for "attention deficit hyperactivity disorder." You read that right.
UK doctors paid $64 million by drug companies in 2013
Doctors in Britain were paid 38.5 million pounds ($64 million) by drugmakers last year, slightly less than 2012, according to new data underscoring the links between the pharmaceutical industry and prescribers.
Industry payments to doctors have come under increased scrutiny following a number of scandals over sales practices, notably in the United States, and concerns that such ties could put commercial interests ahead of the best outcome for patients.
The figure, announced by the Association of the British Pharmaceutical Industry (ABPI) on Thursday, was slightly down on the 2012 level of 40 million pounds.
Tamiflu: Millions wasted on flu drug, claims major report
Hundreds of millions of pounds may have been wasted on a drug for flu that works no better than paracetamol, a landmark analysis has said. The UK has spent £473m on Tamiflu, which is stockpiled by governments globally to prepare for flu pandemics. The Cochrane Collaboration claimed the drug did not prevent the spread of flu or reduce dangerous complications, and only slightly helped symptoms.
Heart risks of glucose-lowering drugs being overlooked in clinical trials
Why is heart failure not more rigorously assessed in clinical trials of antidiabetes drugs? In a Personal View, published in The Lancet Diabetes & Endocrinology journal, Professor John McMurray of The University of Glasgow and colleagues review evidence that hospitalization for heart failure is one of the most common and prognostically important complications of diabetes. Moreover, increasing evidence shows that some glucose-lowering drugs increase the risk of heart failure. Yet, heart failure is rarely considered as a key outcome, or even part of composite cardiovascular outcomes, in clinical trials of glucose-lowering drugs.
Drugmaker Roche must pay more than $1.5 million in damages to a woman who developed bowel disease after using the company’s Accutane acne medicine, a jury ruled in her retrial.
Officials of Basel, Switzerland-based Roche failed to properly warn Kamie Kendall’s doctors that Accutane could cause ulcerative colitis and were liable for her injuries, jurors in state court in New Jersey concluded.
It was the second trial of Kendall’s Accutane claims. A New Jersey appeals court overturned a $10.5 million verdict in 2010, ruling that a judge improperly barred Roche from using evidence about the medication’s use. Roche has lost 10 of 13 suits brought by former Accutane users that have gone to trial since April 2007, according to data compiled by Bloomberg. “This is another in a long line of juries that have found Roche knew this drug caused bowel disease and wrongfully withheld that information from patients and their doctors,” Mike Hook, Kendall’s lawyer, said in a phone interview.
FDA probes cognitive impact of new cholesterol drugs
The Food and Drug Administration has asked Regeneron Pharmaceuticals Inc and Sanofi SA to assess potential neurocognitive side effects of their experimental cholesterol drug, Sanofi said in its annual report on Friday.
Amgen Inc, which is developing a similar drug, said it has also been in communication with the agency.
The FDA said it could not discuss specific development programs, but is "aware of concerns raised with neurocognitive adverse events and other lipid-lowering therapies, including statins, and as part of our oversight of new drug development, we are carefully monitoring these events."The new drugs are part of an experimental class known as PCSK9 inhibitors designed to block a protein that maintains "bad" LDL cholesterol in the bloodstream.
Brain-Damaged UK Victims of Swine Flu Vaccine to Get £60 Million Compensation
Patients who suffered brain damage as a result of taking a swine flu vaccine are to receive multi-million-pound payouts from the UK government. The government is expected to receive a bill of approximately £60 million, with each of the 60 victims expected to receive about £1 million each.
FDA - Boxed Warning - Hyzaar (losartan potassium hydrochlorothiazide) 50-12.5 mg, 100-12.5 mg, and 100-25 mg Tablets
Warning: fetal toxicity.When pregnancy is detected, discontinue Hyzaar as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Hyzaar is used to treat high blood pressure. It is also used to decrease the risk of stroke in certain patients with high blood pressure. It may also be used for other conditions as determined by your doctor.
Losartan/hydrochlorothiazide is a combination angiotensin II receptor blocker and diuretic. The angiotensin II receptor blocker works by relaxing the blood vessels. Exactly how the diuretic works to decrease blood pressure is unknown, but it helps the kidneys to eliminate fluid and sodium from the body.
FDA - Boxed Warning Cozaar (losartan potassium) 25 mg, 50 mg, and 100 mg Tablets
Warning: fetal toxicity. When pregnancy is detected, discontinue COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Losartan is used to treat high blood pressure (hypertension) and to help protect the kidneys from damage due to diabetes. It is also used to lower the risk of strokes in patients with high blood pressure and an enlarged heart.
FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR)
The U.S. Food and Drug Administration (FDA) has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure. Our request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment.
Nonsteroidal Anti-inflammatory Drugs and Risk of Atrial Fibrillation: Is There a Relationship? Evidence from these studies suggest that AF is an additional cardiovascular risk associated with NSAIDs,2,5 with the strongest association evident for new users and individuals who take NSAIDs for longer periods of time. These findings have clinically significant implications due to the high rate of administration of NSAIDs to treat pain and inflammation associated with a wide variety of musculoskeletal and other conditions. This is particularly important for older adults, who are at increased risk of AF by virtue of their advanced age. Of greatest concern, of course, are older patients who have been diagnosed with hypertension or heart failure and are already at increased risk for the adverse effects of NSAIDs because of these conditions
Dr. House Helps Diagnose Heart Failure From Hip Implants
A case of heart failure caused by cobalt intoxication from an artificial hip was solved with the aid of the U.S. television show “House,” according to a report published in a medical journal today. The case study shows the wide-ranging health impact from certain metal hip implants. They can expose patients to high levels of toxic cobalt and chromium ions that can seep into tissues and destroy muscle and bone, leaving some with long-term disability, the British Medical Journal has said. Studies also show that metal ions can seep into the bloodstream, spreading to the lymph nodes, spleen, liver and kidneys, according to the journal.
Merck Said to Agree to $100 Million NuvaRing Settlement
Merck & Co. (MRK) agreed to pay $100 million to settle several thousand lawsuits alleging the drugmaker’s NuvaRing contraceptive device causes potentially fatal blood clots. The settlement, which resolves cases in federal and state courts in Missouri and New Jersey, will provide an average payout of more than $58,000 a case and will be announced today, said the people, who asked not to be identified because they weren’t authorized to speak publicly about it.
FDA warns of possible harm from exceeding recommended dose of over-the-counter sodium phosphate products to treat constipation
On January 8, 2014, FDA is warning the public that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death. OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally.
FDA Safety Alert - Testosterone Products + Risk - Stroke, Heart Attack + Death
FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.
FDA Update - Avastin (bevacizumab) - Arterial Thromboembolic Events
Avastin is a vascular endothelial growth factor specific angiogenesis inhibitor indicated for the treatment of : Metastatic colorectal cancer, with intravenous 5-fluorouracil – based chemotherapy for first or second line treatment (1.1) Metastatic colorectal cancer, with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin containing regimen (1.1) • Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.(1.2) • Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy (1.3) - Effectiveness based on improvement in objective response rate. No data available demonstrating improvement in disease-related symptoms or survival with Avastin. • Metastatic renal cell carcinoma with interferon alfa (1.4)
WARNINGS AND PRECAUTIONS
Arterial Thromboembolic Events … Among patients receiving Avastin in combination with chemotherapy, the risk of developing ATE during therapy was increased in patients with a history of arterial thromboembolism, diabetes, or age greater than 65
FDA Update - Iclusig (ponatinib) tablets
BOXED WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY
Iclusig is a kinase inhibitor indicated for the: •Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315Ipositive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). •Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated. (1) These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.
FDA Drug Safety Communication: FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has approved label changes
The U.S. Food and Drug Administration (FDA) is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death.
Methylphenidate ADHD Medications: Drug Safety Communication - Risk of Long-lasting Erections
Including Concerta, Daytrana, Focalin/Focalin XR, Metadate CD/Metadate ER, Methylin/Methylin ER, Quillivant XR, Ritalin/Ritalin LA/Ritalin SR
FDA is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism
Researchers Detail Possible Resistance Mechanisms of Colorectal Cancer to Bevacizumab (Avastin)
A University of Colorado Cancer Center study published in the journal PLoS One shows that when colorectal cancer is targeted by the drug bevacizumab (Avastin), tumors may switch dependence from VEGF-A, which is targeted by the drug, to related growth factors in including VEGF-C, VEGF-D and placental growth factor. This change to new growth-factor dependence may allow colorectal cancer to push past bevacizumab’s blockage of VEGF-A to continue to drive tumor growth
Big Pharma pays record money to medical doctors
Spending by major pharmaceutical companies to U.S. doctors exceeded $1 billion in 2012, according to some newly released figures.
NSAID Painkillers Found To Deplete Vitamin B-6 Levels
New research has determined that COX-inhibitors, which include numerous NSAIDs - Nonsteroidal anti-inflammatory drugs – reduce Vitamin B-6 levels within the body. The study, published in the American Journal of Clinical Nutrition, tested 150 patients with rheumatoid arthritis. Some of the patients were treated with cyclooxygenase (COX) -inhibitor treatments while some were not. After six months of treatment, the researchers compared the two groups for their blood levels of pyridoxal-phosphate – the active form of vitamin B-6. The researchers found that the patients taking NSAIDs had significantly reduced levels of circulating vitamin B-6.
The Selling of Attention Deficit Disorder
The Number of Diagnoses Soared Amid a 20-Year Drug Marketing Campaign
After more than 50 years leading the fight to legitimize attention deficit hyperactivity disorder, Keith Conners could be celebrating. But Dr. Conners did not feel triumphant this fall as he addressed a group of fellow A.D.H.D. specialists in Washington. He noted that recent data from the Centers for Disease Control and Prevention show that the diagnosis had been made in 15 percent of high school-age children, and that the number of children on medication for the disorder had soared to 3.5 million from 600,000 in 1990. He questioned the rising rates of diagnosis and called them “a national disaster of dangerous proportions.”
“The numbers make it look like an epidemic. Well, it’s not. It’s preposterous,” Dr. Conners, a psychologist and professor emeritus at Duke University, said in a subsequent interview. “This is a concoction to justify the giving out of medication at unprecedented and unjustifiable levels.”
Pfizer loses its Supreme Court bid to squash $142M Neurontin verdict
It was March 2010 when Pfizer ($PFE) first lost its bid to escape a $142 million racketeering verdict, with a federal jury ruling the company's marketing of epilepsy treatment Neurontin violated both federal and state law. Now, nearly four years later, Pfizer's appeal process has come to the end of the line. The Supreme Court has refused to hear the drugmaker's appeal, leaving the verdict intact and the door open for similar claims to proceed.
Valium (diazepam) Tablets - Safety Labeling Changes
Valium is used to treat anxiety disorders, alcohol withdrawal symptoms, or muscle spasms. Valium is sometimes used with other medications to treat seizures
ADVERSE REACTIONS - Postmarketing Experience
Injury, Poisoning and Procedural Complications: There have been reports of falls and fractures in benzodiazepine users. The risk is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly.
Amerge (naratriptan) Tablets - Migraine Medication - label changes
AMERGE is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults.
WARNINGS AND PRECAUTIONS
Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with Amerge. Amerge is contraindicated in patients with uncontrolled hypertension.
There have been reports of anaphylaxis and anaphylactoid and hypersensitivity reactions, including angioedema, in patients receiving Amerge. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Amerge is contraindicated in patients with a history of hypersensitivity reaction to Amerge.
Oral Contraceptives - Cardiovascular Risk Associated With Smoking
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including ORTHO-NOVUM and MODICON, ORTHO TRI-CYCLEN and ORTHO-CYCLEN, and Ortho-Cept should not be used by women who are over 35 years of age and smoke.
An Award-Winning Documentary Tells the Story of Members of the Military who were Ordered Against their Will to Take the Controversial Anthrax Vaccine.
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
FDA investigating leukemia drug Iclusig (ponatinib) after increased reports of serious blood clots in arteries and veins
The U.S. Food and Drug Administration (FDA) is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) of patients taking the leukemia chemotherapy drug Iclusig (ponatinib).
Heart Disease Risk Appears Associated with Breast Cancer Radiation
Among patients with early stages of breast cancer, those whose hearts were more directly irradiated with radiation treatments on the left side in a facing-up position had higher risk of heart disease, according to research letter by David J. Brenner, Ph.D, D.Sc, of Columbia University Medical Center, New York, and colleagues. Several reports have suggested links between breast cancer radiation and long-term cardiovascular-related deaths, according to the study background
Did Antidepressant Play a Role in Navy Yard Massacre?
Once again, antidepressants have been linked to an episode of horrific violence. The New York Times reports that Aaron Alexis, who allegedly shot 12 people to death at a Navy facility in Washington, D.C., earlier this week, received a prescription for the antidepressant trazodone in August
FDA Tightens Opioid Labeling
The FDA has ordered a class-wide label change for long-acting opioids such as OxyContin (oxycodone) aimed at limiting use of these drugs to patients with severe, refractory pain.The move, announced at press briefing Tuesday, is part of a handful of changes that the agency hopes will curb an ongoing prescription painkiller epidemic, including a label clarification about the risks of abuse and death with the drugs, a requirement for additional postmarketing studies, and a boxed warning about the risks of neonatal opioid withdrawal syndrome.
FDA Drug Safety Communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems
The U.S. Food and Drug Administration (FDA) is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems and advising that it can lead to harmful drug interactions with other medications. FDA has approved label changes and added a new Medication Guide to address these safety issues. As a result, Nizoral oral tablets should not be a first-line treatment for any fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated. The topical formulations of Nizoral have not been associated with liver damage, adrenal problems, or drug interactions. These formulations include creams, shampoos, foams, and gels applied to the skin, unlike the Nizoral tablets, which are taken by mouth.
FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection
The U.S. Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones (see Table for a list) may occur soon after these drugs are taken and may be permanent.The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.
FDA investigating rare brain infection in patient taking Gilenya (fingolimod)
The U.S. Food and Drug Administration (FDA) is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod). This is the first case of this disease, called progressive multifocal leukoencephalopathy or PML, reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug associated with a higher risk of PML.
This Pharmaceutical Company Used NSA-Like Tactics to Monitor Parents’ Concerns About Vaccines
Pharma Collects Data on Your Vaccine Concerns All of the recent news of the National Security Administration (NSA) illegally monitoring your communications and personal life may bring this information into a different perspective for you. According to a recent news article, GlaxoSmithKline (GSK) hired a text analytic software company, called Luminoso, to find out what parents were most concerned about with vaccines.
Long-Term Survival of Participants in Prostate Cancer Prevention Trial Detailed
In the NCI-sponsored Prostate Cancer Prevention Trial (PCPT), initial findings from a decade ago showed that the drug finasteride significantly reduced the risk of prostate cancer, but among those who did develop prostate cancer, paradoxically, the drug was associated with an increased risk of high-grade disease. New findings reported in NEJM on August 15, 2013, based on follow-up of trial participants for up to 18 years, showed that survival of the men on finasteride was equivalent to men who did not take the drug and the reduction in risk of prostate cancer persists.
ADHD Drug Emergencies Quadrupled In 6 Years, Says Government Report
National data released by the Substance Abuse and Mental Health Services Administration (SAMHSA) show that Ritalin, Adderall, and other ADHD drugs sent almost 23,000 young adults to the emergency room in 2011, a more than four-fold increase from 2005, when just 5,600 such visits were reported.The population group studied was 18-34, but the rise was most dramatic among 18- to 25-year-olds, Federal officials say.
FDA Drug Safety Communication: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen
The U.S. Food and Drug Administration (FDA) is informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products. Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain acetaminophen. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken. Other drugs used to treat fever and pain/body aches (e.g., non-steroidal anti-inflammatory drugs, or NSAIDS, such as ibuprofen and naproxen) also carry the risk of causing serious skin reactions, which is already described in the warnings section of their drug labels.
FDA Drug Safety Communication: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects
The U.S. Food and Drug Administration (FDA) is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label.
The neurologic side effects can include dizziness, loss of balance, or ringing in the ears. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations Neurologic side effects can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent
Chinese police pick up AstraZeneca sales rep for questioning
Now, China is putting the heat on AstraZeneca. Police visited the company's operations in Huangpu Friday and took a sales rep away for questioning. Whether the move against AstraZeneca ($AZN) is part of China's new crackdown on corruption in the pharma industry isn't clear. In a statement, the company said the visit was part of a "local police matter" and tried to distance itself from the fast-moving GlaxoSmithKline ($GSK) bribery scandal
GlaxoSmithKline executive in China TV 'confession'
One of four senior GlaxoSmithKline executives detained in China over allegations of corruption has made a confession on state television. The executive, a Chinese national, confessed to paying bribes and said his actions had pushed up drug prices.
Inspector General Faults Medicare for Not Tracking ‘Extreme’ Prescribers
More than 700 doctors nationwide wrote prescriptions for elderly and disabled patients in highly questionable and potentially harmful ways, according to a critical report of Medicare's drug program
FDA Panel Loosens Noose on Avandia
A panel of FDA advisers thinks it is time to ease restrictions on access to Avandia (rosiglitazone), a onetime multimillion dollar blockbuster drug brought low by reports that it increased the risk of heart attacks.
In a combined meeting of separate FDA advisory committees, 20 of 26 panelists voted Thursday to recommend removing or modifying rosiglitazone's highly restrictive label and distribution system. Five voted to keep the product's risk evaluation and mitigation strategy (REMS) as it is now. One panelist voted to remove the product from the market.
Cholesterol drug may block exercise benefits
Experts urge doctors to reconsider statins for obese patients after finding the cholesterol drug may block some benefits of exercise. Statins, the most widely prescribed drugs worldwide, are often suggested to lower cholesterol and prevent heart disease in individuals with obesity, diabetes, and metabolic syndrome, which is a combination of medical disorders including excess body fat and/or high levels of blood pressure, blood sugar, and/or cholesterol. Researchers, however, found that simvastatin, a generic type of statin previously sold under the brand name Zocor, hindered the positive effects of exercise for obese and overweight adults.
Gaia Health - Vaccines Do Irreparable Harm: Study from Poland
The authors of this powerful new review wrote: “It is not reasonable to assume that manipulation of the immune system through an increasing number of vaccinations during critical periods of brain development will not result in adverse neurodevelopmental outcomes.” Here’s what they found.
FDA Drug Safety Communication: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children
Valproate products include: valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics
The U.S. Food and Drug Administration (FDA) is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant.1 Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant women clearly outweighs any possible benefit of the drug).With regard to valproate use in pregnant women with epilepsy or bipolar disorder, valproate products should only be prescribed if other medications are not effective in treating the condition or are otherwise unacceptable. Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder.
Jury awards plaintiff $6.5 mln in first Takeda Actos trial
A California jury has awarded $6.5 million to a man who accused the Japanese drugmaker Takeda Pharmaceutics of failing to provide an adequate warning that its diabetes drug Actos could cause bladder cancer.
The case in Los Angeles Superior Court is one of over 3,000 lawsuits pending in courts across the country over the medication and was the first to go to trial and reach a verdict. Another 200 suits are consolidated in California state court; some 1,500 are in Illinois state court in Cook County; and another 1,200 are in multidistrict litigation in the U.S. District Court for the Western District of Louisiana.
Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death
FDA has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially leading to liver transplant or death. FDA has worked with the manufacturer to revise the Samsca drug label to include new limitations.
Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion
The FDA notified health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine) in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab) and may result in medication errors. The dosing and treatment schedules for Kadcyla and Herceptin, another breast cancer drug, are quite different, so confusion between these products could lead to dosing errors and potential harm to patients.
Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration
The anti-seizure medication Potiga (Ezogabine) can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. FDA is working with the manufacturer to gather and evaluate all available information to better understand these events. FDA will update the public when more information is available. Potiga is approved as adjunctive (added on to other anti-seizure medications) treatment of partial-onset seizures in adult patients 18 years and older. The skin discoloration in the reported cases appeared as blue pigmentation, predominantly on or around the lips or in the nail beds of the fingers or toes, but more widespread involvement of the face and legs has also been reported. Scleral and conjunctival discoloration, on the white of the eye and inside eyelids, has been observed as well. The skin discoloration generally occurred after four years of treatment with Potiga, but has appeared sooner in some patients. In some cases, retinal abnormalities have been observed in the absence of skin discoloration.
Two cases of progressive multifocal leukoencephalopathy (PML) in Europe with Fumarate
Two cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients treated with oral dimethyl fumarate, a form of which won FDA approval last month for multiple sclerosis.
One patient in the Netherlands and another in Germany developed PML after several years of treatment with European formulations of the drug, long available as psoriasis treatments, according to two separate case reports in the April 25 issue of the New England Journal of Medicine.
Both patients had psoriasis, although the Dutch patient had developed neurological symptoms leading to a diagnosis of "possible" MS 6 months before PML was detected.
In a response also published in the NEJM, researchers from dimethyl fumarate's U.S. manufacturer, Biogen Idec, said they were aware of two other cases of PML in patients taking drugs containing dimethyl fumarate, both involving its European product sold as Fumaderm.
U.S. sues Novartis, alleging kickbacks to pharmacies
The U.S. government filed a civil fraud lawsuit against Novartis AG on Tuesday, accusing a unit of the Swiss drug maker of causing the Medicare and Medicaid programs to pay tens of millions of dollars in reimbursements based on fraudulent, kickback-tainted claims.
U.S. Attorney Preet Bharara in Manhattan said Novartis Pharmaceuticals Corp had since 2005 induced at least 20 pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic from competitors' drugs, in exchange for kickbacks disguised as rebates and discounts.
Epilepsy drug in pregnancy tied to autism risk
Women who take the epilepsy drug valproate during pregnancy are three times more likely to have a child with an autism spectrum disorder, suggests new research based on close to 700,000 babies born in Denmark.
Previous studies have found more birth defects and lower intelligence among children of mothers who took valproate, but the new work represents the "strongest evidence to date" of a link between the drug and autism,
FDA Lets Drugs Approved on Fraudulent Research Stay on the Market
The FDA in 2011 announced years' worth of studies from a major drug research lab were potentially worthless, but it has not pulled any of the compounds from the market nor identified them
Amiodarone Linked to Cancer Risk in Men
The risk of cancer was increased in men taking the antiarrhythmia drug amiodarone (Nexterone), particularly in those with extensive exposure to the drug, a retrospective study found.
Nonsteroidal Anti-inflammatory Drugs and Risk of Atrial Fibrillation: Is There a Relationship?
"With these cautions in mind, evidence from these studies suggest that AF is an additional cardiovascular risk associated with NSAIDs,2,5 with the strongest association evident for new users and individuals who take NSAIDs for longer periods of time. These findings have clinically significant implications due to the high rate of administration of NSAIDs to treat pain and inflammation associated with a wide variety of musculoskeletal and other conditions. This is particularly important for older adults, who are at increased risk of AF by virtue of their advanced age. Of greatest concern, of course, are older patients who have been diagnosed with hypertension or heart failure and are already at increased risk for the adverse effects of NSAIDs because of these conditions."
Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury
Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and its open-label extension trial, 3 patients treated with the drug developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in serum total bilirubin. In the trials the maximum daily dose of Samsca administered (90 mg in the morning and 30 mg in the afternoon) was higher than the maximum 60 mg daily dose approved for the treatment of hyponatremia.
FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy
The U.S. Food and Drug Administration (FDA) is updating the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to remove the tonsils and/or adenoids). Deaths have occurred post-operatively in children with obstructive sleep apnea who received codeine for pain relief following a tonsillectomy and/or adenoidectomy. Codeine is converted to morphine by the liver. These children had evidence of being ultra-rapid metabolizers of codeine, which is an inherited (genetic) ability that causes the liver to convert codeine into life-threatening or fatal amounts of morphine in the body.A new Boxed Warning, FDA’s strongest warning, will be added to the drug label of codeine-containing products about the risk of codeine in post-operative pain management in children following tonsillectomy and/or adenoidectomy.
Pediatric clinical studies of Sensipar (cinacalcet hydrochloride) suspended after report of death
Sensipar is a medication used to decrease the release of parathyroid hormone (PTH) from the parathyroid gland. Sensipar lowers high PTH levels leading to lower calcium levels in the blood; when calcium levels are too low it can result in health problems. FDA has approved Sensipar for use in adults but not in children (less than 18 years of age), and the clinical studies were underway to determine if the drug is effective and can be used safely in children.
The U.S. Food and Drug Administration (FDA) has placed a clinical hold on all pediatric clinical studies of Sensipar (cinacalcet hydrocloride) after the company that makes the drug, Amgen, suspended the studies after the recent death of a 14-year-old patient in a study.
FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms
Azithromycin (Zithromax, Azithrocin, Zmax, Azin) is an azalide, a subclass of macrolide antibiotics. Azithromycin is one of the world's best-selling antibiotics.
The U.S. Food and Drug Administration (FDA) is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias.
FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes
Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Heart risk rises with breast cancer radiation
The radiation that might cure a breast cancer may also raise a woman's risk of having a heart attack or heart disease later in life, according a new study that looked back at the cases of 2,168 women in Sweden and Denmark. The risk "begins within a few years after exposure, and continues for at least 20 years," the researchers report in the New England Journal of Medicine. And that risk rises, they found, in proportion to the dose of radiation the heart receives.
Too many drug types are compromising heart health: doctors
About 80 million Americans suffer from heart disease, the nation's No. 1 killer, and most are on multiple drugs. Some cardiologists think prescribing has gotten out of hand.
Doctors Paid Millions to Shill for Big Pharma
How the pharmaceutical industry bribes medical professionals.
The Dangers of a Hepatitis B Vaccination for Your Baby
Brand new one day old babies are routinely injected with the hepatitis B vaccine in US hospitals, yet it can be very dangerous and is completely unnecessary. Hepatitis B is a disease spread most often by unprotected sex and infected drug needles neither of which the average newborn will participate in. The disease is about as hard to catch as the HIV virus yet no where near as dangerous. 90-95% of all hepatitis B cases completely recover after a few weeks of symptoms such as headache, nausea and fatigue. The disease is far from deadly and the people who are at risk of getting hepatitis B are IV drug users, prostitutes and other adults with multiple unprotected sexual encounter, prisoners, and babies born to infected mothers. Pregnant women are tested during pregnancy and unless they are positive carriers of the hepatitis B virus, their newborn should not have to receive this vaccination. Yet since 2002 this shot has been added to the recommended immunization schedule and many US hospitals give it to newborn babies before they even leave go home.
The Gardasil Timeline – A History of Corruption and Negative Reactions
The HPV shot Gardasil has a history that is not only filled with adverse reactions and death, but also political corruption. In fact, many are completely unaware as to what extent Gardasil was pushed on the public using bribery, omission of numerical facts, and complete lies. With so much news coming out on the Gardasil vaccine, it is a challenge to keep up with the documentation. Without seeing the recent history of Gardasil, you simply cannot put together all of the pieces. The Gardasil timeline unveils how Merck, the manufacturer of Gardasil, is working behind the scenes to put profits over the health of you and your family. Evidence Mounts: 49 Girls Die, Thousands of Others Hospitalized After Receiving the Gardasil Vaccine The evidence linking Gardasil to adverse reactions and death was available long before legislators began pushing it on pre-pubescent children. Shockingly, the HPV shot led to 3,589 harmful reactions and 16 deaths between May 2009 and September 2010 alone. Of the 3,589 adverse reactions, many were debilitating. Permanent disability was the result of 213 cases; 25 resulted in the diagnosis of Guillain-Barre Syndrome; there were 789 other “serious” reports according to FDA documents.
Fatal Reactions Prompt Omontys Recall
All lots of the new anemia drug peginesatide (Omontys) have been recalled because of severe hypersensitivity reactions -- some fatal -- observed after the drug was approved last March.
Antidepressants Can Cause Sudden Death
Most antidepressants cause a change in the electrical pulse of the heart, which changes the rhythm of the heart beat. It’s called an extended QT interval—and it can result in sudden death with no warning of any kind: BMJ study.
Diclofenac Used and Recommended Globally, Despite Cardiovascular Risks
A study in this week's PLOS Medicine finds that the painkiller diclofenac (a non-steroidal anti-inflammatory drug (NSAID) in the same class as aspirin) is the most commonly used NSAID in the 15 countries studied and is included in the essential medicines lists of 74 low-, middle- and high-income countries, despite its known tendency to cause heart attacks and strokes in vulnerable patients. This risk is almost identical to that of Vioxx (rofecoxib), which was withdrawn from worldwide sales in 2004 because of cardiovascular risk. Researchers writing in this week's PLOS Medicine call for diclofenac to be removed from national essential medicines lists and to have its global marketing authorisations revoked.
MS Patient Dies From Anti-Drug Antibodies
A reaction to anti-natalizumab (Tysabri) antibodies appears to have killed a Swedish woman with multiple sclerosis who received the drug, researchers said.
Significant neurological abnormalities developed after she had received six infusions of natalizumab, and her doctors found that she had extremely high titers of antibodies against the drug,
FDA Panel Votes for Tighter Controls on Vicodin
An FDA advisory committee voted 19 to 10 on Friday in favor of moving hydrocodone combination drugs such as Vicodin, Lortab, and Norco into the more restrictive schedule II category of controlled substances.The majority of panelists involved in the 2-day hearing believe the evidence suggests that the drugs are pharmacologically similar to and as susceptible to abuse as other opioids, such as oxycodone combination drugs like Percocet, that fall into the more tightly regulated class.
German doctors shaken by corruption allegations
The German Medical Association has investigated nearly 1,000 cases of corrupt doctors over the past few years, according to its president, Frank Ulrich Montgomery. Dr Montgomery told Der Spiegel that more than half of the case involved alleged bribes from an Israeli pharmaceutical company, Ratiopharm. The doctors were paid for prescribing its drugs to their patients. This was “clearly prohibited”, says Dr Montgomery.
FDA Warns of Liver Injury Risk with Tolvaptan/Samsca
Samsca is used to treat hyponatremia (low levels of sodium in your blood) in people with heart failure, liver disease, and certain hormonal imbalances. Samsca improves urine flow without causing the body to lose too much sodium as you urinate. Tolvaptan is also in fast-track clinical trials for polycystic kidney disease
Three cases of serious but reversible increases in hepatic enzymes in a clinical trial involving tolvaptan (Samsca) have prompted the FDA to warn of potential liver injury with the drug.
Aspirin Use Linked to Macular Degeneration
Regular aspirin use was associated with an elevated risk for neovascular age-related macular degeneration, an Australian study suggested, but actual causality remains uncertain.
Advance Pharmaceutical Issues Nationwide Voluntary recall of one Lot (# 12G468) of Ferrous Sulfate Tablets, 325 mg, that may actually contain Meclizine HCl 25 mg tablets
Consumers who take three tablets daily of the defective product for treatment of iron deficiency will would be inadvertently ingesting 75 mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine drug products of 100 mg. Consumption of meclizine three times a day instead of once daily as monograph recommended is likely to lead to significant drug accumulation because it is a long-acting drug with effects that may persist up to 24 hours after a single dose. Meclizine toxicity may lead to dose-related serious adverse events, including impaired alterness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. Without supportive treatment meclizine toxicity has the potential to be life-threatening.
Court Awards $969,474.91 for MMR Vaccine Causing Boy’s Autism
According to a document filed on December 13, 2012, Chief Special Master Patricia E. Campbell-Smith awarded Ryan B. Mojabi $969,474.91 for injuries caused by the MMR vaccine.  You should also know the money awarded comes from a vaccine tax and not from taking the vaccine manufacturers to court.
Merck begins overseas recall of HDL cholesterol drug
Merck & Co said it is recalling Tredaptive, its medicine to raise "good" HDL cholesterol levels, in overseas markets where it is sold, after it failed to prevent heart problems in a large study and raised safety concerns.
Patients rarely told about medication errors
Patients and their families are rarely told when hospitals make mistakes with their medicines, according to a new study.
Settlement reached in Boston lawsuit claiming mom's pregnancy drug caused 4 daughters' cancer
Eli Lilly and Co. has settled a lawsuit brought by four sisters who contended their breast cancer was caused by a drug their mother took during pregnancy in the 1950s, a move some believe could trigger financial settlements in scores of other claims brought by women around the country. A total of 51 women, including the Melnick sisters, filed lawsuits in Boston against more than a dozen companies that made or marketed a synthetic estrogen known as DES.
Zolpidem Containing Products: - FDA Requires Lower Recommended Doses Including Ambien, Ambien CR, Edluar, and Zolpimist
FDA is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving
Serious Allegations against HPV Vaccine Trials Affecting Thousands of Girls Accepted by Supreme Court of India
On January 7, 2013, Ms. Leslie Carol Botha, Women’s Health Educator and long-time advocate for HPV vaccine safety awareness , released an urgent article entitled: India Women Activists Historic Writ of Petition Accepted by Supreme Court over Unethical Trialing of HPV Vaccines, Gardasil® and Cervarix®.
Based on the press release issued by Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao, representing Gramya Resource Centre for Women from Andhra Pradesh, titled, “India Supreme Court Accepts Writ of Petition on Gardasil & Cervarix Licensing & Trial Violations” implicating the Drug Controller of India, PATH, ICMR and others, ordering the government of India to immediately respond.
Prescription Drug Misuse Remains a Top Public Health Concern
Prescription drug misuse is second only to marijuana as the nation’s most prevalent illicit drug problem, with approximately 22 million persons nationwide initiating nonmedical pain reliever use since 2002, according to a report by the Substance Abuse and Mental Health Services Administration (SAMHSA).
Psych meds linked to 90% of school shootings
Some 90 percent of school shootings over more than a decade have been linked to a widely prescribed type of antidepressant called selective serotonin reuptake inhibitors or SSRIs, according to British psychiatrist Dr. David Healy, a founder of RxISK.org, an independent website for researching and reporting on prescription drugs.
Cough Syrup Suspected to Have Killed 33 in Pakistan
The Pakistani authorities are investigating claims that cough syrup has killed 33 people over the past three days, a government official said Saturday, the second time in recent months that medicine is suspected of causing multiple deaths.
Hep C Drug Linked to Fatal Skin Reactions
The oral hepatitis C drug telaprevir (Incivek) will now carry a boxed warning about potentially fatal skin reactions in the wake of multiple deaths,
Commonly Prescribed Antibiotic, Amoxicillin, Ineffective for Treating Uncomplicated Chest Infections, Study Suggests
The antibiotic amoxicillin, that doctors typically prescribe for common lower respiratory tract infections (LRTI) such as bronchitis, is no more effective at relieving symptoms than the use of no medication, even in older patients. The findings are from the largest randomised placebo controlled trial of antibiotics for acute uncomplicated LRTI to date
FDA risk finding adds fuel to fire around Pfizer's Chantix
The FDA says Pfizer's ($PFE) smoking-cessation drug Chantix is probably the cause of higher risk for heart attacks among those who use it, but it can't be sure. It says it's certain that smoking can kill you and Chantix can help some people stop
Sedatives May Raise Risk of Pneumonia
Taking benzodiazepines may raise the risk of pneumonia as well as the likelihood of dying from the disease, researchers found
High-Dose Zofran Pulled From Market
The 32-mg dose of the anti-nausea drug ondansetron (Zofran) has been pulled from the market because of concerns about cardiac problems
More Bad News for Avastin in Breast Cancer
A randomized trial found bevacizumab (Avastin) failed to improve outcomes in combination with chemotherapy in early triple-negative breast cancer, adding to the string of failures for the drug
How Drug Company Money Is Undermining Science
The pharmaceutical industry funnels money to prominent scientists who are doing research that affects its products--and nobody can stop it
Seniors Need to Be Wary When Starting BP Meds
Older hypertensive patients may be at risk for hip fracture after initiation of blood pressure-lowering therapy, researchers found. The risk for hip fracture was a relative 43% greater in the month-and-a-half after starting on any antihypertensive compared with other time periods
Use of SSRIs in Pregnancy Puts Baby at Risk
Pregnant women who took antidepressants were at risk for miscarriage and preterm delivery, and their babies were at risk for a number of developmental and health complications, researchers found.
Antibiotics Don't Ease Coughs in Kids With Common Cold: Study
No treatment is sometimes the best option, experts say
Children with a cough associated with the common cold should not be given antibiotics, according to a new study. Although they are not effective in treating this type of cough, researchers in Italy said many children are prescribed antibiotics anyway.
Die Early with Sleeping Pills
A new study shows prescription sleeping pills bring an increased risk of dying early—or getting cancer
Flu Shots May Not Protect the Elderly or the Very Young
Despite government recommendations, there is little evidence that flu vaccines help individuals older than 65 or younger than two
Rx Drug Abuse Up, Illicit Drug Use Wanes
As abuse of prescription painkillers continues to rise, patients are using fewer illicit drugs, researchers said
The incidence of abuse of oxycodone (OxyContin) and other prescription painkillers rose about 1 percentage point each year between 2007 and 2009, rates of illicit drug use -- that includes marijuana, cocaine, and heroin -- fell 4 percentage points each year during that time
SSRIs Linked to Risk of Stroke
Use of the selective serotonin reuptake inhibitors (SSRI) class of antidepressants conferred a small, but statistically significant risk of brain hemorrhage, according to an analysis of multiple epidemiologic studies.
Mirapex (pramipexole): Drug Safety Communication - Ongoing Safety Review, Possible Risk of Heart Failure
Mirapex (pramipexole) is a prescription medicine used to treat the signs and symptoms of Parkinson's disease and moderate to severe symptoms of primary restless legs syndrome, in a class of medicines called dopamine agonists
Worrying Trends Confronted in Prescription Drug Abuse
In the most recent analysis of all overdose deaths in the U.S., more than 40 percent involved prescription narcotics.
A Call for Safer Drugs for Kids
Many of the medicines children take have never been proved safe and effective for them. A new law will help change that
Anatomy of an Epidemic: The Opioid Movie
Purdue Pharma's marketing of OxyContin in the late 1990s marked the beginning of the industry's push to promote narcotic painkillers for treatment of chronic pain -- an indication for which both safety and efficacy remain unproven.
Study Suggests Early Exposure to Antibiotics May Impact Development, Obesity
“This work shows the importance of the early life microbiome in conditions like obesity,” said lead investigator Martin J. Blaser, MD, Frederick King Professor of Medicine and chair of the Department of Medicine at NYU Langone Medical Center. “The rise of obesity around the world is coincident with widespread antibiotic use, and our studies provide an experimental linkage. It is possible that early exposure to antibiotics primes children for obesity later in life.”
FDA Warns of Deaths with Postop Codeine in Children
FDA issued a warning of a potentially fatal risk associated with the use of codeine in children following tonsillectomy and adenoidectomy.
FDA Drug Safety Communication: Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine)
FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine). The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures
The 50-year global cover-up
SECRET files reveal the German maker of thalidomide ignored and covered up repeated warnings that its drug could damage unborn babies.
Johnson & Johnson - Risperdal, Invega, Natrecor, Levaquin, Procrit
Settlement amount: Reportedly between $1.6 billion and $2.2 billion
Drugs: Risperdal, Invega, Natrecor, Levaquin, Procrit, according to press reports
Year: 2012 You might call Johnson and Johnson's ($JNJ) Risperdal settlement an omnibus deal. It is expected to cover federal probes about off-label Risperdal marketing, state claims of Medicaid fraud (also related to Risperdal), kickback allegations involving the nursing home pharmacy provider Omnicare and several other drugs besides Risperdal. It would also settle litigation over marketing practices involving Invega, another antipsychotic, and Natrecor, a congestive heart failure treatment. The company had already pleaded guilty to misbranding Natrecor and agreed to pay an $85 million fine.
Study Questions Safety and Effectiveness of Common Kidney Disease Drugs
Longest placebo-controlled trial of phosphate binders conducted to date challenges the drugs’ utility
• Phosphate binders, drugs commonly prescribed to patients with chronic kidney disease, may not be as effective as previously thought.
• Phosphate binders may have negative effects on cardiovascular health.
• Additional studies are needed on the safety and effectiveness of these drugs.
H1N1 Vaccine Associated With Small but Significant Risk of Guillain-Barre Syndrome
Over the 6-month period, 83 confirmed GBS cases were identified. Twenty-five confirmed cases had been vaccinated against 2009 influenza A(H1N1) 8 or fewer weeks before disease onset, with most (19/25) vaccinated 4 or fewer weeks before onset. Analysis of data indicated a small but significant risk of GBS following influenza A(H1N1) vaccination. The number of cases attributable to vaccination was approximately 2 per 1 million doses. The excess risk was observed only in persons 50 years of age or older.
OxyContin Remake Sends Abusers to Other Opioids
Reformulating OxyContin to make it less abusable has led drug users to switch to other opioids, particularly heroin, a survey showed.
Actos Bladder Cancer Risk Again Affirmed
The diabetes drug pioglitazone (Actos) appears to raise the risk of bladder cancer, but whether that is a class effect remains unclear, a meta-analysis affirmed. Any use of a thiazolidinedione was associated with a nonsignificant 45% higher risk in the pooled randomized trials and a significant 15% elevated risk across the observational studies, Jeffrey A. Johnson, PhD, of the University of Alberta in Edmonton, and colleagues found.
Antipsychotics in Pregnancy Up Diabetes Risk
Women who took antipsychotic drugs during pregnancy -- including those drugs thought to have less potential for unwanted metabolic effects -- were at increased risk for developing diabetes and giving birth to small infants, researchers said.
GlaxoSmithKline (GSK) is to pay $3bn (£1.9bn) in the largest healthcare fraud settlement in US history.
The drug giant is to plead guilty to promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA).
The settlement will cover criminal fines as well as civil settlements with the federal and state governments.
The case concerns the drugs Paxil, Wellbutrin and Avandia.
Deputy US Attorney General James Cole told a news conference in Washington DC that the settlement was "unprecedented in both size and scope".
FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran)
Adults and children with chemotherapy-induced nausea and vomiting - a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes.
Study: Dramatic Increase in Abuse of Rx Painkillers
The illicit use of prescription painkillers has increased dramatically in recent years, particularly among men ages 18 to 49, according to a new report.
Lotensin (benazepril hydrochloride) tablets
Blood Pressure Medication
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue Lotensin as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity
WARNINGS Anaphylactoid and Possibly Related Reactions
Head and Neck Angioedema
Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks
FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies
Prescription medicine approved in combination with dexamethasone to treat patients with multiple myeloma (a type of cancer of the bone marrow) who already have had prior therapy.
Also approved to treat certain patients who have certain types of myelodysplastic syndromes (a group of conditions in which the bone marrow does not produce enough mature blood cells)
FDA is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide)
FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)
An oral medication for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Used to reduce the frequency of flare-ups (clinical exacerbations) and to delay the progression of the physical symptoms of MS.
Gilenya is now contraindicated (FDA advises against its use) in patients with certain pre-existing or recent (within last 6 months) heart conditions or stroke, or who are taking certain antiarrhythmic medications.
Aspirin's Mostly Unrecognized Connection to Serious Medical Problems
Many Americans Taking Too Much Acetaminophen
Acetaminophen (Tylenol / Paracetamol) is the most commonly used over-the-counter pain medication in the United States, and acetaminophen overdose is the leading cause of acute liver failure,
New Study - Popular Antiobiotic Increases Risk of Death
A study published in the New England Journal of Medicine finds that the antibiotic may boost the risk of death by 250 percent. The analysis found there were 47 more deaths per million in those taking azithromycin compared to those on amoxicillin (an antibiotic safer on the heart).
Antidepressant Use Associated with Increased Mortality among Critically Ill Patients
Critically ill patients were more likely to die if they were taking the most commonly prescribed antidepressants when they were admitted to the intensive care unit (ICU).
Why are doctors still not warning about the 'new Thalidomide'? Mother tells how taking an anti-epileptic drug while pregnant devastated the heath of two of her children
Anti-epileptic drug Epilim and Fetal Anticonvulsant Syndrome (FACS) Dr Peter Turnpenny, clinical geneticist at the Royal Devon and Exeter Hospital, says: ‘Epilim may affect about 560 babies every year, and 10,000 to 20,000 since being introduced to the UK.’
NSAIDs and Cardiovascular Risk Explained
After nearly 13 years of study and intense debate, a pair of new papers from the Perelman School of Medicine, at the University of Pennsylvania have confirmed exactly how a once-popular class of anti-inflammatory drugs leads to cardiovascular risk for people taking it.
FDA Drug Safety Communication: New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna)
Warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, a new warning is being added to avoid use of these drug combinations in patients with kidney impairment.
FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone
Revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.
Evidence Shows That Anti-Depressants Likely Do More Harm Than Good
Herceptin Tied to Heart Issues in Breast Cancer
Off-label drug use could pose health risks
11 percent of medications are prescribed for an off-label indication, a practice that may cause adverse drug events. The study finds that 79 percent of those off-label uses lacked strong scientific evidence.
The only way to eradicate paralytic poliomyelitis is to stop vaccinating
Adverse reactions lead US patients to ask 'just how safe are antibiotics?'
Popular antibiotic ciprofloxacin linked to UK deaths
Revealed: the prescription drugs and medications most likely to harm or kill you
Fatal drugs and number of fatalities - Clozapine 1972, Ranibizumab 549, Infliximab 520
Adalimumab 295, Warfarin 191, Olanzapine 189, Methotrexate 177, Risperidone 167
Etanercept 162, Paracetamol 162
J&J's Marketing of Risperdal Violated Law, Arkansas Jury rules
“false or deceptive acts” sent a 2003 letter touting Risperdal as safer than competing drugs to more than 6,000 doctors across the state. The state is seeking more than $1.25 billion in penalties over the Risperdal marketing campaign, and a judge will decide later whether to fine J&J.
Annual childhood flu vaccines may interfere with development of crossresistance
Vaccinating children annually against influenza virus interferes with their development of cross-reactive killer T cells to flu viruses generally
Inside the Growing Prescription Pill Epidemic That's Ravaging Communities
Paralysis Cases Spike in Wake of Bill Gates’ Polio Vaccination Effort in India
How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data
Overall, admission rates are consistent with the highest estimates of misconduct obtained using other sources of data, in particular FDA data audits. However, it is likely that, if on average 2% of scientists admit to have falsified research at least once and up to 34% admit other questionable research practices, the actual frequencies of misconduct could be higher than this.
FDA Drug Safety Communication: Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury
FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses
Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide).
FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs
Monitoring Liver Enzymes, Adverse Event Information, Drug Interactions
Insight: New doubts about prostate-cancer vaccine Provenge
Doctors who raised doubts about it received death threats. Health regulators and lawmakers faced loud protests at their offices. A physician at the American Cancer Society was so intimidated by Provenge partisans that he yanked a skeptical discussion of it from his blog.
J&J in court over mis-marketing 'dangerous' antipsychotic drug
Risperdal - claims that the drug's side effects were suppressed.
Psychiatric adverse drug reactions reported during a 10-year period in the Swedish pediatric population
Psychiatric ADRs in the pediatric population have been reported for a wide range of reactions and drugs and display age and sex differences including a higher number of suicidal reactions in boys. An association was seen between serious reactions and off-label drug use.
Pharmacists paid by drug company for patient details
VIDEO - Dr John Rengen Virapen, Whistleblower of the Pharmaceutical Industry, Speaks Out
Part 1 of 4
GlaxoSmithKline chief's pay package more than doubles to £6.7m
Government nixes tentative $1 billion settlement with J&J: WSJ
Federal prosecutors in Washington, D.C. have nixed a tentative $1 billion settlement with Johnson & Johnson, holding out for a bigger settlement with the drugmaker for alleged improper marketing of its Risperdal schizophrenia drug
FDA Adds Diabetes Warning to Statin Label
Sleeping Pill Death Toll May Top 500,000
The use of hypnotic sleep aids was associated with a three- to five-fold higher mortality risk compared with the risk for nonusers, even when the prescription was for a small number of pills, investigators reported.
FDA Drug Safety Communication: Important drug interactions between Victrelis (boceprevir) and ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitor drugs
FDA is notifying healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together.
FDA Drug Safety Communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)
FDA is informing the public that the use of stomach acid drugs known as proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). A diagnosis of CDAD should be considered for patients taking PPIs who develop diarrhea that does not improve.
Deadly Duo: Mixing Alcohol and Prescription Drugs Can Result in Addiction or Accidental Death
Alcohol and Xanax, both found in Whitney Houston's hotel room right after she died, inhibit the central nervous system and depend on the same enzyme for bodily clearance
Antibiotics Won't Cure Sinus Infections
“Patients don’t get better faster or have fewer symptoms when they get antibiotics,”
Novartis to revamp Rasilez label with safety risks
Novartis blood-pressure drug will get a new warning in Europe at regulators' request, after a recent trial flagged links to stroke and kidney problems.
Brand name drugs cost Medicare the most
The Truly Staggering Cost Of Inventing New Drugs
Formaldehyde in Vaccines: A DNA Adduct?
'Inactive' phthalates widespread in medications
FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
FDA is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn's disease.
FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)
Used to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma
(FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin).
Drug Companies Fight Take-Back Program for Unused Medicine
Leftover medications are fueling an epidemic of prescription-drug abuse that is killing more Washingtonians than traffic accidents, say drug-addiction experts. Yet pharmaceutical companies have consistently torpedoed efforts here to fund a statewide disposal program for unused drugs.
Melanoma Drug's Link to Second Cancers Explained
BRAF inhibitors, when used to treat patients with melanoma who harbor the BRAF V600E mutation, can lead to the remission of even advanced lesions. However, resistance to BRAF inhibitors emerges within months and there can be the development of secondary tumors, most commonly cutaneous squamous-cell carcinomas and keratoacanthomas.
Cancer drug gets stronger label warning
Second instance of a patient on cancer drug Adcetris developing a deadly brain infection
Statins Up Diabetes Risk in Older Women
Researchers - Older women who take statins may be at an increased risk for developing type 2 diabetes,
Pradaxa Linked to More MIs in Certain Patients
Anticoagulant dabigatran (Pradaxa) was associated with greater odds of myocardial infarction (MI) or acute coronary syndrome than control treatments, a meta-analysis showed
FDA Warns of Opioid Drug Mix-Up
The FDA has issued a warning that pills, tablets, or caplets of Percocet and eight other opioid products packaged by Novartis for Endo Pharmaceuticals may have been mixed up, with one drug being packaged as another.
Statins Tied to Lung Damage in Smokers
High Cholesterol medication (Statins) use appears to be associated with interstitial lung abnormalities among current and former smokers, researchers found.
Drug Companies Reduce Payments to Doctors as Scrutiny Mounts
Purdue: Block Disclosure Of OxyContin Documents
FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod)
An oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults. Used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability.
FDA Drug Safety Communication: Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events
Multaq is used to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted
The Champion of Painkillers
Narcotic painkillers overdoses now kill nearly 15,000 people a year -- more than heroin and cocaine combined. In some states, the painkiller death toll exceeds that of car crashes.
Gardasil boys come marching in – 4 new Gardasil deaths reported to VAERS
Canadian judge rules SSRI antidepressants like Prozac can cause children to commit murder
FDA Drug Safety Communication: Kombiglyze XR (Saxagliptin/metformin hydrochloride Tabs
Tablets approved in the U.S. for the treatment of type 2 diabetes mellitus in adults + serious hypersensitivity reactions + Pancreatitis
FDA Drug Safety Communication: Dilantin (phenytoin) Oral Suspension
Indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.
- Coadministration of Dilantin is contraindicated with delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including Dilantin. Some of these events have been fatal or life-threatening.
- The chronic use of phenytoin in patients with epilepsy has been associated with decreased bone mineral density (osteopenia, osteoporosis, and osteomalacia) and bone fractures. ...
FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies
Antidepressants during pregnancy + reports of rare heart and lung conditions in newborn babies
FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)
A blood thinner (anticoagulant) known as a direct thrombin inhibitor.
Courts Rule that Prempro Causes Cancer, but FDA Still Promotes It
Hormone Replacement Therapy know to increase risk of Breast Cancer
Bayer Withheld Yasmin Data From U.S., Former Agency Chief Says
A Bayer AG unit withheld from U.S. regulators findings by company researchers of increased reports of blood clots in users of its Yasmin birth-control pills, the former head of the Food and Drug Administration said.
More Detail on Risk Urged for a Contraceptive Label
Labels on the popular birth control pills Yaz and Yasmin should be strengthened to include more information about the possibility that the pills could lead to greater risk of blood clots in women
Antidepressents - Can anti-depressants cause people to kill themselves, or even kill others? - VIDEO
60 Minutes News Programme - New Zealand
Merck & Co agrees $1bn Vioxx settlement in US
Painkiller - Vioxx
FDA Drug Safety Communication:Review update of Trilipix (fenofibric acid) and the ACCORD Lipid trial
May not lower a patient's risk of having a heart attack or stroke.
Facts about Trilipix (fenofibric acid)
- A prescription medicine used to treat cholesterol in the blood by lowering low-density lipoprotein (LDL) cholesterol ("bad cholesterol"), and increasing the high-density lipoprotein (HDL) cholesterol ("good cholesterol").
- Can be used to lower very high levels of fat (triglycerides) in the blood to help reduce the risk for pancreatitis.
- Can be used in combination with other cholesterol-lowering medicines called statins in patients at high risk for cardiovascular disease.
FDA Drug Safety Communication: UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy
TNF blockers include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab).
A class of biologic products that are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis
FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults
- methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR)
- dexmethylphenidate HCl (Focalin, Focalin XR)
- dextroamphetamine sulfate (Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat)
- lisdexamfetamine dimesylate (Vyvanse)
- amphetamine, mixed salts (Adderall, Adderall XR)
- methamphetamine (Desoxyn)
- pemoline (Cylert-no longer marketed)
- atomoxetine (Strattera)
FDA Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp
ESAs are approved for the treatment of anemia (low red blood cells) resulting from chronic kidney failure, chemotherapy, certain treatments for Human Immunodeficiency Virus (HIV), and also to reduce the number of blood transfusions during and after certain major surgeries.
US lawsuit extends thalidomide's reach - Drug blamed for a broader range of harmful effects.
ADHD drugs 'common source of drug reactions'
Drugs for attention deficit hyperactivity disorder were the most common source of yellow card reports in children after vaccinations, a new analysis reveals.
FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events
A prescription medicine used to help adults quit smoking. Works by blocking the effects of nicotine (from smoking) on the brain. From approval in May 2006 through July 2011, approximately 21.8 million Chantix prescriptions were dispensed and approximately 8.9 million patients received Chantix prescriptions from U.S. outpatient retail pharmacies.
Sprycel (dasatinib) and risk of pulmonary arterial hypertension
Used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).
Abbott earmarks $1.5B for off-label Depakote settlement
Ranked as the second-biggest off-label settlement in history, outranked only by Pfizer's $2.3 billion deal.
VA puts cork in Avastin use for eye disease
Controversial use of Roche's cancer drug for wet age-related macular degeneration
More eye patients go blind after Avastin injections
Roche's cancer drug for wet age-related macular degeneration
Gut Biota Never Recover from Antibiotic Use: Loss Extends to Future Generations
Birth control pills may alter memory
Patients Deserve to Know What Drug Companies Pay Their Doctor
FDA Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid)
Used to treat or prevent osteoporosis in women after menopause. Reclast helps reduce the chance of having a hip or spinal fracture (break).
Used to increase bone mass in men with osteoporosis.
Used to treat or prevent osteoporosis in either men or women who take corticosteroid medications for at least one year.
Used to treat men and women who have Paget's disease of the bone.
Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions
FDA is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris (asenapine maleate). Also prescribed for Bipolar disorders.
FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide)
The antidepressant Celexa (citalopram hydrobromide; also marketed as generics) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day.
Pfizer pays compensation to families of four children after 15-year legal battle over controversial drug trial in state of Kano
Pfizer was sued after 11 children died in a clinical trial when the northern state of Kano was hit by Africa's worst ever meningitis epidemic in 1996. A hundred children were given an experimental oral antibiotic called Trovan, while a further hundred received ceftriaxone, the "gold-standard" treatment of modern medicine.
Five children died on Trovan and six on ceftriaxone
FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development
Valproate products include: valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.
Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric condition
FDA Drug Safety Communication: Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events
Multaq is used to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted [Refer to Multaq label]
From approval in July 2009 through June 2011, approximately 1 million Multaq prescriptions were dispensed and approximately 241,000 patients received Multaq prescriptions from U.S. outpatient retail pharmacies.2
FDA Drug Safety Communication: Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer
Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), and Skelid (tiludronate).
Osteoporosis drugs - oral bisphosphonates -Commonly used for the prevention and treatment of osteoporosis as well as to treat other bone diseases such as Paget's disease. Osteoporosis is a disease that makes bones weak and more likely to break.
May cause irritation of the esophagus. Irritation of the esophagus can lead to esophagitis (inflammation) or esophageal ulcers (sores), which may bleed. The risk of these esophageal events is low when oral bisphosphonates are prescribed appropriately and the specific directions for use are followed by patients.
FDA Drug Safety Communication: Serious CNS reactions possible when linezolid (Zyvox®) is given to patients taking certain psychiatric medications
Linezolid (Zyvox®) - Used to treat infections, including pneumonia, infections of the skin, and infections caused by a resistant bacterium (Enterococcus faecium). It is a reversible monoamine oxidase inhibitor (MAOI)
FDA Drug Safety Communication: Serious CNS reactions possible when methylene blue is given to patients taking certain psychiatric medications
Methylene Blue - Used to treat methemoglobinemia, vasoplegic syndrome, ifosfamide-induced encephalopathy, cyanide poisoning. It is used as a dye in therapeutic and diagnostic applications. It Is a potent, reversible monoamine oxidase inhibitor (MAOI).
FDA Drug Safety Communication: Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines
Diabetes drugs : Actos (pioglitazone), Actoplus Met (pioglitazone/metformin), Actoplus Met XR (pioglitazone/metformin extended-release), Duetact (pioglitazone/glimepiride) Taking drug for more than one year increased risk of Bladder cancer
FDA Drug Safety Communication:Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants
Antifungal drug Diflucan (fluconazole)
Used to treat yeast infections of the vagina, mouth, throat, esophagus, and other organs.
Used to treat meningitis caused by a certain type of fungus.
Used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before a bone marrow transplant.
The dose of fluconazole for vaginal candidiasis is a single dose of 150 mg and is lower than for other indications.
The Truth About America's Oxy Epidemic
Oxycontin - potent painkiller derived from the poppy flower
Drug Company Profiteering, Pill Mills and Thousands of Addicts: How Oxycontin Has Spread Through America
Oxycontin - potent painkiller derived from the poppy flower
FDA panel: Revoke drug's breast cancer approval
Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and
Potential Risk to Newborns
including Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, Symbyax
The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding
Erythropoiesis-Stimulating Agents (ESAs) in Chronic Kidney disease : Drug Safety
Epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp)
Data shows increased risks of cardiovascular events with ESAs
Increased Incidence of Myelodysplastic Syndrome and Acute Myeloid Leukemia
Following Breast Cancer Treatment with Radiation Alone or Combined with
Chemotherapy: a registry cohort analysis 1990-2005
FDA- Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may
increase the risk of a more serious form of prostate cancer
Drugs in this class are finasteride (marketed as Proscar [finasteride 5 mg] and Propecia [finasteride 1 mg]) and dutasteride (marketed as Avodart). Dutasteride is also available in combination with tamsulosin,
under the brand-name Jalyn
FDA announces new safety recommendations for high-dose simvastatin
Increased risk of muscle injury cited-
Simvastatin is sold under the brand-name Zocor and as a single-ingredient generic product. It is also sold in combination with ezetimibe as Vytorin and in combination with Niacin as Simcor.
Docs on Pharma Payroll Have Blemished Records, Limited Credentials
Drugging Juveniles - Doctors Hired to Evaluate Kids in State Custody have taken
Huge Payments from Drug Companies
Jury orders J&J to pay $10M in Motrin injury case
Motrin - Childrens Fever + Pain Medication
Federal Court Compensated 83 Vaccine-Injured Autistic Children
ADHD: Strattera Death Count Continued - 150 Reports of Deaths, 64 were
Pfizer Did Not Report Chantix Side Effects Correctly?
smoking cessation drug
Another Outrageous Medical Lie
Acetaminophen tied to blood cancers
Tylenol + Paracetamol
American Regent Initiates Nationwide Voluntary Recall of Caffeine & Sodium Benzoate Injection, USP 250 mg/mL, 2 mL Single Dose Vial Due to Visible Particulates
Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin® (Warfarin Sodium) Crystalline 5 mg Tablets, Lot Number 9H49374A
Particles, odors again drive recalls, but origins differ
Cancer treatments, among the highest ranking of drugs in short supply, are now suffering a plague of recalls.
Label-error recalls highlight weak link
Massachusetts House tries to repeal gift ban again
Top 10 Pharma CEO Salaries of 2010
Battle Over Pitching Drugs to Doctors Goes to Supreme Court
New studies point to clot risk of Bayer's Yasmin
Bayer's best-selling contraceptive Yasmin may run a higher risk of dangerous blood clots than those using older birth-control pills
FDA Drug Safety Communication: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine
Crohn’s disease and ulcerative colitis medicines known as tumor necrosis factor (TNF) blockers - azathioprine, and/or mercaptopurine.
SSRI Stories - Antidepressant Nightmares
A list of 4,500 people on antidepressants that have committed horrific acts of violence
Medication-Related Injuries on the Rise
In 2008, 1.9 million people became ill or injured from medication side effects or because they took or were given the wrong type or dose of medication,
FDA : Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse Reactions
New drug for advanced melanoma
FDA - Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies
Revlimid is used to treat a type of blood disorder known as myelodysplastic syndrome. Revlimid is also used along with other drugs to treat people with the cancer known as multiple myeloma
FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures
Benzocaine sprays are marketed under different brand names such as Hurricaine, Cetacaine, Exactacain, and Topex. These sprays are used during medical procedures to numb the mucous membranes of the mouth and throat.
FDA : Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth
Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands - OTC - gels and liquids applied to the gums or mouth to reduce pain
WHO calls for probe of GlaxoSmithKline's swine flu vaccine after reports of narcolepsy
FDA : Citalopram And Finasteride by Greenstone: Recall - Possible Mislabeling
Citalopram (used to treat depression) may contain Finasteride (used for the treatment of benign prostatic hyperplasia). Women who are, or may become pregnant, should not take or handle Finasteride due to the possible risk of side effects which may cause abnormalities to the external genitalia of a developing male fetus.
FDA Drug Safety Communication: Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors
Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Vimovo are available by prescription to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prilosec OTC, Zegerid OTC, and Prevacid 24HR are sold over-the-counter (OTC) for the treatment of frequent heartburn.
Supreme Court Decisions Give Total Liability Shield to Big Drug Companies
HHS Told to Probe "Unethical" Novartis Trials
Indacterol, a Novartis drug for moderate to severe chronic obstructuve pulmonary disease. “The studies were marred by a failure to minimize risk to subjects and inadequate information provided to subjects,”
Flu Vaccine May Have Increased Swine Flu Risk
Designer Drugs Use Out Of Control
US Drug Prices Outstrip Other Medical Costs
Are you Meds Robbing Your Body of Key Nutrients
Drug Giant Accused of Bribing Doctors to Prescribe
FDA - Boxed Warning for Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin hydrochloride), and Avandaryl (rosiglitazone maleate/glimepiride) Tablets
FDA - Black Box Warning - Risk of fluoroquinolone-associated Myasthenia Gravis Exacerbation February 2011 Label Changes for Fluoroquinolones
Avelox tablets+Avelox I.V.,Cipro Tablets, Oral Suspension, IV and Cipro XR tablets,Noroxin Tablets,Levaquin Tablets, Oral Solution and Injection,Proquin XR Extended-Release Tablets,Floxin Tablets,Factive Tablets
60 Lab Studies Now Confirm Cancer Link to a Vaccine You Probably Had as a Child
HHS: 386 injury claims filed over H1N1 countermeasures
Four infants die after vaccination in Gujarat town
The Blind Luck of Cancer Trials
Aluminum-hydroxide in vaccines causes serious health problems
FDA : Serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution
J&J Draws More U.S. Scrutiny on Charges of Violating Laws in Drug Recalls
Ex-chief of KV Pharmaceutical gets month or less in jail
"sending pills across the country that were twice the strength of their labels."
J&J 'lied' about Risperdal's safety, S.C. lawyer alleges
Schizophrenia drug Risperdal
SaneVax Introduces One More Gardasil Girl: Kylie from Arkansas
Revisiting Bone Drugs and Femur Fractures
Osteoporosis Drugs - Fosamax, Actonel and Boniva
A Pinpoint Beam Strays Invisibly, Harming Instead of Healing
Talk Doesn't Pay, So Psychiatry Turns Instead to Drug Therapy
Jury to Hear $1Bln. Lawsuit Against Johnson&Johnson
False Marketing Tactics + schizophrenia drug Risperdal
The American Medical System Is The Leading Cause Of Death And Injury In The United States
FDA : Low magnesium levels can be associated with long-term use of Antacids - Proton Pump Inhibitor drugs (PPIs)
FDA : Safety Review update of Abacavir and possible increased risk of heart attack
Abacavir is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection. Available medications that contain abacavir include Ziagen, Trizivir, and Epzicom
FDA: Risk of oral birth defects in children born to mothers taking topiramate
Migraine Medication Topamax (Topiramate)
Warning: pharmaceutical companies have turned symptoms into diseases
Death by Medicine
The New Child Abuse: The Psychiatric Diagnosing and Drugging of Our Children
Why Doctors Oversell Benefits, Undersell Risks, Side-Effects
When 'Medicine' Makes Things Worse
As Pharmaceutical Use Soars, Drugs Taint Water and Wildlife
Diabetes drug taken by thousands to be pulled from market over safety fears
5 Billion USD the Cost to The Taxpayer of Drug Company Pricing Fraud
How Pharma Bilked the Feds by Selling Vitamins as Prescription Drugs
FDA Approved an Antibiotic Based on Bogus Data - but the Courts Don't Care
Judges Tell Glaxo Sales Reps: You're Just Glorified Coffee Baristas
Nurse Practitioners Like Pharma Lunches and Dinners
Pfizer Will Pay $330M To Settle Prempro Cases
Pfizer Must Pay $1.6 Million Drug Damages, Judges Say
Glaxo Said to Pay $250 Million to Resolve Avandia Suits (Update1
Antipsychotic drugs could shrink patients' brains
FDA: Gardasil approved to prevent anal cancer
FDA Drug Safety Communication: Avandia (rosiglitazone) labels now contain upd