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.
We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.
Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones).
Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course (see List of Currently Available FDA-approved Fluoroquinolones for Systemic Use).
Fluoroquinolones are antibiotic medicines that work by killing or stopping the growth of bacteria that can cause illness. They are FDA-approved to prevent or treat certain serious bacterial infections.
The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports* of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone (see Data Summary). We evaluated only reports submitted to FDA, so there are likely additional cases of which we are unaware. The side effects occurred within hours to weeks after starting the fluoroquinolone, and at the time we received the reports, the side effects had continued for an average of 14 months to as long as 9 years after stopping the medicines. Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported the side effects worsened or continued.
We previously communicated about these safety issues associated with fluoroquinolones in May 2016. Additional communications about related safety issues associated with fluoroquinolones occurred in August 2013 (peripheral neuropathy) and July 2008 (tendinitis and tendon rupture). The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.
In addition to updating information in the Boxed Warning, we are also including information about these safety issues in the Warnings and Precautions section of the label. The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI). The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines. We are continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed
Source : FDA (July 2016)
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.
As a result, we are requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. We are continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.
Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations. Patients should talk with your health care professional if you have any questions or concerns.
Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.
Fluoroquinolone drugs work by killing or stopping the growth of bacteria that can cause illness (see List of Currently Available FDA-approved Fluoroquinolones for Systemic Use).
We previously communicated safety information associated with systemic fluoroquinolone antibacterial drugs in August 2013 and July 2008. The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.
We urge patients and health care professionals to report side effects involving fluoroquinolone antibacterial drugs and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
Source : FDA (May 2016)
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.
Children initially given an antibiotic would gain a small amount of weight and then return to their baseline. With more antibiotic prescriptions, however, the gain was cumulative and progressive. As the children aged, the effect of antibiotic prescription on BMI became more pronounced.
Scientists have known for years that antibiotics cause rapid weight gain in animals — they have been a mainstay of industrial farming since the 1950s. More recently, studies have linked their use in newborns and infants to weight gain as well. This is the first study to find that the effects of antibiotics on weight gain are cumulative and persist throughout childhood.
Although the new study did not specifically look at the causes of this weight gain, past research suggests that it might be because the antibiotics we take to eliminate infectious bacteria can also kill off the helpful bacteria in our gut. The microorganisms in our digestive tract help process food; their absence impacts how the body digests and absorbs nutrients and calories, possibly leading to weight gain.
Just how big of an impact do antibiotics have on weight gain in children?
To put the study in perspective, a three-pound weight gain generally translates to less than one BMI point, and it is unlikely that antibiotic use is a major player in the high rates of childhood obesity, a public health epidemic that is likely more due to social and environmental causes than medical ones. But it is possible that these effects have a lifelong impact, and the researchers say they suspect that their reported findings may actually underestimate the true effect of antibiotics on weight gain over a lifetime.
That's partly because information on maternal antibiotic use, a known contributing factor in childhood weight, was not included in the study. There was also no data available for most children prior to age 3, a time when they may be particularly sensitive to the impact of antibiotic use on obesity.
Lead researcher Brian Schwartz emphasized that he expects that the pattern that “the BMI trajectories of children who did and did not receive antibiotics are increasingly diverging at older ages … suggests that the effect likely continues into adulthood.”
The CDC estimates that almost half of antibiotics prescribed in outpatient settings to both children and adults are medically unnecessary. This happens for a variety of reasons, including general lack of understanding as to when antibiotics will actually work as a treatment. Studies like this should encourage judicious antibiotic use and a renewed emphasis on patient education and health literacy. With antibiotic-resistant infections on the rise, researchers say it's time to do away with the “just in case” prescriptions from physicians and the “I want some medicine” demands from patients.
Schwartz explained: “Bottom line: if your doctor tells you that you are your child does not need antibiotics, don’t ask for them. … Eat healthy and your gut microbiota will be very good to you. Don’t change your gut microbiota unnecessarily by taking antibiotics if you don’t need them.”
Source : Washington Post (October 2015)
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.
A person develops diabetes, which is characterized by high blood sugar levels, when the individual cannot produce enough of the hormone insulin or insulin does not work properly to clear sugar from the bloodstream.
More than 29 million Americans have diabetes, according to the Society’s Endocrine Facts and Figures report. Type 2 diabetes, the most common form of the condition, accounts for 90 to 95 percent of all cases.
“In our research, we found people who have Type 2 diabetes used significantly more antibiotics up to 15 years prior to diagnosis compared to healthy controls,” said one of the study’s authors, Kristian Hallundbæk Mikkelsen, MD, of Gentofte Hospital in Hellerup, Denmark. “Although we cannot infer causality from this study, the findings raise the possibility that antibiotics could raise the risk of Type 2 diabetes. Another equally compelling explanation may be that people develop Type 2 diabetes over the course of years and face a greater risk of infection during that time.”
As part of the population-based case-control study, researchers tracked antibiotic prescriptions for 170,504 people who had Type 2 diabetes and for 1.3 million people who did not have diabetes. The researchers identified the subjects using records from three national health registries in Denmark.
People who had Type 2 diabetes filled 0.8 prescriptions a year, on average. The rate was only 0.5 prescriptions a year among the study’s control subjects. Individuals who filled more prescriptions were more likely to be diagnosed with Type 2 diabetes. Many types of antibiotics were associated with a higher risk of diabetes, but there was a stronger link with the use of narrow-spectrum antibiotics such as penicillin V.
Past research has shown that antibiotic treatments can alter the bacteria in an individual’s gut. Studies suggest certain gut bacteria may contribute to the impaired ability to metabolize sugar seen in people with diabetes. This may explain why higher rates of antibiotic use are associated with the development of Type 2 diabetes, but more research is needed to explain the findings, Mikkelsen said.
“Diabetes is one of the greatest challenges facing modern health care, with a globally increasing incidence” he said. “Further investigation into long-term effect of antibiotic use on sugar metabolism and gut bacteria composition could reveal valuable answers about how to address this public health crisis. Patterns in antibiotic use may offer an opportunity to prevent the development of the disease or to diagnose it early.”
Other authors of the study include: Filip K. Knop of the University of Copenhagen; and Morten Frost, Jesper Hallas and Anton Pottegård of the University of Southern Denmark in Odense, Denmark.
The study, “Use of Antibiotics and Risk of Type 2 Diabetes: A Population-based Case-control Study,” was published online at http://press.endocrine.org/doi/10.1210/jc.2015-2696, ahead of print.
Source : Newswise (Aug 2015)
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... In 2010, Bayer's top two fluoroquinolones (Cipro and Avalox) brought in $1 billion in sales.
That same year, Johnson & Johnson sold $1.3 billion-worth of its drug, Levaquin. All antibiotics carry a risk of side effects, but fluoroquinolones are in a class by themselves when it comes to potential health risks.
No other antibiotic carries as high a potential to cause serious, permanent injuries and even death, as the fluoroquinolones do. Despite their higher than normal risks, doctors frequently prescribe them as a first line of treatment even for mild infections. Always ask your doctor if there is a safer alternative.
And, adding insult to injury, most victims claim they were never warned that there are dire adverse effects associated with these antibiotics. I strongly advise you to educate yourself about the risks of fluoroquinolones, and refuse any prescription for these drugs unless absolutely necessary.
What Makes Fluoroquinolones So Dangerous?
Fluoroquinolones have fluoride as a central part of the drug. Fluoride is a known neurotoxin, and drugs with an attached fluoride molecule are able to penetrate into very sensitive tissues, including your brain.
The ability to cross the blood-brain barrier is what makes fluoride such a potent neurotoxin. Fluoride also disrupts collagen synthesis, and can damage your immune system by depleting energy reserves and inhibiting antibody formation in your blood.
According to Todd R. Plumb, M.D.1--a physician and fluoroquinolone victim—fluoroquinolone toxicity appears to be functional, not structural, as structural abnormalities are not typically seen on the radiological studies of patients with fluoroquinolone toxicity. Based on the available research, he cites the following four possible mechanisms of harm by fluoroquinolones:
- Inhibition or disruption of the central nervous system GABA receptors
- Depletion of magnesium and disruption of cellular enzyme function
- Disruption of mitochondrial function and energy production
- Oxidative injury and cellular death
Bitter Pill (click on source to watch) features three victims whose lives have been shattered by the long-term health effects of fluoroquinolones. Placing the blame squarely on the drug maker, one of them says: "[These side effects are] not something they're just finding out now. These people are criminals. They belong in prison for the rest of their lives."
Dr. Terence Young, MD, also featured in this video, lost his 15-year old daughter to a lethal drug effect in 2000.
Channeling his grief into finding out how that could happen, he says he discovered "corrupt practices that prevented doctors and patients learning what the true risks of prescription drugs were. And the reason that's happened is because of this incredible marketing power of the pharmaceutical industry."
Beware the Serious Side Effects of Fluoroquinolones
Last year, the US Food and Drug Administration (FDA) finally issued a warning that fluoroquinolone antibiotics, taken by mouth or injection, carry a risk for permanent peripheral neuropathy.2
Peripheral neuropathy is nerve damage in the arms and/or legs, characterized by "pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain, or temperature, or sense of body position."
But the risk for peripheral neuropathy was noted in 2001, when Dr. Jay Cohen published documentation showing the following fluoroquinolone-related reactions.3 Adverse reactions of fluoroquinolones were documented in Europe as far back as the 1980s:
Nervous system symptoms occurred in 91 percent of patients taking fluoroquinolones (pain, tingling and numbness, dizziness, malaise, weakness, headaches, anxiety and panic, loss of memory, and psychosis) Musculoskeletal symptoms in 73 percent of patients (tendon ruptures, tendonitis, weakness, and joint swelling) Sensory symptoms in 42 percent of patients (tinnitus, altered visual, olfactory, and auditory function) Cardiovascular symptoms in 36 percent of patients (tachycardia, shortness of breath, chest pain, and palpitations) Skin reactions in 29 percent of patients (rashes, hair loss, sweating, and intolerance to heat or cold) Gastrointestinal symptoms in 18 percent of patients (nausea, vomiting, diarrhea, and abdominal pain)In a letter to his Congressman, Dr. Cohen wrote:4
"These severe reactions are occurring in patients who are usually healthy, active, and young. Most often, the antibiotics are prescribed for mild infections such as sinusitis, urinary or prostate infections. Most reactions occur very quickly, sometimes with just a few doses of the fluoroquinolone antibiotic. Reactions are acute, severe, frightening, and often disabling." [Emphasis mine]
Despite persistent warning signs, the FDA didn't take action until 2008, at which point they added a black box warning about severe tendon damage. They waited another five years before issuing a warning about permanent neuropathy.
This is yet another sad example demonstrating that just because a drug is FDA approved does NOT mean it has a proven safety record. Fluoroquinolones have also been associated with the following health problems and adverse effects:5
Retinal detachment, which can cause blindness Disruption of collagen synthesis and collagen degradation,6 causing muscle, tendon, cartilage, and/or ligament damage Nausea and diarrhea Acute kidney failure Hallucinations and/or psychotic reactions. (About one-third of patients tend to experience some sort of negative psychiatric effect, such as anxiety, personality changes, or confusion )Hearing problems Brain fog Painful rashes Disruptions to blood sugar metabolism7 Depression PhototoxicityPeripheral neuropathySeizuresHeart damageAcute liver toxicity8, 9
PLEASE—Only Use Fluoroquinolones as a Last Resort
Dr. Cohen's documentation differs rather drastically with the drug makers' own data. The drug companies claim less than one percent of subjects in clinical trials suffered serious adverse reactions. That's a far cry from Dr. Cohen's data showing a vast majority of patients taking the drugs experience more serious symptoms.
According to Bitter Pill, about 100 Canadian deaths have been attributed to fluoroquinolones since 1985. Freedom of Information documents obtained from the US FDA reveal more than 50,000 reports of adverse reactions and 3,000 deaths. Dr. Young believes the full picture is undoubtedly far worse than that, since most doctors never report suspected drug side effects and/or deaths. Patients also rarely report side effects of drugs they're taking. Previous research suggests that actual reports represent about one percent of the reality.
If your doctor prescribes a fluoroquinolone antibiotic, please be certain that your condition warrants the risks. Fluoroquinolones should really be reserved for treating only the most serious bacterial infections that remain unresponsive to other treatments. While several drugs in this class have been removed from the market due to their deadly adverse effects, six remain FDA-approved for use in the US:
Ciprofloxacin (Cipro )Levofloxacin (Levaquin) Gemifloxacin (Factive) Moxifloxacin (Avelox) Norfloxacin (Noroxin) Ofloxacin (Floxin)
Get Into the Habit of Reporting Adverse Drug Reactions
If you believe you have experienced a reaction to a fluoroquinolone—or any other drug for that matter—please report it to MedWatch, the FDA's safety information and adverse event reporting program. It is vital that they hear from each and every one of you who has experienced an adverse drug reaction. This is a major impetus in getting dangerous drugs removed from the market, and physicians almost never report the reactions themselves so it's really up to you to help make sure dangerous drugs are taken off the market.
Source : Dr. Mercola (November 2014) - click to watch video
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. Pneumonia and influenza together are the eighth leading cause of death and the leading causes of infectious death in the United States. Although clinical practice guidelines recommend combination therapy with macrolides (a class of antibiotics), including azithromycin, as first-line therapy for patients hospitalized with pneumonia, recent research suggests that azithromycin may be associated with increased cardiovascular events, according to background information in the article.
Eric M. Mortensen, M.D., M.Sc., of the VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and colleagues assessed the association of azithromycin use and outcomes within 90 days of hospital admission, including cardiovascular events (heart failure, heart attack, cardiac arrhythmias) and death, for patients 65 years and older who were hospitalized with pneumonia at any Veterans Administration acute care hospital from fiscal years 2002 through 2012.
The final analysis included 31,863 patients who received azithromycin and 31,863 matched patients who did not, but some other guideline-concordant therapy. The researchers found that 90-day mortality was significantly lower in those who received azithromycin (17.4 percent, vs 22.3 percent). There was also an increased odds of heart attack (5.1 percent vs 4.4 percent), but not any cardiac event (43.0 percent vs 42.7 percent), cardiac arrhythmias (25.8 percent vs 26.0 percent), or heart failure (26.3 percent vs 26.2 percent).
“In this national cohort study of veterans hospitalized with pneumonia, azithromycin use was consistently associated with decreased mortality and a slightly increased odds of myocardial infarction,” the authors write. “To put the balance of benefits and harms in context, based on the propensity-matched analysis, the number needed to treat with azithromycin was 21 to prevent 1 death within 90 days, compared with a number needed to harm of 144 for myocardial infarction. This corresponds to a net benefit of around 7 deaths averted for 1 nonfatal myocardial infarction induced.”
“These findings are consistent with a net benefit associated with azithromycin use in patients hospitalized for pneumonia.”
(doi:10.1001/jama.2014.4304; Available pre-embargo to the media at http://media.jamanetwork.com)
Source : Newswise
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FDA Drug Safety Communication: 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.
If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk. Peripheral neuropathy is a nerve disorder occurring in the arms or legs. Symptoms include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position. It can occur at any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped or be permanent. Patients using fluoroquinolones who develop any symptoms of peripheral neuropathy should tell their health care professionals right away.
FDA will continue to evaluate the safety of drugs in the fluoroquinolone class and will communicate with the public again if additional information becomes available.
List of approved fluoroquinolone drug products
Generic name Contained in Brand name
Source : FDA (August 2013)
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FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms
3-12-2013] 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. This communication is a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.The azithromycin drug labels have been updated to strengthen the Warnings and Precautions section with information related to the risk of QT interval prolongation and torsades de pointes, a specific, rare heart rhythm abnormality. Information has also been added regarding the results of a clinical QT study which showed that azithromycin can prolong the QTc interval. (see Data Summary)
Health care professionals should consider the risk of fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events (see Additional Information for Health Care Professionals below). FDA notes that the potential risk of QT prolongation with azithromycin should be placed in appropriate context when choosing an antibacterial drug: Alternative drugs in the macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug.
FDA released a statement on May 17, 2012, about a New England Journal of Medicine (NEJM) study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug.1 The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.
FDA will update health care professionals and the public with any relevant information that becomes available about azithromycin and the risk of abnormal heart rhythms.
Source : FDA (March 2013)
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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, which was led by the University of Southampton and published Online First in The Lancet Infectious Diseases.
"Patients given amoxicillin don't recover much quicker or have significantly fewer symptoms," explains Paul Little, Professor of Primary Care Research at the University of Southampton.
"Indeed, using amoxicillin to treat respiratory infections in patients not suspected of having pneumonia is not likely to help and could be harmful. Overuse of antibiotics, which is dominated by primary care prescribing, particularly when they are ineffective, can lead to side effects such as diarrhea, rash, vomiting and the development of resistance."
LRTI (chest infections) are one of the most common acute illnesses treated in primary care in developed countries. Although viruses are believed to cause most of these infections, whether or not antibiotics are beneficial in the treatment of LRTI, particularly in older patients, is still hotly debated. Research so far has produced conflicting results.
In the study, from the GRACE (Genomics to Combat Resistance against Antibiotics in Community-acquired LRTI in Europe) consortium and funded by the European Community's Sixth Framework Programme, 2061 adults with acute uncomplicated LRTI from primary care practices in 12 European countries (England, Wales, Netherlands, Belgium, Germany, Sweden, France, Italy, Spain, Poland, Slovenia, and Slovakia) were randomly assigned to receive either amoxicillin or a placebo three times a day for seven days. Doctors assessed symptoms at the start of the study and participants completed a daily symptom diary.
Little difference in severity or duration of symptoms was reported between the two groups. This was true even for older patients aged 60 or more who were generally healthy, in whom antibiotics appeared to have a very limited effect.
Although significantly more patients in the placebo group experienced new or worsening symptoms (19.3% vs 15.9%), the number needed to treat was high (30), and just two patients in the placebo group and one in the antibiotic group required hospitalisation.
What is more, patients taking antibiotics reported significantly more side effects including nausea, rash, and diarrhea, than those given placebo (28..7% vs 24%).
Professor Little adds: "Our results show that most people get better on their own. But, given that a small number of patients will benefit from antibiotics the challenge remains to identify these individuals."
Writing in a linked comment, Philipp Schuetz from the University of Basel in Switzerland says: "Little and colleagues have generated convincing data that should encourage physicians in primary care to refrain from antibiotic treatment in low-risk patients in whom pneumonia is not suspected. Whether this one-size-fits-all approach can be further improved remains to be seen. Guidance from measurements of specific blood biomarkers of bacterial infection might help to identify the few individuals who will benefit from antibiotics despite the apparent absence of pneumonia and avoid the toxic effects and costs of those drugs and the development of resistance in the other patients."
Source : Science Daily
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.
Antibiotics are also overprescribed to children in the United States, other experts have said.
The findings were presented Monday at the American College of Chest Physicians (ACCP) annual meeting in Atlanta.
"In our experience, antibiotics are often prescribed by the general practitioner to treat cough in children, many times to pacify parents," study lead author Dr. Francesco de Blasio, of the Clinic Center Private Hospital in Naples, Italy, said in an ACCP news release. "However, antibiotics show very little effectiveness at treating cough due to your average head cold."
It's not hard to understand why this can occur, a U.S. expert noted.
"As parents, it is difficult to watch our children suffering from a terrible cough, but turning to antibiotics is not always the answer," added Dr. Darcy Marciniuk, ACCP president-elect, in the release. "Depending on the underlying cause of the cough, a health care professional can recommend the best treatment options for a child, which, in some cases, may be no treatment."
The study involved 305 children who were treated in their pediatrician's office for a bad cough due to the common cold. Of these kids, 89 were given antibiotics, and 38 received both antibiotics and either an anti-cough medication that affects the central nervous system (codeine, cloperastine) or a "peripheral" medication called levodropropizine.
Meanwhile, 44 children received only an anti-cough drug. The remaining 55 children were not given any treatment.
Although there was no difference in outcomes among the kids taking anti-cough medication alone or with antibiotics, the study revealed the children who were treated with antibiotics alone recovered from their cough more slowly.
The researchers noted that levodropropizine was significantly better in treating the children's cough than centrally acting anti-cough drugs.
"Few drugs are effective as cough suppressants, and antibiotics are no more effective in relieving cough than the use of no medication," de Blasio concluded.
The study authors said that antibiotics are helpful in treating underlying infections that may result in a cough, but they should not be overused.
"Using antibiotics as a treatment for cough without suspected infection is unnecessary and can be harmful," de Blasio said. "Repeated use of antibiotics, especially when they are ineffective, can lead to adverse allergic reactions or a resistance to the medications."
Because this study was presented at a medical meeting, the data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.
SOURCE: Medline Plus VIA American College of Chest Physicians, news release, Oct. 22, 2012
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Study Suggests Early Exposure to Antibiotics May Impact Development, Obesity
Researchers at NYU School of Medicine have made a novel discovery that could have widespread clinical implications, potentially affecting everything from nutrient metabolism to obesity in children. Since the 1950’s, low dose antibiotics have been widely used as growth promoters in the agricultural industry. For decades, livestock growers have employed subtherapeutic antibiotic therapy (STAT), not to fight infection or disease, but to increase weight gain in cattle, swine, sheep, chickens and turkey, among other farm animals.
First author Ilseung Cho, MD, MS, and colleagues set out to reveal how antibiotics were acting on the body to create this effect, hypothesizing that low doses of the drugs may alter the composition and function of the bacteria in the gut. The resulting study, appearing August 22 online ahead of print in Nature, confirmed their theory about the gut microbiome, the term used to refer to the community of bacteria that lives in the stomach, and raises new questions about how manipulating it can impact metabolism and disease in the body.
The researchers administered STAT to normal mice and observed that the mice receiving antibiotics developed increased fat mass and percent body fat. After about six weeks, the mice that received antibiotics had gained about 10 to 15 percent more fat mass than the mice that did not receive antibiotics. The researchers also noted that bone density was significantly increased in STAT mice early in development and that particular hormones related to metabolism were affected by antibiotic exposure, as well.
“By using antibiotics, we found we can actually manipulate the population of bacteria and alter how they metabolize certain nutrients,” said Dr. Cho, assistant professor of medicine and associate program director for the Division of Gastroenterology at the School of Medicine.
“Ultimately, we were able to affect body composition and development in young mice by changing their gut microbiome through this exposure.”
Dr. Cho added that the scientific community is only now beginning to understand just how complex the microbiome is and how it affects health and disease. With a better understanding about the interactions between the microbiome and hosts and how these interactions can be manipulated, he and his colleagues believe the finding has the potential to affect a wide array of conditions ranging from childhood obesity to metabolic syndrome in adults.
Discovered in the early 20th century, antibiotics came into widespread use after World War II with substantial public health benefits. Use of these antibacterial agents has increased dramatically in the years since, now approximating one antibiotic course per year in the average child in the United States. However, there is increasing concern that antibiotic exposure may have long-term consequences, prompting a surge in recent research focused on the effects of antibiotics on development.
“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.”
Dr. Blaser advised that more research is needed to confirm this theory, but that manipulation of the gut microbiome may have implications for other conditions affected by the functions of bacteria in the gut. “We’re still learning how far the impact of the microbiome reaches and the costs of perturbing it,” he said.
Source : Newswise
New Study: Popular Antibiotic Increases Risk of Death
That’s on top of the report that antibiotics in general increase the risk of breast cancer. Azithromycin (marketed as Zithromax) is most often prescribed to treat bronchitis, sinusitis, pneumonia, middle ear infections, and even certain sexually transmitted diseases. It can produce skin rashes, itching, swelling, difficulty breathing or swallowing, and rapid, pounding, or irregular heartbeats. But that’s just the tip of the iceberg.
A study published last Wednesday 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).
Azithromycin belongs to a class of antibiotics called macrolides. A 2008 study published in the British Medical Journal found that when macrolides are combined with cholesterol-lowering statin drugs, the result can be a debilitating muscle weakness called statin-induced myopathy.
This is not the only instance where antibiotics carry great risk. A 2004 study in the Journal of the American Medical Association found that the use of any kind of antibiotics is associated with an increased risk of breast cancer. The more antibiotics the women in the study used, the higher their risk of breast cancer.
Antibiotics are indiscriminate bactericides: they kill the good bacteria that support digestive health and other systems along with the bad bacteria present in an infection. This is why it is important to take a probiotic sometime after using an antibiotic. Probiotics deliver good bacteria directly to the digestive tract without increasing infectious bacteria; they can also reduce the risk of diarrhea, a common side effect of antibiotics.
Like much of allopathic medicine, antibiotics work in opposition to the body’s natural immune system rather than in concert with it, creating new health problems while attempting to treat the original one. This is ironic since the first antibiotics were found in nature, but they were then modified in order to make them new-to-nature and thus patentable.
As we have pointed out in other articles, today’s antibiotics also create resistant supergerms, some of which threaten uncontrollable pandemic. Drug companies, meanwhile, are reluctant to create new antibiotics because of their potential toxicity, the resulting difficulty in getting them approved, and the fact that they are not taken on an ongoing basis like statins and acid blockers and other real money-makers. In this environment, natural antibiotics such as silver and manuka honey, which do not create resistance, are of critical importance, but not being patentable, are spurned both by drug companies and the FDA.
Source : Alliance for Natural Health
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Adverse reactions lead US patients to ask 'just how safe are antibiotics?'
A growing number of American patients say they've been poisoned by fluoroquinolone antibiotics. Not only has this ruined lives, they say, it's exposed the unhealthy relationship between some drug manufacturers and medical regulatory bodies. Carey Purcell reports Bobby Grozier was on top of the world before he took the pills. A senior software adviser for a Fortune 500 company based in Manhattan, he earned a great salary and was happily married with a young daughter.
That changed when he was prescribed a toxic combination of drugs to treat lingering symptoms of what his doctor thought was prostatitis. Ten years later, he suffers from permanent brain damage, is on disability and has lost more than $3 million in medical costs and income.
Grozier was prescribed a combination of ciprofloxacin and vioxx, a nonsteroidal anti-inflammatory drug. Shortly after taking the medicine his ears began to ring. He claims he then called the company that produces ciprofloxacin, Bayer, and reported his symptoms to a pharmacist who told him to keep taking the drug to get the full effect.
Shortly after Grozier stopped taking the prescriptions, he suffered a psychotic episode. He had difficulty breathing, experienced hallucinations, and was barely able to call his mother to ask her to take him to the hospital.
'Things in my ears were resonating like I was in an echo chamber,' Grozier said. 'And everything was wavy…it was unbearable. I really thought I had a heart attack and was dying.'
At the hospital, Grozier was given a sedative. The doctor he spoke with blamed the episode on irritable bowel syndrome, wrote him a prescription for Xanax and sent him home. But his symptoms steadily worsened. He experienced numerous 'petite mal' seizures, was unable to bathe himself and suffered from severe anxiety.
'I was praying to God to take my life, let me die,' Grozier said. 'It was unbearable.' After researching his symptoms online, Grozier concluded that he had been poisoned by the medications his doctor prescribed.
Ciprofloxacin is a fluoroquinolone, an antibiotic used to treat bacterial infections in many different parts of the body. Fluoroquinolones include ciprofloxacin, levofloxacin and levaquin, as well as many other drugs. Fluoroquinolone poisoning is a little-known reaction to the drug.
Symptoms include central nervous system (CNS) toxicity, phototoxicity, cardiotoxicity, arthropathy and tendon rupture. Several fluoroquinolones have been taken off the market due to severe adverse reactions, but these instances are few.
The actual amount of poisonings that occur due to fluoroquinolones is uncertain. Some consider the occurrence to be rare while others say it is far more common than many realise. The lack of recorded cases is due to several factors. Often people do not realise that they have been poisoned, or their doctors do not credit the symptoms to the medication, partly due to the delayed toxicity.
Patients can react to the drugs weeks or months after they are prescribed and patients and doctors do not make a connection between the drugs and the symptoms.
Another reason the condition is often unrecognisable is due to its lack of visible physical symptoms. One victim of the poisoning said it is often referred to as 'the invisible illness,' saying, '[people] look at you and think you’re normal because there’s no open wound or cast…on the inside our nerves are damaged, our tendons are damaged, certain receptors in the brain are not functioning properly.'
Lack of media coverage
While stories about fluoroquinolone poisoning have been published in the Inter Press Service News Agency, the Associated Press and numerous medical journals, the topic is not reported on frequently in the media, and people tend to be skeptical when first learning about it. This lack of knowledge has caused many sufferers to become activists, helping to educate people about the topic. A documentary titled Certain Adverse Events was produced and is available on YouTube.
John Fratti, a former pharmaceutical sales representative, suffered a severe adverse reaction to levaquin in 2005. He has tried to increase awareness of the poisoning, attempting to share knowledge about the drugs’ effects. Fratti claims to possess a Freedom of Information report on levaquin that he requested from the FDA, which reportedly shows there have been 1,015 death outcomes and 14,796 individual safety reports resulting from the drug.
After contacting the Office of Special Health Issues and meeting with FDA officials to discuss the dangers of levaquin, Fratti was hired by the agency, serving part- time as an FDA patient representative for drug safety. Increasing awareness about floroquinolone poisoning is crucial to many patients because doctors are often unaware of the condition and attribute the symptoms to stress, depression or another infection. Many patients communicate with each other online.
Since his poisoning, Bobby Grozier has also reached out to many victims. He has also started a website in order to share information about fluoroquinolone poisoning. Another website founded to support victims of floroquinolone poisoning is www.fqresearch.org, founded by David Fuller. It provides documentation and research about fluoroquinoline poisoning, including legal information about clinical trials.
Fuller took Floxin to treat pneumonia in 1986 and suffered a heart attack and a blow to his Achilles tendon. In the 1990s, he took ciprofloxacin for a sinus infection and has almost completely lost his vision and developed a kidney stone as well as experiencing serious damage to his joints. He diagnosed himself after reading articles online.
'I’m pretty much blind,' he said. 'Prior to this, I didn’t even wear glasses. My hips are going to have to be replaced. My hands are like claws - I can barely bend my fingers. I had to have root canals, and I had teeth break off and fall out of my mouth when I was brushing.'
Furious with the misinformation that had been presented online, Fuller decided to start his own source of information. He launched his website in 2002, and the foundation was started in 2007. A toxicity discussion forum was started in January 2008.
'I’ll be at this until they put me in my grave,' he said of his work. 'Somebody has to do this - trying to get Congress to take a look at this, trying get elected officials to take a look at this… People are literally dying from this drug as we talk.'
Fuller said direct toxicity and DNA damage are two reasons fluoroquinolones are harmful to so many people. 'These drugs change the blueprint by which the replacement cells are made. Now you’ve got defective cells making more defective cells. If the body can recover from it, you’ll get better, but if the damage is so massive the body can’t recover, you’re permanently disabled.'
Anesthesiologist Todd Plumb was prescribed levaquin in 2006. His symptoms included skin burning, profound insomnia and agitation, elevated liver enzymes and numerous issues with his gastrointestinal tract as well as severe numbness and burning pain in his extremities. He described the full onset and progression of neuropathy as similar to what cancer patients experience when going through chemotherapy.
Plumb, who had never heard of fluoroquinolone poisoning during his years as an emergency room doctor and anesthesiologist, went to 15 doctors and spent a week in the Mayo Clinic, attempting to find a diagnosis. He also learned about fluoroquinolone poisoning online.
'You’ll see the same story repeated over and over again,' he said. 'Joint and tendon pain. Tendon rupture. Severe extremity pain. And no one believes them.'
The disbelief, according to Plumb, is due in part to the structure of the US health care system, as doctors are taught to have faith in the medicines they prescribe their patients. 'It’s like losing faith in your religion,' Plumb said. 'I was in their camp before it happened to me. I’d had several people complain to me about problems with cipro. I thought it was a safe medication that worked pretty well. I didn’t want to feel myself that I was doing harm to patients.'
Plumb attributes some of this attitude to studies that are published in medical journals, saying almost every study of a drug shows a beneficial outcome. 'The FDA doesn’t do the research on the drug,' he said. 'The research and development and presentation of that is left to the drug companies themselves...'
He credits this partially to the fact that drug companies purchase advertising in medical journals. 'Every reputable medical journal in America is funded by drug company advertising. Journals wouldn’t get out to doctors unless drugs were advertised in journals.'
'It’s a culture of drug companies holding all the sway,' Plumb continued. 'They pay for everything. Even the way the information is dispersed to physicians. If you look at a journal and count how many pages are drug company advertisements and how many are studies, the drug companies outweigh the studies.'
The FDA maintains the system MedWatch, which is used to report adverse effects to drugs. Manufacturers are required to file a report with MedWatch if a patient reports any reactions to a medication. According to Fuller, the system is severely flawed.
'The FDA throws away 75 per cent of those reports, and the rest go into a database that people can’t access except the FDA,' he said. 'In 1996 they changed over to a different database and everything that happened prior to 1996 you can’t get access to. They pretty much wiped out a history of adverse reactions and gave drug companies a clean slate.'
In 2008, Johnson & Johnson's drug levaquin went on trial for causing tendon damage. Schedin v. Johnson & Johnson was held in federal court in Minneapolis. John Schedin, 82, filed the suit, claiming he ruptured the Achilles tendons in both feet after taking levaquin. He claims Johnson & Johnson and its Ortho-McNeil-Janssen Pharmaceuticals unit did not warn doctors and patients of the drug’s association with tendon damage. Schedin won the case and was awarded damages of $700,000.
This case is the first trial of more than 2,500 claims in U.S. courts alleging that levaquin causes tendon damage, according to advocacy groups. In 2008, the FDA required an upgraded warning on tendon damage posed by levaquin and similar drugs. The black box warning was required for all fluoroquinolones in July 2008.
The warning is a result of the efforts of Public Citizen, a non-profit, consumer rights advocacy group, which filed a lawsuit requiring the warning on the drugs’ packaging and requiring pharmacists to give patients FDA-approved medication guides that also carry the warning.
Conflict of interest for drug approvals
The process of approving a drug for use is fraught with conflict of interest, according to Plumb. In 2007, the FDA issued guidelines barring advisers with more than $50,000 invested in an FDA-regulated drug or medical device company unless they receive a waiver from the agency. People with financial interests of less than $50,000 can participate on the panel but are unable to vote without a waiver from the agency.
'There were no laws against drug company officials physically being on the committee up until a few years ago,' Plumb said. 'The levaquin lawsuit is the tip of the iceberg. It’s a convenient way to mask the other problems it can cause that are more prevalent.'
According to Plumb, the culture of prescriptions in American heath care is in need of examination and possible revision.
'It’s the lesser of two evils,' Plumb said. 'Doctors are making decisions over and over. Medications can cause problems, but they save lives. They take that argument and extend it to say medications don’t usually cause problems, so I’ll give it and hope it doesn’t cause problems. We’re a cultured society that believes that antibiotics in particular are lifesaving and we really need them. Heaven forbid that they are actually causing problems in patients.'
In order to increase awareness about fluoroquinolones, Plumb said many aspects of the system are in need of change, including the education received in medical schools. He said very few continuing education courses have much to do with the pharmacy, and if they do, a doctor presents pharmaceutical research in a positive light.
The presentation of research is also a problem in the sale of pharmaceuticals, according to Fratti. Having once worked as a sales representative, he experienced firsthand the culture of pharmaceutical sales and the influence representatives had on doctors.
'We were trained how to downplay or trivialise doctors’ concerns,' he said. 'We had role-playing sessions, videotaped and graded on how skillful we were able to do that. Pharmaceutical sales are not about educating a doctor. It’s about marketing a doctor and selling the doctor to make sure the doctor sells your drug.'
Fratti also mentioned the gifts that were exchanged between sales representatives and doctors. He gave away $100 gift certificates, free dinners and golf trips.
Doctors’ offices are not the only place where money presents a conflict of interest, according to Plum. He said drug companies provide a large portion of the operating expenses for the FDA in order to have their drugs evaluated.
Sidney Wolfe, M.D., director of Public Citizen's Health Research Group, was quoted in Ivanhoe Medical Breakthroughs as saying user fees, which drug companies pay to the FDA to approve their products, are a key problem in the process of approving drugs. User fees allegedly paid for more than half the drug reviews in 2009 and total more than $600 million of the FDA’s budget.
Fratti has attempted to increase awareness within drug companies, going as far as buying stock in Johnson & Johnson and attending a shareholder convention. During the Q&A session, Fratti spoke to the CEO, board of directors and shareholders, telling them what had happened to him as well as other people who had been injured by levaquin and asking that a warning be put on the package or the leaflet given out by pharmacists. He also requested that further medical research be done by Johnson & Johnson to help people who have been injured and disabled to regain their health.
Fratti is not the first victim of poisoning to buy stock and speak at the convention. Another man who had been poisoned more than 10 years ago also spoke and was given a standing ovation by the shareholders.
'Many of us have contacted Johnson & Johnson and they’re well aware of this, but despite this, they continue to aggressively promote levaquin,' Fratti said.
Long term impacts
The effects of fluoroquinolone poisoning can be short-term, lasting about two years, or lifelong. Grozier and Fratti are both on disability, while Plumb has been able to return to work, but still suffers from the effects of the poisoning.
Fluoroquinolone poisoning has caused financial devastation for some of the patients. Grozier says he knows many other people who have suffered from poisoning and have depleted their savings, lost their homes and are no longer covered by health insurance.
The emotional impact is also difficult to endure. For many patients, there is no external physical evidence of their illness and many people are skeptical, refusing to believe that antibiotics can poison people.
Fratti’s experience has been reported in several media outlets, including ABC news, Harrisburg Patriot News and the documentary Certain Adverse Events. Grozier has also attempted to reach out to the media, sending a packet of information about his experience to numerous media outlets, including Dateline, Oprah, 60 Minutes, Montel Williams and 20/20. His attempts did not result in any coverage.
Fuller wants accountability from the drug corporations and a concerted effort from the US government is necessary, he argues, so Congress should examine what is happening at the FDA. Until changes are put into place at the FDA, people can make an effort to ensure their own safety by researching medications on their own.
'A lot of people think the FDA is out there doing their own rigorous studies on the safety and efficacy of drugs and that’s not the case. They rely on the information supplied to them by pharmaceutical companies,' Fratti said. 'Doctors are fed a lot of propaganda from drug reps, and they are influenced in a way that may not be best for the patients. Patients should not blindly put their trust in doctors. I think patients need to be their own health advocates today and do their own research.'
Source : The Ecologist
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Popular antibiotic ciprofloxacin linked to UK deaths
Millions of us are successfully treated with ciprofloxacin and other fluoroquinolone antibiotics each year. But for some patients the drugs are linked to severe adverse reactions involving terrifying physical and mental health impacts. Andrew Wasley reports Patients who say they’ve suffered severe adverse reactions to a common antibiotic are calling for action to prevent others from experiencing a 'frightening' number of alleged physical and mental side effects.
The victims, who say they were poisoned by ciprofloxacin, want more research into the drug’s side effects, greater education of health professionals and clearer warnings for consumers.
The calls come as an Ecologist investigation revealed the antibiotic has been linked to more than forty deaths in the UK in recent years, and been the subject of hundreds of suspected adverse reactions.
Ciprofloxacin, part of the fluoroquinolone class of antibiotics, is prescribed to treat a range of medical conditions, including bacterial infections. Fluoroquinolones are also – controversially – used to treat diseases in poultry, pig and cattle farming.
Symptoms associated with fluoroquinolone reactions include – according to victims – chronic fatigue, tendonitis, joint pain, muscle weakness and spasms, bladder pain, heart palpitations, depression and anxiety problems, panic attacks, tinnitus, unexplained buzzing and tingling, electric shock-type sensations, insomnia, numbness, impaired vision and sensitivity to light.
Some victims say problems begin immediately after taking the medicine, others weeks or even months later. Some experience minor side effects, others a pattern of debilitating symptoms.
Doctors say however that the percentage of patients who suffer is tiny compared with the overall volume of people successfully treated with the drugs. Millions of prescriptions of ciprofloxacin are administered annually with no reported side effects.
All drugs have to go through a strict testing and licensing procedure in order to be approved, and medicines are constantly reviewed by drug manufacturers. Antibiotics kill bacteria and prevent them from reproducing, and the drugs are credited with saving many lives.
Experts also caution that proving that a drug caused an adverse reaction is fraught with difficulty and point out that possible side effects are clearly listed on prescription medicines.
In the US however, there have been growing calls for fluoroquinolones to be restricted, and manufacturers have been forced to improve warnings on packaging. In 2001 a leading consultant, Dr Jay Cohen, published a groundbreaking if controversial article on the ‘severe and often disabling’ reactions some people sustain whilst taking fluoroquonolones.
Cohen said: ‘It is difficult to describe the severity of these reactions. They are devastating. Many of the people in my study were healthy before their reactions. Some were high intensity athletes. Suddenly they were disabled, in terrible pain, unable to work, walk, or sleep.’
The precise number of US cases is unclear but figures have suggested some fluoroquinolones have generated more than 14,000 adverse reaction reports, and been linked to as many as a 1000 deaths. Public Citizen, which successfully sued the US Food and Drug Administration for clearer warnings and a patient guide, says it took action after around 1,000 individuals suffered tendon rupture after taking fluoroquinolones. Clinical studies have linked the drug to this condition.
Electric shock symptoms
‘I loved life, exercise and movement, my wife, son, friends and work colleagues. Now I am crippled [and] the medical establishment appear to not be able to help me or take me seriously… struggling to keep sane and get through this,’ wrote Geoff Robinson in his diary documenting an apparent adverse reaction to ciprofloxacin.
The 39-year-old, from Sussex, was prescribed the drug last year as a precaution against a suspected urinary infection. The married father of one and fitness enthusiast told the Ecologist he has ‘gone from being uber fit to absolutely crushed with physical and nervous system damage’ after taking the antibiotics last November.
Following a month of unexplained pain in his abdomen and testicles, and after visiting his GP and hospital throughout October, Robinson was prescribed ciprofloxacin ‘just in case’ by a urologist unable to pinpoint the cause of his pain.
Several days after beginning the medication, Robinson found blood in his faeces, developed a mouth ulcer and had inflamed gums, as well as dizziness. In the following days he suffered panic attacks, feelings of disorientation and had growing pains across his perineum, penis and anus.
‘The pain had become unbearable,’ says Robinson, so much so that he had laid on the floor ‘in agony’. At one point ‘I was barely able to walk.’ The next day Robinson began experiencing cold sensations in his feet and calves, pins and needles in his hands, and - he maintains - his wedding ring ‘retracted and moved on its own.’
These symptoms evolved to include burning and crawling sensations on his skin, and an ‘electrical buzz’ type feeling – ‘shocks into eyes, teeth, head, face, legs, feet [and] parts of my body [were] jumping, twitching, spasms so significant [it] made me itch,’ Robinson recalled. He says he experienced an altered heart beat at night, with it feeling ‘very slow then speeding up.’
Just before Christmas Robinson reported pains in his armpits, his lymph gland under his chin became inflamed and he felt ‘pressure' in his head. In February, his ankle joints and shoulder began 'cracking', and his spine and right hip began 'clicking', alongside bouts of tinnitus. He went to hospital eight times – on three occasions in an ambulance. He also paid to see private practitioners. All struggled to diagnose him, despite a multitude of tests.
He was convinced the problems were down to the antibiotics, but several doctors ruled out ciprofloxacin, others were doubtful. One conceded that the antibiotic could have been responsible whilst another – a leading consultant – told him in person that he believed ciprofloxacin was probably to blame, but didn’t confirm this in later correspondence.
Robinson says that other medications he was prescribed alongside ciprofloxacin may have exacerbated the reaction: he was given diclofenac – a non-steroidal anti-inflammatory drug – to take with the antibiotics but chose not to take it until three days after he’d finished the ciprofloxacin. Fluoroquinolones and non-steroidal anti-inflammatory drugs can be a potentially toxic combination, according to some experts. Although his adverse reaction began days before taking the diclofenac it’s possible, he believes, that the anti-inflammatory worsened the symptoms.
Robinson reported his condition, via the Yellow Card scheme, to the Medicines and Healthcare products Regulatory Agency (MHRA) – which oversees drug licensing in the UK – and says they confirmed his symptoms were similar to side effects associated with ciprofloxacin.
Although he has recently carried out some work - he was previously signed off sick – he blames the reaction for putting huge pressure on his mental and physical health.
‘My son is 12 years old and was used to his dad taking him out and generally being very active,’ he says. ‘That’s not been possible.' Robinson says that the toll on his wife has been huge and that it's affected their relationship: ‘I cannot work, I cannot exercise, I cannot drive, which makes day to day trips difficult,’ he says. ‘No alcohol, multiple food allergies, no sex life, sensitivity to sound… it’s miserable.’
Rebecca Smith, 36, from London, describes a similar experience after being prescribed ciprofloxacin to treat a suspected urinary infection in October 2009. She told the Ecologist that her adverse reaction to the antibiotic has ‘limited anything I can do; I used to be very active, hiking [going on] holiday, singing in a choir’ and says that she’s suffered months of poor health.
She initially suffered a panic attack and shaking, experienced sharp pain in both of her heels, buzzing, cold sweats at night, numbness and a tightness in her chest. She also says the reaction has caused the veins in her feet to become much more prominent and for the hairs on her legs to fall out.
Smith was hospitalised for three days after taking the drug: ‘The pain was excruciating and spread; aches and pains in my arms and heels, my toes kept going numb… my GP said this was not side effects [of ciprofloxacin]… they suggested the pain in my heels was because “I was on my feet too much”’.
Seven months after the initial symptoms, Smith suffered a major flare up that she puts down to ‘residual damage’ caused to her nerves, tendons and muscles. She describes clasping a music holder during a concert in which she was singing and felt a burning and tingling in her forearms. Additionally, the backs of her elbows started to hurt. She was suffering from tendonitis, a side effect associated with ciprofloxacin.
‘At A&E they didn’t acknowledge this – [even though] I had mentioned the ciprofloxacin’. Later, Smith says her hands swelled up and went blue as a result of a ruptured tendon in her elbow: ‘I had to sit at home for a week, was off work for three weeks, I couldn’t type,’ she says.
Despite having much of her strength back Smith believes the reaction has weakened her; she had been due to undergo surgery for another condition but was taken off the list after the reaction as 'I couldn't cope with being on the crutches.' She says that even carrying out everyday tasks – like lifting her suitcase when on holiday recently – can still bring on unexpected pains and aches.
Smith says the majority of doctors she dealt with didn’t recognise her symptoms as an adverse reaction, although one said it was ‘possibly ciprofloxacin’.
Others who say they have been poisoned by ciprofloxacin complain that doctors discount – and appear to disbelieve even – that the drug can cause such severe reactions.
‘Apart from the pain of the reaction itself, getting people to listen and consider [ciprofloxacin] as an option is so challenging I almost gave up bothering’, Paul Jones, now recovering after an apparent reaction, recalls. “‘You shouldn’t believe what you read on the internet’ is a typical reply from the doctor, or, “you must listen to your doctor as they are right 99 per cent of the time” is another.’
The 32 year old, from Bristol, lost his job after reacting to a prescription of ciprofloxacin for suspected orchitis. Despite suffering a range of symptoms similar to Robinson and Smith he said his doctor ‘did not want to know’ and admits even trying to convince his family that ciprofloxacin might be responsible was hard.
The patients unanimously believe they were not warned about the possible side effects of ciprofloxacin. Although conceding that notes accompanying the medication do outline reactions they maintain it's the doctors responsibility to educate themselves and pass this info onto patients – and, crucially – to research links when problems are reported.
‘Doctors need to be better educated and shouldn’t be handing out drugs [they] know nothing about,’ says Smith. She believes the medical profession has treated her ‘terribly, it’s terrible when they’ve not listened to you,’ and – whilst acknowledging that there is a need for the drugs – says they should be more restricted.
Robinson argues more research needs carrying out into the side effects of ciprofloxacin and in the meantime says warnings with all fluoroquinolones should be made more prominent, as in the US.
He also says he believes that residues of fluoroquinolines in meat he has consumed may have caused his reactions to flare up significantly, raising concerns over the possible health implications of treating livestock with antibiotics.
Wider pattern of adverse reaction
All three are amongst a larger number of UK patients who have been reported for suspected adverse reactions to ciprofloxacin in recent years; figures obtained by the Ecologist reveal that 1,210 adverse reaction reports relating to the drug were submitted to the MHRA between January 2000 and March 2011. Forty-six deaths in the UK in the same period were also linked to ciprofloxacin.
The figures in turn form part of a wider pattern of adverse reactions to medications, with many people being admitted to hospital each year. A 2004 study by the University of Liverpool suggested that as many as 10,000 patients annually were dying in the UK because of adverse reactions. The researchers stressed the overwhelming majority taking medication do not suffer side-effects.
The researchers estimated – at the time – that adverse reactions were costing the NHS £466 million. More recent research by think-tank Compass put the figure at nearly £2 billion.
As in the US, those who say they suffered adverse reactions to fluoroquinolones believe the true figure is higher, as not everyone affected attributes symptoms to antibiotics, and doctors do not always make the link.
Experts caution however that establishing the precise cause of adverse reactions – and even proving that described symptoms are indeed an adverse drug reaction as opposed to an underlying medical condition – can be difficult.
Jeffrey Aronson, President Emeritus of the British Pharmacological Society, told the Ecologist that ‘only in a very few – and rare – cases [of adverse reactions] can you be sure. In 99.9 per cent of cases you don’t get obvious proof.’
Aronson says there is an assumption that people ‘take a tablet, get an effect’, and therefore that the two are linked. But the reality is that ‘things happen coincidentally, there is a tension here as [drugs] can cause adverse reactions but whether it was directly to blame for specific symptoms, that’s different.’
He said he was aware of tendonitis and tendon rupture being associated with fluoroquinolones.
In a statement to the Ecologist, the MHRA said: ‘All medicines have side effects - no effective medicine is without risk. The priority of the MHRA is to ensure that the benefits of medication outweigh the risks. It is important to note that a report of an adverse drug reaction does not prove that it was caused by the drug. Other factors such as the underlying disease or other medicines may contribute to suspected adverse reactions.’
The body acknowledged that ‘as with any medicine, ciprofloxacin and other fluoroquinolones may cause side effects in some people.’ The MHRA confirmed that it had ‘received 46 reports of suspected side effects with a fatal outcome in association with ciprofloxacin via the Yellow Card Scheme’ between 2000 and the present day, but said ‘whilst such reports may relate to true side effects, they may also be coincidental events due to factors such as underlying or undiagnosed illness or infection.'
‘Such figures must also be considered within the context of the serious infections ciprofloxacin is used to treat, and the number of people treated. For instance, in 2010 alone around 1 million prescriptions for ciprofloxacin were dispensed by community pharmacists in the UK,’ the statement continued.
Does the benefit outweigh the harm?
Aronson says the onus should be on doctors to explain possible side effects of drugs. “‘I’ll look it up” – that would be what would be expected of a good doctor,’ he said. He added the first port of call would ordinarily be a ‘summary of product characteristics’ document, followed by a package insert containing warnings of adverse affects – known as a ‘patient information leaflet’. He also said all doctors have access to the British National Formulary, a database that provides practical information and guidance on the use of medicines, and the Electronic Medicines Compendium.
Claudia Louch, a Harley Street-based natural skin care expert with a background in pharmacology and allergies said it was hard to be certain how widespread recognition of the problem amongst healthcare professionals was.
‘This is difficult to estimate as it depends on what practitioners prescribe to their patients, how this is monitored by the practitioner, as well as symptoms reported to the practitioner by the patient; there are a lot of grey areas, as the patient may have other pre-existing conditions, which may confuse the general picture and terms of symptoms as causing similar types of symptoms in the first instance.’
The MHRA says it believes current drug labelling is adequate, and that the patient information leaflet ‘is a useful basis to aid a discussion between prescribers and patients on the risks and benefits of a medicine’. The body said health care professionals were kept updated with any developments.
Medical experts say that tackling adverse reactions is complex. ‘It’s a case of asking, “what’s the benefit, does it outweigh the harm?,’” says Aronson. He cites the example of someone suffering a headache and someone suffering from cancer: ‘In the case of cancer one might be prepared to [to risk] a severe adverse reaction, with a headache that might not apply.’ He admitted that work to ‘improve prescribing’ needed to be done, as some doctors are ‘not well enough trained in prescribing.’
In the event of a pattern of serious reactions to a specific drug being reported, health officials have a number of options – amendments to labelling, voluntary withdrawal by the medicine’s manufacturer, or a recommendation by the MHRA for the drug’s licence to be withdrawn.
Bayer, manufacturer of ciprofloxacin, declined to respond to the Ecologist.
Source : The Ecologist
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Antibiotics won’t cure sinus infections
“Patients don’t get better faster or have fewer symptoms when they get antibiotics,” says Jay F. Piccirillo, professor of otolaryngology at Washington University in St. Louis and the study’s senior author.
“Our results show that antibiotics aren’t necessary for a basic sinus infection—most people get better on their own.”
.In the United States as many as one in five antibiotic prescriptions are for sinus infections, the authors point out. And given the rise of bacteria resistant to such drugs, they say it is important to find out whether this treatment is effective. Their results show it is not.
“We feel antibiotics are overused in the primary-care setting,” says Jane M. Garbutt, research associate professor of medicine and first author of the paper published in the Journal of the American Medical Association.
“There is a movement afoot, led by the Centers for Disease Control and Prevention, to try to improve the judicious use of antibiotics. We hope this study provides scientific evidence that doctors can use with patients to explain that an antibiotic is not likely to help an acute sinus infection.”
In practice, instead of giving antibiotics, such as the amoxicillin used in this study, the researchers suggest treating symptoms, such as pain, cough, and congestion, along with watchful waiting to see whether further treatment is necessary.
The study included 166 adults whose symptoms fit the criteria for acute sinus infection recommended by an expert panel convened by the Centers for Disease Control and Prevention.
To participate, patients’ symptoms had to be classified as moderate, severe, or very severe. Specifically, they had to report pain or tenderness in the face and sinuses and nasal discharge that lasted between seven and 28 days. Patients with chronic sinus infections or serious complications from the condition, such as a simultaneous ear or chest infection, were not included in the study.
The patients were recruited at their primary-care physicians’ offices in St. Louis and were randomly assigned to receive a 10-day course of either amoxicillin or placebo. Whether on amoxicillin or not, all patients also got medications for relieving pain, fever, congestion, and cough.
The researchers assessed the patients’ symptoms at the start of the treatment and then three, seven, 10, and 28 days afterward. At each time point, patients answered a questionnaire assessing quality-of-life measurements related to the disease called the Sinonasal Outcome Test-16 (SNOT-16). They also compared relapse and recurrence of symptoms and days missed from work.
At day three, they found no difference between the antibiotic and placebo groups in any of these measures. At day seven, a small improvement was seen in the antibiotic group’s questionnaire scores. However, Garbutt says this small change was unlikely to represent a noticeable relief from symptoms.
“On a scale of 1 to 3, we calculated that a clinically significant difference would be a change of 0.5 in the SNOT-16 score,” Garbutt says. “The difference at day seven was 0.19. Even though it was a statistically significant change, it’s likely not a change that a patient would notice.”
Furthermore, this modest statistical improvement disappeared by day ten, when about 80 percent of patients in both groups reported their symptoms were very much improved or cured.
They also found no difference between the antibiotic and placebo groups in the amount of medications patients chose to use to alleviate pain, fever, congestion, and cough.
“It’s a nasty disease,” Garbutt says. “People have significant symptoms. They feel miserable and miss time from work. If an antibiotic is not going to be of any benefit, then what is? That’s a question we haven’t answered yet. But we are working on it.”
Source : Futurity.org
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Gut Biota Never Recover from Antibiotic Use: Loss Extends to Future Generations
Evidence shows the mass antibiotics experiment is devastating our children's health. It may be the reason so many struggle for breath and can't assimilate food properly.
Emerging research shows that the harmful effects of antibiotics go much further than the development of drug resistant diseases. The beneficial bacteria lost to antibiotics, along with disease-inducing bacteria, do not recover fully. Worse, flora lost by a mother is also lost to her babies. The missing beneficial gut bacteria are likely a major factor behind much of the chronic disease experienced today. The continuous use of antibiotics is resulting in each generation experiencing worse health than their parents.
Martin Blaser, the author of a report in the prestigious journal Nature writes:
Antibiotics kill the bacteria we do want, as well as those we don't. These long-term changes to the beneficial bacteria within people's bodies may even increase our susceptibility to infections and disease.
Overuse of antibiotics could be fuelling the dramatic increase in conditions such as obesity, type 1 diabetes, inflammatory bowel disease, allergies and asthma, which have more than doubled in many populations. Aside from the development of superbugs, we're now seeing clear documentation that the overall long term effects of antibiotics are devastatingly harmful to our health. Speaking to ABC News, Blaser said:
Antibiotics are miraculous. They've changed health and medicine over the last 70 years. But when doctors prescribe antibiotics, it is based on the belief that there are no long-term effects. We've seen evidence that suggests antibiotics may permanently change the beneficial bacteria that we're carrying. [Emphasis my own.] Notice that term, permanent. Without considering the potential risks in the casual use of antibiotics, it now looks like conventional medicine is creating several pandemics of some of the worst chronic diseases known.
Mass Use of Antibiotics By the time a child reaches age 18 in the industrialized world, the chances are he or she has been given 10-20 courses of antibiotics. That misuse continues into adulthood, and they're casually prescribed to pregnant women.
That's where the situation grows ever worse. Part of a normal childbirth is a baby's passage through the birth canal—where it's exposed to its first dose of beneficial bacteria. (This should give pause to anyone considering a caesarian birth that isn't absolutely necessary.)
When a mother's microbiota is deficient, her child is born to a deficiency. The evidence now appears to show that, once a probiotic deficiency exists, it is never recovered—and it's passed down the generations. Therefore, each generation is likely to suffer from poorer health than the parents enjoyed.
Costs of Antibiotic-Induced Chronic Conditions Healthcare costs rise and rise in treating this chronic ill health. Consider the pandemic status of diabetes and asthma in children today. Those diseases were extremely rare 50 years ago, and now they're literally routine. Yet, the focus continues to be on treatment—which increasingly lines the pockets of Big Pharma and doctors.
The search for cause has practically been ignored, even in the face of rising rates of chronic illness. Instead, treatment is the touchstone. Ever more toxic methods of suppressing symptoms, while hiding adverse effects, are researched and pushed on conventional medicine's victims.
Two of the most critical functions in health are drastically compromised in enormous numbers of today's children. The ability to metabolize food and the ability to breathe are being stolen from this generation. Yet the treatment they're receiving for this poor health does nothing to make them well. It only masks the symptoms and makes their children even sicker!
On top of those losses, children suffer from allergies, their bodies' inability to distinguish between disease-inducing agents and harmless substances. They suffer from autoimmune disorders, their bodies' inability to distinguish between foreign substances and parts of their own bodies.
Has there ever been a generation of children whose inherent health has been so devastated by the very medical system that is supposedly responsible for their health?
Iatrogenic Disease Iatrogenic disorders are health problems caused by medical errors. They are now officially the third-leading cause of death in the United States. But those numbers do not include early deaths from diabetes, asthma, allergies, chronic bowel disorders, or cancer—all of which have been documented as results of antibiotic use—nor are the miseries suffered by the people burdened with them reckoned in the iatrogenic toll.
If we were to add all those early deaths to the iatrogenesis numbers, as should be done, it would be obvious that conventional medicine is the greatest killer and thief of health the world has ever known. And apparently, one of the most significant causes of iatrogenic illness is antibiotics, that most common of treatments handed out like candy.
Source Gaia Health
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Risk of fluoroquinolone-associated Myasthenia Gravis Exacerbation February 2011 Label Changes for Fluoroquinolones
(a group of antibiotics which exert their antimicrobial effects by inhibiting bacterial DNA gyrase. They are effective primarily against gram-negative organisms)
Avelox (moxifloxacin hydrochloride) tablets and Avelox (moxifloxacin hydrochloride in NaCl injection) I.V.4
* Exacerbation of myasthenia gravis
Cipro (ciprofloxacin hydrochloride) Tablets, Oral Suspension, IV and Cipro XR (ciprofloxacin extended-release tablets)5
* Exacerbation of myasthenia gravis
Factive (gemifloxacin mesylate) Tablets6
* Exacerbation of myasthenia gravis
Floxin (ofloxacin) Tablets7
* Exacerbation of myasthenia gravis
Levaquin (levofloxacin) Tablets, Oral Solution and Injection8
* Exacerbation of myasthenia gravis
Noroxin (norfloxacin) Tablets 9
* Exacerbation of myasthenia gravis
Proquin XR (ciprofloxacin) Extended-Release Tablets10
* Exacerbation of myasthenia gravis
- Avelox (moxifloxacin hydrochloride) tablets and Avelox (moxifloxacin hydrochloride in NaCl injection) I.V.
- Cipro (ciprofloxacin hydrochloride) Tablets, Oral Suspension, IV and Cipro XR (ciprofloxacin extended-release tablets)
- Noroxin (norfloxacin) Tablets
- Levaquin (levofloxacin) Tablets, Oral Solution and Injection
- Proquin XR (ciprofloxacin) Extended-Release Tablets
- Floxin (ofloxacin) Tablets
- Factive (gemifloxacin mesylate) Tablets
- Fluoroquinolone products may exacerbate muscle weakness in persons with myasthenia gravis. Avoid fluoroquinolone products in patients with known history of myasthenia gravis
- Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid fluoroquinolones in patients with known history of myasthenia gravis.
- Exacerbation of myasthenia gravis
What is the most important information I should know?
- Worsening of myasthenia gravis (a disease which causes muscle weakness). Fluoroquinolones may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
- Tell your healthcare provider about all your medical conditions, including if you have a disease that causes muscle weakness (myasthenia gravis).
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Increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline)
[09-01-2010] The U.S. Food and Drug Administration (FDA) is reminding healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was determined using a pooled analysis of clinical trials. The cause of the excess death in these trials is often uncertain, but it is likely that most deaths in patients with these severe infections were related to progression of the infection.
The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. Tygacil is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia) or diabetic foot infection. Tygacil is approved by FDA for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia.
FDA has updated the Warnings and Precautions and Adverse Reactions sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil. Healthcare professionals have also been informed of this increased risk via a Dear Health Care Professional letter.
Additional Information for Healthcare Professionals
- The greatest increase in risk of death with Tygacil was seen in patients with ventilator-associated pneumonia, an unapproved use.
- Alternatives to Tygacil should be considered in patients with severe infections.
- Report adverse events involving Tygacil to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.
The pooled analysis grouped 13 trials with patients given Tygacil for both approved and unapproved indications by type of infection (see Table below), comparing the overall mortality for Tygacil vs. pooled control agents. Overall, in the trials, death occurred in 4.0% (150/3788) of patients receiving Tygacil and 3.0% (110/3646) of patients receiving comparator antibiotics. An adjusted risk difference for all-cause mortality based on a random effects model stratified by trial weight was 0.6% (95% CI 0.1, 1.2) between Tygacil and comparator treated patients.
Although for each indication, the mortality difference was not statistically significant, mortality in Tygacil treated patients was numerically greater in every infection, sometimes considerably greater, particularly in ventilator-associated pneumonia. Tygacil is not approved for ventilator associated pneumonia because of an unacceptably low cure rate, as well as excess mortality.
As stated in general, Tygacil is considered bacteriostatic; however, it has demonstrated bactericidal activity against isolates of S. pneumoniae and L. pneumophila. One possible reason for the mortality difference is that in certain severe infections, Tygacil's bacteriostatic mechanism may put it at some disadvantage, although for approved indications, cure rates with Tygacil were generally similar to that seen with the bactericidal active control agents.
Source : FDA 1/09/2010
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