Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin hydrochloride), Avandaryl (rosiglitazone maleate/glimepiride) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research
CONGESTIVE HEART FAILURE See full prescribing information for complete boxed warning. ●Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients (5.1). After initiation of AVANDIA, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of AVANDIA must be considered.
●AVANDIA is not recommended in patients with symptomatic heart failure. Initiation of AVANDIA in patients with established NYHA Class III or IV heart failure is contraindicated. (4, 5.1)
AVANDIA is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)Important Limitations of Use:
•AVANDIA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. (1)
•Coadministration of AVANDIA and insulin is not recommended. (1, 5.1, 5.2)
Source : FDA (05/2014)
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FDA Panel Loosens Noose on Avandia
By David Pittman, Washington Correspondent,
A panel of FDA advisers thinks it is time to ease restrictions on access to Avandia (rosiglitazone), a onetime multimillion dollar blockbuster drug brought low by reports that it increased the risk of heart attacks.
In a combined meeting of separate FDA advisory committees, 20 of 26 panelists voted Thursday to recommend removing or modifying rosiglitazone's highly restrictive label and distribution system. Five voted to keep the product's risk evaluation and mitigation strategy (REMS) as it is now. One panelist voted to remove the product from the market.
Of the 20 panelists who voted to remove or modify the labeling and distribution system, 13 voted to modify it and seven voted to remove the REMS entirely.
The vote of the FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees comes 3 years after the agency placed severe restrictions on the drug following concerns of increased risk of cardiovascular events.
The FDA in its 2010 decision required a re-examination of manufacturer GlaxoSmithKline's (GSK) RECORD trial -- the only large, randomized outcomes trial of rosiglitazone. The trial's method and results were questioned, and re-adjudication results were presented before the panel this week.
Duke Clinical Research Institute (DCRI), the independent reviewer GSK selected for the re-adjudication, found the hazard ratio for cardiovascular death, myocardial infarction (MI), and stroke to be 0.95 (95% CI 0.78-1.17), which is roughly the same as the result of 0.93 (95% CI, 0.74-1.15) from the original study. It was also mostly unchanged from 2010 when breaking down each category individually.
While stroke outcomes were better under rosiglitazone, MI was worse when compared to pioglitazone (Actos).
But the results reaffirming GSK's original findings "moved the needle," as some noted, and helped reassure Thursday's panelists that the drug was no more unsafe than other diabetes products in its class.
"I find no substantial evidence or information that rosiglitazone is unsafe," Arthur Moss, MD, cardiology professor at the University of Rochester School of Medicine in New York, said, adding its ability to lower blood sugar without causing hypoglycemia proves it could be of use.
Sanjay Kaul, MD, director of cardiovascular fellowship training at Cedars-Sinai Medical Center in Los Angeles, said there's not enough evidence to support or blame rosiglitazone's safety and therefore physicians should be able to choose it if they desire.
At the 2010 advisory committee meeting, panelists raised questions about the reliability of the trial's data, its collection, and interpretation. "I no longer have those concerns," said Marvin Konstam, MD, chief physician executive of the Cardiovascular Center at the Tufts Medical Center in Boston.
Other panelists expressed concern with the trial's design. It was open-label and unblinded, opening up the possibility of bias.
Many panelists called for an additional randomized, controlled trial to answer once and for all questions about rosiglitazone's cardiovascular safety. However, such a trial would be difficult given the great amount of publicity rosiglitazone has gained in recent years, they said.
"It may well not be feasible to conduct a trial that answers the questions we have," Susan Heckbert, MD, PhD, epidemiology professor at the University of Washington in Seattle, said.
Moss called for a phase IV study of the 3,400 patients currently taking the drug.
The decision is now in the hands of the FDA. But the FDA has no regulatory deadline by which to make a decision, and it's unclear when the agency will make a ruling, an FDA spokeswoman said.
The FDA isn't obligated to follow the advice of its advisory committees but usually does.
Rosiglitazone-containing products carry the most restrictive type of REMS, that which includes a MedGuide and elements to assure safe use.
Only physicians who hold special certification and certain pharmacies are able to prescribe and dispense the drug. Also, rosiglitazone is limited to patients who are unable to achieve glycemic control on other medications and who are accepting of increased myocardial risks.
Because of the restrictions on prescribing, the number of patients taking the drug has fallen from more than 117,000 at its peak to 3,400 today. Drug regulators in Europe banned the drug altogether because of safety concerns.
The FDA might have options to soften the REMS. For example, the agency could remove certification requirements for pharmacies and prescribers, said Elaine Morrato, DrPH, professor of health systems management and policy at the University of Colorado in Aurora.
At the 2010 FDA panel, 12 of 33 members voted to recommend withdrawing the product from the market completely. Another 10 voted that rosiglitazone should remain available but with added restrictions and a revised label to increase warnings.
Source : Medpage Today
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GlaxoSmithKline to pay $3bn in US drug fraud scandal
GlaxoSmithKline (GSK) is to pay $3bn (£1.9bn) in the largest healthcare fraud settlement in US history.
The drug giant is to plead guilty to promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA).
The settlement will cover criminal fines as well as civil settlements with the federal and state governments.
The case concerns the drugs Paxil, Wellbutrin and Avandia.
Deputy US Attorney General James Cole told a news conference in Washington DC that the settlement was "unprecedented in both size and scope".
Doctors bribed GSK, one of the world's largest healthcare and pharmaceuticals companies, admitted to promoting antidepressants Paxil and Wellbutrin for unapproved uses, including treatment of children and adolescents.
Continue reading the main story “Start Quote We have learnt from the mistakes ”
Andrew Witty GlaxoSmithKline chief executive The illegal practice is known as off-label marketing.
The company also conceded charges that it held back data and made unsupported safety claims over its diabetes drug Avandia.
In addition, GSK has been found guilty of paying kickbacks to doctors.
"The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts," said US attorney Carmin Ortiz.
As part of the settlement, GSK agreed to be monitored by government officials for five years.
GSK said in a statement it would pay the fines through existing cash resources.
Andrew Witty, the firm's chief executive, said procedures for compliance, marketing and selling had been changed at GSK's US unit.
"We have learnt from the mistakes that were made," Mr Witty said. "When necessary, we have removed employees who have engaged in misconduct."
Source BBC News
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Boxed Warning for Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin hydrochloride), and Avandaryl (rosiglitazone maleate/glimepiride) Tablets
BOXED WARNING WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL INFARCTION
- A meta-analysis of 52 clinical trials (mean duration 6 months; 16,995 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with a statistically significant increased risk of myocardial infarction. Three other trials (mean duration 46 months; 14,067 total patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, showed a statistically non-significant increased risk of myocardial infarction and a statistically non-significant decreased risk of death. There have been no clinical trials directly comparing cardiovascular risk of Avandia and Actos (pioglitazone, another thiazolidinedione), but in a separate trial, Actos (when compared to placebo) did not show an increased risk of myocardial infarction or death
- Heart Failure in Observational Studies of Elderly Diabetic Patients Comparing Avandia to Actos ...
- Meta-Analysis of Major Adverse Cardiovascular Events in a Group of 52 Clinical Trials (updated)
- ...Other studies suggest that this risk may also apply to men, although the risk of fracture among women appears higher than that among men.
- The use of Avandia in combination with insulin may increase the risk of myocardial infarction.
Source : FDA (March 2011)
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Diabetes drug taken by thousands to be pulled from market over safety fears
A diabetes drug taken by tens of thousands of people in Britain must be withdrawn from the market because it has been linked with heart problems, a drugs regulator has said.
The European Medicines Agency today recommended that the licence for rosiglitazone, known as Avandia in Britain, should be suspended because the 'benefits no longer outweigh the risks'.
The drug was first licensed ten years ago and restrictions on its use have gradually been added as evidence mounted of links to heart problems.
A spokesman for the Agency said that sufficient evidence had now been accumulated to tip the balance against Avandia.
A parallel evaluation has been ongoing in America, where the Food and Drug Administration recommended that the drug stay on the market but with further restrictions.
A spokesman for the European Medicines Agency said the two organisations used the same data and came to the same conclusions about the risk of the drug but the FDA was not able to order its withdrawal.
It is estimated that patients taking Avandia were between 20 per cent and 40 per cent more likely to suffer heart failure, heart attacks or stroke.
One study had found patients on the drug were 14 per cent more likely to die if they were taking rosiglitazone than on a similar drug.
Patients were urged not to panic and to have their medicines reviewed by their doctor in a 'timely manner'.
Last year there were 500,000 prescriptions dispensed for Avandia in England meaning around 50,000 patients were taking it.
The recommendation from the Agency will be ratified by the European Commission.
Experts in Britain have questioned the regulatory process, licensing of drugs and monitoring of them once they are in use after the episode.
Prof Kent Woods, Chief Executive of the British regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said: "Patient safety is the top priority for the MHRA and we have been constantly monitoring the situation regarding rosiglitazone.
"The suspension means that clinicians should review all patients currently on rosiglitazone and take appropriate action, according to the individual clinical situation, to change to another suitable treatment."
Meanwhile the European Medicines Agency has concluded its review of the swine flu vaccine Pandemrix after there were reports of narcolepsy among some people given the jab.
They found there was insufficient evidence to determine if there is a link or not and further reserach was needed.
Pandemrix and Avandia are both made by GlaxoSmithKline.
Dr Ellen Strahlman, GSK’s Chief Medical Officer, said: “Our primary concern continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients.”
Source: The Telegraph 22/02/2011
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Glaxo Said to Pay $250 Million to Resolve Avandia Suits (Update1
GlaxoSmithKline Plc agreed to pay more than $250 million to resolve about 5,500 claims related to its Avandia diabetes drug and avoid the first trial over claims it can kill users, two people familiar with the accords said.
Glaxo, the U.K.’s biggest drugmaker, agreed to settle the lawsuits claiming the drug causes heart attacks and strokes for an average of at least $46,000 each, said the people, who declined to be identified because they weren’t authorized to speak publicly.
The accords included a previously reported settlement of an undisclosed amount for the family of James Burford, an Avandia user who died in 2006. The Burford family’s case, filed in federal court in Philadelphia, was set for trial last week.
“An average of $46,000 per case is a modest price to pay, in the grand scheme of things,” Gbola Amusa, an analyst at UBS AG in London, said in a telephone interview. “If Avandia definitively had caused heart attacks, Glaxo would have been forced to pay” as much as $1 million a case, he said.
The cases settled were filed by plaintiffs’ lawyers Joseph Zonies and Thomas Cartmell. Glaxo was facing about 2,000 suits alleging the drugmaker hid Avandia’s heart-attack and stroke risks prior to the settlements, lawyers for former users and the company said in court hearings. The company already agreed to pay about $460 million to resolve allegations it didn’t properly warn doctors and consumers about the medicine’s risks.
European Sales Halted
Mary Anne Rhyne, a U.S.-based spokeswoman for Glaxo, declined to comment on the settlements. Zonies, of Denver, and Cartmell, of Kansas City, Missouri, didn’t immediately return calls seeking comment.
The company said Sept. 23 it would stop promoting Avandia worldwide after regulators said the treatment would be withdrawn from the market in Europe and sales would be limited in the U.S. because of studies linking the drug to increased risks of heart attacks.
Avandia sales fell 43 percent to $710 million last year in the wake of the sales restrictions, the company said. Avandia was once the world’s best-selling diabetes pill, generating $3 billion in annual sales.
Glaxo said Jan. 17 it’s taking a $3.5 billion charge to cover expenses linked to investigations and suits over Avandia. The reserve brings to $6.4 billion the amount the drugmaker has set aside in the past year for legal costs tied to Avandia.
GlaxoSmithKline officials said today they’ve updated Avandia’s warning label to include safety restrictions ordered by federal regulators, who cited studies showing the drug poses an increased risk of heart attack and stroke for some users.
The label now warns users that the drug is only intended for consumers who can’t control their blood-sugar levels with other diabetes drugs, according to an e-mailed statement from the company.
Glaxo officials agreed in July to resolve about 10,000 Avandia cases, which they said was the majority of claims over the drug at the time.
Publicity about those accords brought in another wave of suits over the drug, said the people familiar with the settlement of the Zonies and Cartmell cases.
The lawyers were appointed by U.S. District Judge Cynthia Rufe in Philadelphia to lead a group steering the progress of more than 1,600 cases consolidated in that court. London-based Glaxo is facing another 400 claims in state courts across the country, according to a September court filing.
The Zonies and Cartmell settlement included some cases that haven’t yet been filed under an agreement with Glaxo, the people familiar said. Such pacts, known as “tolling agreements,” are common in mass-tort cases.
Trial was slated to begin Jan. 31 in federal court in Philadelphia in the Burford family’s case.
Burford, an electrical-parts salesman, took Avandia for 15 months to treat diabetes before having a fatal heart attack in his North Carolina home, according to court filings. He was 49 at the time of his death.
Glaxo’s American depositary receipts, each representing two ordinary shares, rose 67 cents, or 1.8 percent, to $38.68 at 12:47 p.m. in New York Stock Exchange composite trading. The company rose 18 pence to 1,189 pence in London trading today.
The consolidated case is In re Avandia Marketing, Sales Practices and Products Liability Litigation, 07-01871, U.S. District Court, Eastern District of Pennsylvania (Philadelphia). The Burford case is Deborah Burford v. SmithklineBeecham Corp., 07-CV-05360, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).
Source : Bloomberg
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FDA Drug Safety Communication: Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients
[2-03-2011] The U.S. Food and Drug Administration (FDA) is notifying the public that information on the cardiovascular risks (including heart attack) of the diabetes drug rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 20101 as part of new restrictions for prescribing and use of this drug.
Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).
In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
- In patients already being treated with these medicines
- In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
FDA will be providing further information on this REMS program in the coming months. FDA expects to approve the REMS by Spring 2011, and for the manufacturer to complete implementation 6 months thereafter.
Additional Information for Patients
- You may continue to take a rosiglitazone-containing medicine if directed by your healthcare professional, but it is important that you understand the risks and benefits of the drug.
- Talk to your healthcare professional if you have concerns about rosiglitazone-containing medicines.
- Read the Medication Guide you get along with your rosiglitazone-containing medicine. It explains the risks associated with the use of rosiglitazone.
- Report any side effects from the use of rosiglitazone-containing medicines to the FDA MedWatch program, using the information at the bottom of the page in the "Contact Us" box.
- The REMS for rosiglitazone-containing medicines does not take effect at the time of this announcement. You may continue to prescribe and dispense rosiglitazone-containing medicines as directed in the revised drug label.
- You should begin discussing the risks and benefits of taking rosiglitazone-containing medicines versus other therapies with your patients, and make decisions about optimal treatment for your individual patients.
- Encourage patients to read the rosiglitazone Medication Guide given to them when they pick-up their prescription at the pharmacy
- Report adverse events involving rosiglitazone-containing medicines to the FDA MedWatch program, using the information at the bottom of the page in the "Contact Us" box.
On September 23, 2010, FDA announced that it would significantly restrict the use of rosiglitazone-containing medicines to patients with Type 2 diabetes who cannot control their blood sugar on other medicines. These new restrictions were in response to data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone.
- FDA significantly restricts access to the diabetes drug Avandia2
- Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information3
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Banned in Europe for Causing 83,000 Heart Attacks - Are You Taking it?
A September 23, 2010 article in the New England Journal of Medicine announced that, finally, the FDA has stepped forward and decided on regulatory action for Avandia, a diabetes drug that last year claimed 1,354 lives as a result of cardiac-associated problems. The FDA is restricting access to Avandia by requiring GSK to submit a Risk Evaluation and Mitigation Strategy, or REMS.
Under the ruling, the drug will be available to patients not already taking it only if they are unable to achieve glycemic control using other medications and, in consultation with their health care professional, decide not to take a different drug for medical reasons.
Current users of Avandia will be able to continue using the medication if they appear to be benefiting from it and they acknowledge that they understand these risks. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns.
But did the FDA go far enough – could it be too little, too late?
Unlike the US FDA, British regulators have ruled that GlaxoSmithKline’s diabetes drug Avandia could lead to heart attacks or strokes, and benefits no longer outweigh the risks.
And so last week, they told 90,000 British diabetes patients to stop taking it.
Evidence linking Avandia to an increased risk of a heart attack or stroke has been building since 2007, and GSK has agreed to pay $460 million in damages to settle about 10,000 lawsuits in America linking its use to patients suffering serious medical setbacks. But the US FDA has chosen only to monitor the drug, rather than ask for a recall.
DR. MERCOLA'S COMMENTS:
Like Vioxx, the case of Avandia has turned into yet another classic example of what is fundamentally wrong with the conventional medical paradigm.
Diabetes has increased more than 700 percent in the last 50 years. Today, more than one in four Americans are either pre-diabetic or have full-blown diabetes.
In response, conventional medicine offers up drugs that in no way, shape or form treat the cause of the problem, and worse yet, can prematurely kill many of those who take them.
The drug in question here, rosiglitazone, is sold under the names of Avandia, Avandamet and Avaglim. Avandia alone is used by 2 million people worldwide.
But other diabetic drugs are not necessarily any safer. Two years ago I wrote about Byetta, an “add-on” drug for diabetes (meaning it’s usually prescribed in combination with other drugs) that can cause acute and in some cases lethal pancreatitis.
The saddest part about this debacle is that type 2 diabetes is not only a completely avoidable disease, but also one that in nearly all cases can be successfully reversed without ever touching a drug.
The only thing rosiglitazone drugs like Avandia do is to help lower blood glucose, which has virtually no influence on the long-term damage due to type 2 diabetes. Most of the damage is caused by elevated insulin levels, which can be remedied with an optimal diet and exercise program alone, if you’re compliant.
Another aspect of this story that makes Avandia such a poster child for this lethal paradigm is the fact that GlaxoSmithKline, the manufacturer of Avandia, hid damaging information about the drug for over ten years, as it would adversely affect their sales!
Again and again we are confronted with indisputable evidence that the drug paradigm is about money, not health.
Between 1999 and 2007, Avandia is estimated to have caused 83,000 unnecessary heart attacks. This is a steep price, to say the least, for a disease that does not require drugs to begin with.
This is 20,000 more deaths than Merck caused when they sold Vioxx.
European Medicines Agency Bans Avandia Avandia hit the market in 1999 and quickly became a blockbuster drug. By 2006 its annual revenue was $3.2 billion. By 2009, sales had dropped to $1.2 billion following a damning study published in the New England Journal of Medicine (NEJM) in 2007, which linked Avandia to a 43 percent increased risk of heart attack and a 64 percent higher risk of cardiovascular death than patients treated with other methods.
Unfortunately, a committee of independent experts recommended that Avandia remain on the US market, despite its risks, and an FDA oversight board voted 8 to 7 to accept the advice.
Since that 2007 NEJM study, data from various trials, studies and meta-analyses have consistently confirmed the dangers of this drug, and based on the evidence amassed over the past three years, the European Medicines Agency is now recommending the withdrawal of rosiglitazone-containing diabetic drugs due to the increased risk of ischaemic heart disease.
Their recent press release states that,
“… the Committee could not identify additional measures that would reduce the cardiovascular risk. The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorization of the medicines.
Europe will cease all prescriptions of these drugs within the next few months.
American patients, however, will not receive the same protection from the US FDA.
The September 23, 2010 article in NEJM explains:
“Following an advisory committee meeting held in July 2007, the U.S. Food and Drug Administration (FDA) added information about the possibility of ischemic cardiovascular risk to the drug’s existing boxed warning. At the same time, the FDA also required the sponsors to conduct a head-to-head cardiovascular safety trial of rosiglitazone versus pioglitazone — the other antidiabetic drug in this class available in the United States.
After new data became available, the FDA held a second advisory committee meeting on rosiglitazone safety on July 13 and 14, 2010. On September 23, 2010, the FDA announced regulatory actions stemming from these deliberations.”
The regulatory actions we’ll see in the US includes restricting access to these drugs, but they’re STILL not being taken off the market.
Current users are supposed to be informed of the dangers and sign off that they understand the risks, but can otherwise continue taking it “if they appear to be benefitting from it.” New patients are only supposed to be offered the drug if they’re unable to control their diabetes using some other form of medication.
So, while the European agency determined that there is no way of reducing the cardiovascular risks involved if you’re on this drug, and that its risks outweigh its benefits, the US FDA is still vacillating on this issue.
They seem completely incapable of determining whether or not the lives of tens of thousands of people are more valuable than the corporate profits that feed the agency…
Why is that?
NEJM also points this out, stating that:
“The rosiglitazone controversy is remarkable because there are strongly held, differing positions on how the agency should respond to emerging safety data, both inside the FDA and in the biomedical community.
The 2010 advisory committee was split in advising the agency about what to do. Moving from the least to most restrictive options, 3 members voted to allow continued marketing with no changes to the label; 7 voted that the FDA should adjust the label to account for the new concerns but take no additional action; 10 members voted for the FDA to both increase warnings and limit access to rosiglitazone; and 12 voted that the medication should be removed from the market altogether.
The FDA decided to increase warnings and limit access to rosiglitazone substantially.”
The fact that ANYONE would be callous enough to vote to continue marketing Avandia with little or no change in strategy whatsoever is astounding to me. Yet there were plenty of voices speaking FOR the continuation of insane greed.
That in and of itself speaks volumes about the FDA’s lack of concern for your well-being...
NEJM also hits the nail on its head with the statement that, “the case of rosiglitazone underscores the need for a robust evidence base to demonstrate the safety of medicines administered long-term.”
Amen to that.
But I believe we need to go even further, and re-educate people about their need for such pills in the first place. The drug industry has been able to manipulate the medical industry and most consumers into believing their drugs are the answer to the problem.
Unfortunately, in the vast majority of cases, taking the drug route will lead you further and further away from health, and closer to ever more serious health problems.
Diabetes in particular is a perfect example of a health problem best treated without drugs – if you ever want to get well, that is.
So please understand, you cannot successfully treat the underlying cause of diabetes with drugs!
Most Diabetic Recommendations are DEAD Wrong! And I do mean dead, literally, as they are prematurely killing millions with their flawed insights into basic human physiology.
It’s sad but true – most conventional recommendations for diabetics are seriously flawed and if you follow them, you will likely experience increased health problems and premature death.
First and foremost, you must understand that diabetes is NOT a blood sugar disease like your doctor may have led you to believe. Rather, type 2 diabetes is a disease caused by insulin resistance and faulty leptin signaling, both of which are regulated through your diet.
Listen, the evidence is crystal clear. Regarding Avandia, there is NO REASON for ANYONE to take this drug for diabetes. It has already killed over 80,000 people and does nothing to ameliorate the side effects of diabetes or prevent its complications because it does nothing to address the cause.
It is simply CRIMINAL that this drug is still on the market.
If you or anyone you know is still taking this drug you must warn them of this danger. This is literally a life and death situation. Tell them there are simple, inexpensive, and in many cases free, ways to treat diabetes that actually work and do not kill them.
I discuss these strategies below.
Why You MUST Restrict Fructose Consumption if You Want to Avoid or Treat Diabetes If you want to successfully address your diabetes, or avoid it in the first place, you simply must address your fructose consumption. Your body metabolizes fructose differently from glucose and these differences lead to serious health consequences, one of which is diabetes.
For example, fructose does not stimulate a rise in leptin, so your satiety signals are diminished. It also reduces the amount of leptin crossing your blood-brain barrier by raising triglycerides. And whereas glucose suppresses ghrelin (the hunger hormone, which makes you want more food), fructose does not.
Fructose also increases your insulin levels, interfering with the communication between leptin and your hypothalamus, so your pleasure signals aren’t extinguished. Your brain senses starvation and prompts you to eat more.
All of this also sets the stage for over indulgence and hence overweight, and puts you on the path toward both obesity and diabetes.
I strongly advise keeping your fructose consumption below 25 grams per day.
However, since most people still eat processed foods, it would be wise for most people to limit their fructose to 15 grams or less.
This includes fruits, which also need to be carefully measured to make certain that you’re not inadvertently consuming too much fructose. See the table below to get an idea of how much fructose is in your favorite fruits.
Fruit Serving Size Grams of Fructose Limes 1 medium 0 Lemons 1 medium 0.6 Cranberries 1 cup 0.7 Passion fruit 1 medium 0.9 Prune 1 medium 1.2 Apricot 1 medium 1.3 Guava 2 medium 2.2 Date (Deglet Noor style) 1 medium 2.6 Cantaloupe 1/8 of med. melon 2.8 Raspberries 1 cup 3.0 Clementine 1 medium 3.4 Kiwifruit 1 medium 3.4 Blackberries 1 cup 3.5 Star fruit 1 medium 3.6 Cherries, sweet 10 3.8 Strawberries 1 cup 3.8 Cherries, sour 1 cup 4.0 Pineapple 1 slice
(3.5" x .75") 4.0 Grapefruit, pink or red 1/2 medium 4.3 Fruit Serving Size Grams of Fructose Boysenberries 1 cup 4.6 Tangerine/mandarin orange 1 medium 4.8 Nectarine 1 medium 5.4 Peach 1 medium 5.9 Orange (navel) 1 medium 6.1 Papaya 1/2 medium 6.3 Honeydew 1/8 of med. melon 6.7 Banana 1 medium 7.1 Blueberries 1 cup 7.4 Date (Medjool) 1 medium 7.7 Apple (composite) 1 medium 9.5 Persimmon 1 medium 10.6 Watermelon 1/16 med. melon 11.3 Pear 1 medium 11.8 Raisins 1/4 cup 12.3 Grapes, seedless (green or red) 1 cup 12.4 Mango 1/2 medium 16.2 Apricots, dried 1 cup 16.4 Figs, dried 1 cup 23.0
Clearly, eliminating excess fructose from your diet is far safer and more effective than taking a drug like Avandia if you have diabetes. Unfortunately, most doctors will not tell you this, because they too have been brainwashed by drug- and food industry propaganda. You CAN Cure Diabetes! As I said earlier, type 2 diabetes is virtually 100 percent avoidable and can be effectively treated without medications in about the same percentage of cases by recovering your leptin and insulin sensitivity.
Leptin, a relatively recently discovered hormone produced by fat, tells your body and brain how much energy it has, whether it needs more (saying "be hungry"), whether it should get rid of some (and stop being hungry) and importantly what to do with the energy it has (reproduce, upregulate cellular repair, or not).
In fact, the two most important organs that may determine whether you become (type 2, insulin resistant) diabetic or not are your liver and your brain, and it is their ability to listen to leptin that will determine this.
And guess what...
The only known way to reestablish proper leptin and insulin signaling is through a proper diet and exercise!
There is NO drug that can accomplish this, but following the lifestyle strategies listed below can help you do at least three things that are essential for successfully treating diabetes:
- Recover your insulin/leptin sensitivity
- Help normalize your weight, and
- Naturally normalize your blood pressure
- Severely limit or eliminate sugar and grains in your diet, especially fructose, which is far more detrimental than any other type of sugar.
Finding out your nutritional type will help you do this without much fuss. While nearly all type 2 diabetics need to swap out their grains for other foods, some people will benefit from using protein for the substitution, while others will benefit from using more vegetable-only carbohydrates.
Therefore, along with reducing grains and sugars, determining your nutritional type will give you some insight into what foods you should use to replace the grains and sugars.
- Exercise regularly -- a must for anyone with diabetes or pre-diabetes. Typically, you'll need large amounts of exercise, until you get your blood sugar levels under control. You may need up to an hour or two a day. Naturally, you'll want to gradually work your way up to that amount, based on your current level of fitness.
- Avoid trans fats
- Get plenty of omega-3 fats from a high quality, animal-based source.
- Get enough high-quality sleep every night.
- Optimize your vitamin D levels. Recent studies have revealed that getting enough vitamin D can have a powerful effect on normalizing your blood pressure and that low vitamin D levels may increase your risk of heart disease.
Optimizing your vitamin D levels may also eliminate the risk of type 1 diabetes in your children if you are pregnant. It’s also vital for infants to receive the appropriate amounts of vitamin D in their early years for these same reasons.
Ideally, you’ll want to do this by exposing a large amount of your skin to appropriate amounts of sunshine (or a safe tanning bed) on a regular basis, year-round. Your body can safely create up to 20,000 units of vitamin D a day this way.
However, if neither of these options are available, you may want to use an oral vitamin D3 supplement. But remember, if you choose to take an oral supplement it’s essential that you get your levels tested regularly by a proficient lab to make sure you’re not reaching toxic levels, and are within the therapeutic range. Maintaining your vitamin D levels around 60-80 ng/ml can significantly help control your blood sugar.
- Address any underlying emotional issues and/or stress. Non-invasive tools like the Emotional Freedom Technique (EFT) can be extremely helpful and effective.
- Monitor your fasting insulin level. This is every bit as important as your fasting blood sugar. You'll want your fasting insulin level to be between 2 to 4. The higher your level, the worse your insulin receptor sensitivity is.
SOURCE: Dr. Mercola Oct. 2010
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Diabetes drug still available despite suspension advice
A drug for type two diabetes is still being prescribed in the UK despite being recommended for withdrawal two months ago, BBC Panorama has found.
Avandia has been linked to a raised risk of heart attacks and heart failure and is under a Europe-wide review.
An expert panel of the UK Medicines and Healthcare products Regulatory Agency (MHRA) said its use should be suspended but it is still available on the NHS.
Manufacturer GlaxoSmithKline (GSK) said it was safe if properly monitored.
'Alternative treatments' Tens of thousands of patients take Avandia, also known as Rosiglitazone. It was prescribed more than one million times in the UK last year alone.
Pharmaceutical giant GSK said its research programme proved the drug was "safe and effective when it is prescribed appropriately".
Clinicians at the MHRA's advisory body, the Commission on Human Medicines (CHM), voted unanimously in July for Avandia's withdrawal from the UK. But the recommendation was not made public.
The MHRA said following the advice it sent letters to healthcare professionals asking them to "consider alternative treatments where appropriate".
It also said it used the information to push for a UK withdrawal as part of the Europe-wide review by the European Medicines Agency.
The drug is meant to improve life for type two diabetics by helping to regulate blood sugar levels but there is also evidence it could increase the risk of heart failure and heart attacks.
Swelling "Doctors were advised not to use the tablet in anyone who was at risk of heart failure," said Prof Edwin Gale, a leading UK diabetes expert.
Prof Gale, who chairs the European Medicines Agency scientific advisory group on diabetes, said Avandia should be withdrawn entirely.
"How long do you wait? How important is it to be absolutely certain and at what point do you start saying - this game isn't worth it, people's lives may be at risk, something should be done about it?" he said.
Clinical pharmacologist Dr Yoon Loke, of the University of East Anglia, said his analysis of the class of drug showed that it doubled the risk of heart failure, regardless of whether or not the patients were considered at high risk before they took the drug.
"Even if you restricted it to patients who don't have heart failure, you will still get patients who newly develop heart failure as a result of Avandia," Dr Loke said.
He has calculated that annually in the UK patients could suffer "about 1,000 extra heart attacks and possibly 600 extra cases of heart failure too as a result of using Avandia".
Launched in Europe 10 years ago, Avandia quickly became the market-leading diabetes tablet, earning GSK billions of pounds.
Usha Patel has diabetes and used the drug to manage her condition. But when she developed painful conditions including swelling in her legs and further tests showed that she had developed heart problems, her GP advised her to stop taking Avandia.
"Because of your heart problems, we don't want you to take any more tablets," her GP told her. "Stop it the next day. Don't take it any more."
'First priority' Other patients Panorama spoke to have had a more positive experience with their Avandia prescription.
Helen Lovatt was first prescribed the drug by her GP six years ago and thinks that, together with her recent weight loss, it has helped bring her diabetes under control.
"It suits me, doesn't upset me in any way so if it's not broken why mend it?
"I saw in the paper about the possible side effects, but if my doctor's keeping a good check on me, I'm not going to sit and worry about it," she said.
In response to Panorama's findings, GSK said: "Patient safety is our first priority.
"We have carried out an extensive research programme, involving more than 50,000 patients to analyse the safety and benefits of Avandia and continue to believe it is safe and effective when it is prescribed appropriately."
The Europe-wide review by the European Medicines Agency into Avandia will announce findings whether to restrict its prescription or withdraw it completely later this month.
Panorama: A Risk Worth Taking? is broadcast on BBC One, Monday 6 September at 2030 BST.
Source : BBC News 5/9/2010
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Avandia trial "risky", group claims
An ongoing trial of GlaxoSmithKline's Avandia puts patients' lives at risk and should be stopped immediately, a US pressure group has claimed.
Public Citizen said the diabetes drug, which has been investigated by the Food and Drug Administration (FDA) in the past over allegations it increased the risk of heart attack and chest pain, had an "unfavourable" risk profile and it urged the regulator to bring an end to the test.
Major concerns about Avandia were first raised in 2007. An FDA investigation of the treatment at the time noted its safety risks but decided to keep in on the market.
A later probe into the drug called for a "black box" warning on the product's packaging after a review of 42 studies linked it to an increased likelihood of heart problems.
FDA officials are believed to be taking a closer look at Avandia ahead of their scheduled summer meeting.
A spokesman for Glaxo said the company stood by the treatment.
LINK TO SOURCE
Ongoing review of Avandia and cardiovascular safety
The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible cardiovascular risks with the diabetes drug, Avandia (rosiglitazone).
FDA previously communicated to the public about the possible association between rosiglitazone and increased cardiovascular risk in a2007 safety alert. The agency also sought advice from external experts at the July 30th 2007 joint meeting of the FDA Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. The RECORD study data represent the only new information from a completed randomized, controlled clinical trial of rosiglitazone received by FDA since the 2007 announcements.
The RECORD study was part of a post-approval commitment between the European Medicines Agency (EMA) and the manufacturer. The study was designed to evaluate cardiovascular safety outcomes in 2,220 patients with type 2 diabetes taking rosiglitazone plus metformin or a sulfonylurea compared to 2,227 patients taking metformin and a sulfonylurea. The RECORD study findings were published in the June 2009 issue of Lancet1.
Patients in the study were followed on average 5.5 years and were monitored for the occurrence of the primary endpoint (cardiovascular death and cardiovascular hospitalizations). There were several secondary endpoints including the composite endpoint for major cardiovascular events (cardiovascular death, heart attack or stroke). All cardiovascular endpoints were determined by a team of cardiologists who were unaware of which patients were receiving rosiglitazone.
The study reported no statistically difference in the primary endpoint in the rosiglitazone group compared to combined use of metformin and a sulfonylurea. In addition, there was no significant treatment difference in any of the secondary composite endpoints except for an increase in heart failure, which is a well-known side effect of drugs in this class, including Actos (pioglitazone). The increase in risk of heart failure is consistent with the warnings contained in the current drug label.
FDA is now reviewing the primary data from the completed RECORD study, conducting follow-up audits, and reviewing additional studies. This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time.
In addition to the RECORD study, a number of observational studies of the cardiovascular safety of rosiglitazone have been published. FDA has been reviewing these on an ongoing basis.
The RECORD study was designed to evaluate the cardiovascular safety of rosiglitazone, which is consistent with FDA's December 2008 Guidance for Industry recommending that manufacturers of new treatments for diabetes carefully design their clinical trials to include an evaluation of cardiovascular safety. The RECORD study will be evaluated in the context of this recent Guidance.
Once FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a public Advisory Committee meeting in July 2010. At that meeting, the Advisory Committee will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.
At this time, FDA recommends that healthcare professionals:
- Follow the recommendations in the drug label when prescribing rosiglitazone. This includes a Boxed Warning stating that:
- Use of rosiglitazone in patients with established NYHA Class III or IV heart failure is contraindicated.
- Rosiglitazone is not recommended in patients with symptomatic heart failure.
- Rosiglitazone causes or exacerbates congestive heart failure in some patients, therefore healthcare professionals should monitor for the signs and symptoms of heart failure after starting treatment and after dose increases of rosiglitazone. If heart failure signs and symptoms occur, the heart failure should be managed appropriately and discontinuation or dose reduction of rosiglitazone must be considered.
- Available data on rosiglitazone and risk of myocardial ischemia are inconclusive. A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared rosiglitazone to placebo, found an association between rosiglitazone use and an increased risk of myocardial ischemic events such as angina or heart attack. Three other studies (mean duration 41 months; 14,067 total patients), comparing rosiglitazone to other oral diabetes medications or placebo, have not confirmed or excluded this risk. The recently completed RECORD study, currently being reviewed by FDA, is one of these three studies.
- Discuss with patients the risks of rosiglitazone, taking into account the clinical utility of rosiglitazone, the risks/benefits of other antidiabetic medications, and the risks associated with poorly controlled blood glucose.
- Discuss with patients the importance of adhering to their diabetes medication regimen.
- Report any adverse events associated with the use of rosiglitazone to FDA's MedWatch program at www.fda.gov/medwatch.
GSK Knew Avandia's Risks for Years
A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public.
The report was released on the heels of an article in The New York Times saying that confidential government reports show diabetes patients would suffer 500 fewer heart attacks and 300 fewer cases of heart congestion each month if they took a similar pill named Actos instead of Avandia.
Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee's ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.
Read the Finance Committee Report
CBS News Medical Correspondent Dr. Jennifer Ashton told CBS Radio News that the risks associated with the drug aren't exactly new.
"It should be re-emphasized that in 2007 the FDA issued a black-box warning against Avandia for an increased risk of heart attack and congestive heart failure," Ashton said, "so it's not new that patients who are on this drug or this class of drug should have very involved discussions with their health-care provider about their risks verses the benefits when it comes to taking those medications."
GlaxoSmithKline said in a statement the drug is safe. It said the committee report took data out of context from analyses of Avandia.
In 2007, the FDA ordered a warning to be included on Avandia's label warning that it might increase the risk of heart attacks. But the label also says data on the risks are inconclusive.
CBS NEWS HEALTH
20 February 2010
Staff Report on Glaxosmithkline And The Diabetes Drug Avandia