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AVANDIA
The United States Food and Drug Administration (FDA) has issued a safety advisory alerting patients about concerns that Avandia, a diabetes drug, has been linked to heart problems. However, it has been revealed that the FDA was aware of the potential increase in risk as early as 2000, a year after GlaxoSmithKline, the drug manufacturer, was approved to market the drug. The FDA is also on record as reprimanding Glaxo for playing down the risks -- again in 2000.
Worldwide sales of Avandia, used to treat Type 2 diabetes, exceeded U.S. $3 billion dollars in the last year alone, making Avandia the company's top seller.
For its part, GlaxoSmithKline alerted the FDA in 2005 and again in 2006 about its own studies that suggested an increased risk for heart attack. Accompanying the report however, was data suggesting that Avandia was no worse, or better than any other drug currently available to treat Type 2 diabetes.
Although the data and communiqués from 2005 and 2006 were posted on-line, they were not shared with the general public, or the medical community. The FDA was silent on the subject until a New England Journal of Medicine paper was made public.
And the doctor who wrote the original letter to the FDA in 2000, Dr. John B. Buse - chief of endocrinology at the University of North Carolina and soon to head up the American Diabetes Association, says that it's too early to pull the drug off the market. He still has concerns, and stands by his findings of seven years ago. However, prudence would dictate that regulators wait until new data is available, he says, from studies now being conducted by GlaxoSmithKline in an effort to isolate the link between Avandia, and increased risk of heart attack.
The manufacturer will be looking to either verify, or dispute Dr. Nissen's findings as published in the NEJM. They suggest that sufferers of Type 2 diabetes present a 20.2 per cent risk of having a heart attack within a 7-year period. However, that risk -- in that time frame -- increases to 28.9 per cent for those patients who use Glaxo's popular diabetic drug.
Six million people in the United States have used Avandia, since it came on the market in 1999.
AVANDIA NEWS
In the wake of the controversy over the diabetes drug Avandia, the U.S. Food and Drug Administration is considering tougher standards for how and when diabetes drugs will be tested for risks to the heart. (Mar-04-08) FORBES: AVANDIA TO STAY ON SHELVES
Even though diabetics who take Avandia are 43% more likely to have a heart attack, the FDA voted 22-1 that its risk/benefit ratio should keep it on drugstore shelves. (Dec-28-07) USA TODAY: AVANDIA TO STAY ON SHELVES
FDA demands that Avandia now carry a black box warning on their label - the highest degree of warning in the FDA's arsenal - for risk of heart attack. (Oct-30-07) DIABETES HEALTH: AVANDIA WARNING
Women taking Avandia, also known as rosiglitazone, had more than twice the chance of suffering fractures than those on generic diabetes pill glyburide. (Sep-19-07) BLOOMBERG: AVANDIA
36 percent of the doctors said they would continue to prescribe Avandia for select patients, 55 percent said they wouldn't prescribe it any more. (Aug-24-07) DIABETES HEALTH: AVANDIA
Food and Drug Administration recommends the agency pull GlaxoSmithKline's diabetes drug Avandia from the U.S. market due to increased cardiovascular risks. (Jul-20-07) MARKETWATCH: AVANDIA CARDIOVASCULAR RISKS
Diabetes drug Avandia, already linked to heart ailments, may get a warning label from U.S. regulators to reflect increased risks of bone fractures, a Morgan Stanley analyst said, citing a new study.
(Jul-04-07) BLOOMBERG: AVANDIA
Avandia - another drug on the market consumed by millions has been found to cause sever risks not noted when cleared by the FDA for sales. (May-26-07) AMERICAN CHRONICLE: AVANDIA RISKS
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