FDA Panel: Keep Avandia on Market
Recommendation Made Despite Concerns That Diabetes Drug Boosts Heart Attack Risk
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Keeping Options Available continued...
But Monday's decision comes after three studies each concluded that Avandia
boosted the risk of heart attacks and other cardiovascular problems by 30% to
40% in patients with type 2 diabetes.
Agency officials said they would now consider warning doctors against
prescribing Avandia in patients with cardiovascular disease, those taking
nitrate drugs for angina, or those with congestive heart failure. Experts and
officials said they also saw strong evidence that patients who have taken
insulin for a long period of time should also avoid the drug.
"These are the people who I think clinicians are going to have to think
twice before they prescribe this medicine," said Rosen, an osteoporosis and
endocrinology expert at the Maine Center for Osteoporosis in Bangor.
A similar drug, Rezulin, was pulled off the U.S. market in March 2000
because of evidence it led to liver toxicity.
An article published in The New England Journal of Medicine in June
rekindled the controversy over Avandia when researchers concluded it spurred a
43% rise in heart attack risk. Widespread reporting of the study caused
many Avandia patients to fear that the drug may cause them more harm than
Experts said they were frustrated by a lack of reliable data clearly showing
which patients are at risk and which may be able to safely use the drug.
Still, there appeared to be significant disagreement within the FDA's
leadership about whether Avandia should remain on the market. Gerald Dal
Pan, MD, the director of the agency's office of surveillance and epidemiology,
announced that he agreed that Avandia should no longer be sold.
It is highly unusual for a senior FDA official to offer an opinion about a
drug's future during expert deliberations. Dal Pan said his statement reflected
"a personal recommendation," and not an official agency position.
But Robert Meyer, MD, director of the FDA's office of new drug evaluation,
said there was "significant disagreement" among regulators over whether
they had enough evidence to act against the drug.
Krall said in a later statement that GlaxoSmithKline was pleased with
Monday's vote. "The committee recognized the debilitating nature of this
disease ad the importance of multiple treatment option."
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