FDA Panel: Keep Avandia on Market
Recommendation Made Despite Concerns That Diabetes Drug Boosts Heart Attack Risk
July 30, 2007 -- An FDA advisory panel said Monday the diabetes drug Avandia
should remain on the U.S. market, despite widespread concerns that it raises
the risk of heart attacks.
Experts overwhelmingly expressed confidence that the drug, also called
rosiglitazone, boosts the risk of heart attack and other dangerous heart
problems. But they then voted 22-1 to urge the FDA to allow continued sales to
But those continued sales are likely to carry significant new warnings about
who can safely use Avandia. Several experts said the FDA should consider either
stark new "black box" warnings on Avandia or other restrictions that
could limit its availability in patients with heart disease.
"We certainly sent I think a clear signal that there's going to be
changes in the way this is promoted ... and certainly in how physicians use this
drug," Clifford Rosen, MD, the panel's leader, said after the decision.
The decision came despite calls from some FDA officials to pull Avandia from
the U.S. market.
"A wrong decision will cost thousands of lives," said David Graham,
MD, an FDA safety officer who urged Avandia be removed.
But officials from GlaxoSmithKline, Avandia's manufacturer, pointed out that
no studies had shown that patients taking Avandia were more likely to die of
heart problems than those taking another drug or a placebo.
"These data tell us that those events aren't resulting in excess
mortality," said Ronald Krall, MD, the company's chief medical officer.
Keeping Options Available
Experts ultimately said they were worried about taking Avandia away as an
option for patients when it is still possible that many may benefit from
"To perform a draconian type of operation on this medication probably
would not be advisable in the long run, said David S. Schade, MD, a professor
of medicine at the University of New Mexico School of Medicine and a member of
the advisory panel.
Avandia is an oral medication used by patients with type 2 diabetes to help
control blood sugar. Millions of patients have taken Avandia, as well as a
similar drug called Actos, or pioglitazone.
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.