FDA Pulls Diabetes Drug Avandia From U.S. Market
If you are one of the 600,000 Americans who take Avandia, you need to see your doctor right away. That’s only a small fraction of the 24 million of us here who have diabetes, but anyone who now takes it has an important -- and perhaps a life-saving -- decision to make.
The U.S. Food and Drug Administration just pulled the major diabetes drug Avandia (rosiglitazone) from the U.S. market -- with two exceptions. This government agency responsible for drug safety and efficacy says that people with diabetes who are already on Avandia can keep on using it. But the FDA will let us take it only if we and our doctors swear that they have tried every other diabetes drug and that they and their doctors know how risky Avandia is for their heart.The FDA’s decision also affects two drugs that combine Avandia with another drug. These are Avandamet, which is Avandia and metformin, and Avandaryl and glimepiride, one of the sulfonylurea drugs.One study indicates that between when the FDA approved Avandia in 1999 and last year more than 47,000 Americans needlessly suffered heart attacks, strokes, or heart failure -- or died. Still, the FDA’s decision yesterday will let people keep on taking Avandia. And the agency admitted that implementing its decision can take months.
The FDA had previously withdrawn our access to drugs years after the agency approved the them. Think thalidomide, which the FDA approved in the late 1950s and pulled in 1961 after mothers who took it gave birth to many children with tragic birth defects. Think too about the diabetes drug Rezulin, which the FDA approved in 1997 and withdrew 11 years later after about 400 people with diabetes died from liver failure.
Rezulin and Avandia are two of the three drugs in the same class, the thiazolidinediones. The third member of this drug class, Actos, still appears to be safe.
So the FDA’s decision yesterday leaving a loophole was a strange one. Even more unusual was its coordinated announcement with European drug regulators. Well, they coordinated the timing of the announcement, which was highly unusual and perhaps unprecedented. But the European Medicines Agency took Avandia totally off the market there.
The world has a controversial Cleveland Clinic cardiologist to thank. A meta-analysis led by Dr. Steven Nissen that the New England Journal of Medicine published three years ago exposed Avandia’s dangers to people with diabetes.
With the FDA’s action yesterday the second shoe dropped. To mix a metaphor, if you take Avandia the ball is in your court now.
Published On: September 24, 2010