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The FDA had previously withdrawn our access to drugs years after the agency approved the them.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.