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Consumer Alert: diabetes drug Avandia pulled from the market.

May 24th, 2007 by Todd Hageman

As you know, the wildly popular drug Avandia may be in danger of being pulled from the market by FDA.  Many believe Avandia to be the next Vioxx.  It was mostly reported that Avandia may have presented an unreasonable risk of heart attack and death in patients for which it was prescribed.  As the following link explains, it could also be associated with other cardiovascular injuries including primary pulmonary hypertension (PPH) and congestive heart failure.  The safety of Avandia, and FDA’s ability to monitor drug safety are once again being called into question with many critics stating that FDA’s post-market surveillance for drug safety is inadequate.

Avandia is a trade name for the drug rosiglitazone, which is manufactured by GlaxoSmithKline.  As reported in the New England Journal of Medicine (NEJM), Steven Nissen, M.D. of the Cleveland Clinic conducted an analysis of 42 studies involving more than 15,000 patients.  In Dr. Nissen’s analysis of these studies, Avandia was found to have a 43% greater risk of heart attack and a 64 % increased risk of other cardiovascular deaths as compared to those who only ingested a placebo.  Dr. Nissen concluded, among other things, “serious concerns about the cardiovascular safety of Avandia” are warranted. 

You can read the entire NEJM article here.

Avandia was approved by the FDA in 1999 for the treatment of Type 2 diabetes.  It has been taken by more than 6,000,000 people in the United States and around the world.  In 2006, GlaxoSmithKline reported Avandia sales of $3 billion.  Approximately 1 million Americans may be on Avandia currently.

Everyone should also be aware that Avandia can be combined with other diabetic drugs and sold under the names Avandamet  and Avandaryl.  Both of these drugs contain Avandia.

If you or someone you know has taken Avandia, Avandamet or Avandaryl and suffered from a heart attack or other cardiovascular injury, including congestive heart failure or pulmonary hypertension, I would be happy to speak with you.

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