Q: I have type 2 diabetes, and three years ago I stopped taking Avandia because the Food and Drug Administration labeled it a heart-attack risk. Now it's OK'd by an FDA panel. Is it safe?
JOLENE P., Atlanta
A: Good question. After the drug rosiglitazone (Avandia) was approved for sale in the U.S. in 1999 there were questions about its safety. So the manufacturer asked Duke researchers to conduct the RECORD study. The FDA then had the pharma company arrange with Duke Clinical Research Institute to re-examine that data.
But in the meantime, back in 2007, Dr. Steve Nissen, chair of cardiovascular medicine at the Cleveland Clinic, published a study in the New England Journal of Medicine that raised an alarm. Using the pharma company's own data, he found that Avandia raised the risk of death from heart attack by 43 percent. Because of the public outcry, in 2010 the FDA decided that only specific doctors could prescribe Avandia. In 2012, the pharma company agreed to pay a $3 billion settlement. The medication that once had been prescribed to 117,000 people a year, now is only used by 3,400 Americans and banned completely in Europe.
On June 6, 2013, 20 of 26 panelists on the FDA advisory committee, after getting the results of the new Duke review of the same old study, recommended removing or modifying restrictions on Avandia. And it's highly unlikely that this new review will convince doctors that they can prescribe rosiglitazone safely to most patients. Currently there are safer and more effective treatments.
Mehmet Oz, M.D., is host of "The Dr. Oz Show," and Mike Roizen, M.D., is chief medical officer at the Cleveland Clinic Wellness Institute. Distributed by King Features Syndicate.
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