Access To Justice

GlaxoSmithKline’s diabetes drug Avandia is in the spotlight again.

Confidential government reports say the medication can harm the heart and increase the possibility of heart attacks and heart failure in users, according to a recent New York Times (NYT) article. The Food and Drug Administration (FDA) reports say the drug should be removed from the market, writes the Times.

A Senate report quoted by the Times and released over the weekend says that GlaxoSmithKline (GSK) was aware of  possible cardiac risks associated with Avandia for years before such evidence became public.

The Senate report is the result of a two-year inquiry conducted by Sen. Max Baucus, chairman of the Senate Finance Committee, and Sen. Chuck Grassley, the committee’s ranking Republican. The two senators also asked the FDA to describe the steps it has taken to protect patients in an ongoing Avandia clinical trial since the agency has estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007, according a Senate press release.

GSK issued statements rejecting the conclusions of both the Senate and NYT reports and saying the drug is safe.

Avandia (generic name rosiglitazone) is prescribed to treat Type 2 diabetes. In 2007, the New England Journal of Medicine published a study warning of the possible cardiovascular risk of Avandia. Following the study, the FDA issued a warning about Avandia and GSK relabeled the diabetes medicine to flag the risk of heart failure. However, the FDA has allowed the drug to remain on the market.

As always, do not change medications without first consulting your doctor.