Avandia Linked to Heart Attacks, Liver Failure, Other Health Woes

Date Published: Thursday, October 15th, 2009

The diabetes drug Avandia has been linked to so many health problems that some have questioned whether or not it should be on the market at all.

In November 2007, a warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning. The warning followed an analysis of 42 clinical trails published by the Cleveland Clinic in May 2007 that found patients taking Avandia had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia.

Since then, concerns about Avandia have only grown. In October 2008, the group Public Citizen said it had identified 14 cases of Avandia-induced liver failure in the FDA’s Adverse Event Reporting System. Of the 14 cases of liver failure, 12 resulted in deaths. Those findings prompted Public Citizen to file a petition with the FDA asking that Avandia be removed from the market.

In a press release announcing the petition, Public Citizen encouraged diabetes sufferers to avoid taking the drug because it increases the risk of heart attack approximately 40 percent, doubles the risk of heart failure and bone fractures, and increases the risk of anemia and vision loss from macular edema, a swelling of the retina caused by fluids accumulating in the eye. There were 39 times more reports of macular edema per million prescriptions filled for Avandia than for an older diabetes drug, glipizide, the group said,

Just this past July, Public Citizen published a new study linking Avandia to death resulting from liver failure in the peer-reviewed medical journal Pharmacoepidemiology and Drug Safety. The study discussed 11 cases of severe liver toxicity, mostly fatal, that were associated with Avandia use. The cases were identified after careful analysis of MedWatch forms submitted between 1997 and 2006 to the FDA’s Adverse Event Reporting System (AERS). These forms are submitted to the agency by patients and health-care providers when adverse drug reactions are suspected.

“The research is yet another indication that Avandia is too dangerous to remain on the market,” said Dr. Sidney Wolfe, acting president of Public Citizen, director of Public Citizen’s Health Research Group and co-author of the study. “The FDA’s new leadership should demonstrate its commitment to public health by banning this drug, thereby preventing needless deaths and serious adverse events.”

Avandia was first sold in the U.S. in 1999, and became a blockbuster for GlaxoSmithKline, quickly becoming its biggest selling product. By 2006, Avandia’s total sales were $3.4 billion.

This entry was posted on Thursday, October 15th, 2009 at 11:37 am and is filed under Avandia, Pharmaceuticals.

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