Avandia Liver Failure Side Effects Renew Calls for Recall

New research highlights the potential risk of liver failure from Avandia, renewing calls from the consumer advocacy group Public Citizen for an Avandia recall to be issued by the FDA.

In a report published in the July 22 issue of the peer-reviewed medical journal Pharmacoepidemiology and Drug Safety, Public Citizen researchers looked at reports of Avandia liver failure side effects submitted to the FDA’s Adverse Event Reporting System (AERS) between 1997 and 2006. At least 11 cases of severe liver toxicity were identified among Avandia users, most of which were fatal. Public Citizen indicates these cases are likely only a small fraction of the actual number of liver problems caused by Avandia, as most adverse events are never reported.

Avandia (rosiglitazone) is a type 2 diabetes drug approved by the FDA in 1999. It is a thiazolidinedione agent, which acts by increasing the body’s sensitivity to insulin and aiding in the management of blood sugar in diabetics.

Nearly a dozen studies, including some by Avandia’s manufacturer, GlaxoSmithKline PLC, have indicated that the side effects of Avandia may increase the risk of heart attacks, congestive heart failure, liver failure, bone fractures, macular edema and death. In November 2007, the FDA required that Avandia carry a “black box” warning highlighting the increased risk of heart attacks.

In November 2008, Public Citizen filed a petition with the FDA calling on the agency to ban Avandia, indicating that the number of serious and potentially life-threatening side effects outweigh any potential benefits provided by the diabetes drug. The FDA has not yet taken any action on the petition.

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

Hundreds of Avandia lawsuits have been filed against GlaxoSmithKline PLC alleging injuries caused by the drug. All federal cases have been consolidated into a Multidistrict Litigation (MDL) and centralized in the Eastern District of Pennsylvania before U.S. District Judge Cynthia Rufe, where the first Avandia trials are expected to begin early next summer.