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Group Says Avandia Ups Risk For Liver Damage

Jul 29, 2009 | Parker Waichman Alonso LLP

According to emerging research, GlaxoSmithKline’s diabetes drug, Avandia, can cause death as a result of liver failure, and should be banned by the U.S. Food & Drug Administration (FDA). The group, Public Citizen, published the research in the peer-reviewed medical journal Pharmacoepidemiology and Drug Safety.

According to Public Citizen, it petitioned the FDA to ban Avandia as far back as October due to its risks, including heart attack, heart failure, and liver toxicity, noting that these risks “far outweigh its benefits,” especially given that there are safer medical alternatives for the treatment of Type 2 diabetes. The study discussed 11 cases of severe liver toxicity, mostly fatal, that were associated with Avandia (generic: rosiglitazone) use, said Public Citizen.

Public Citizen identified the 11 cases following review of MedWatch forms submitted to the FDA’s Adverse Event Reporting System (AERS) between 1997 and 2006, it said, noting that such forms are provided to the FDA by patients and health care providers when a suspicion of adverse drug reactions exits. "Because of low reporting rates to the AERS database, the 11 cases likely represent a small fraction of patients who developed liver failure because of the drug," said Dr. James Floyd, a Public Citizen health researcher and lead author of the study, quoted the group. "Our best estimate is that one case of liver failure occurs for every 44,000 patients who take Avandia," Dr. Floyd added.

Last month we wrote about a published Avandia study that found the drug “significantly” raises the risk of heart failure and fractures. Unlike previous research, the study did not find that people taking Avandia were at a higher risk of heart death, and was unable to determine if the Avandia patients in the study had a higher chance of heart attack. According to a report on WebMD, the study—known as RECORD—is causing some controversy because GlaxoSmithKline funded it.

This past October, a Public Citizen working group, with representatives from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes unanimously advised against Avandia. Public Citizen discourages diabetics from taking Avandia because of increased risks for liver toxicity; heart attack (about 40 percent); heart attack and fractures (double); and anemia and vision loss from macular edema; retinal swelling when fluids accumulate in the eye. According to Public Citizen, there were 39 times more reports of macular edema per million prescriptions for Avandia versus the diabetes drug, glipizide.

"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, quoted the group. "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’s cardiovascular side effects have been the subject of concern since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the FDA came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. In November 2007, a warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning.