Avandia and Liver Damage: Who’s Keeping Score?

August 4th, 2009. By janem

Researchers working with Public Citizen must feel like they’re banging their heads against the FDA wall when it comes to Avandia and liver failure. Their recent study of adverse events (called “Case series of liver failure associated with rosiglitazone and pioglitazone” ) reported 11 deaths due to liver toxicity between 1997 and 2006 associated with the use of Avandia. Public Citizen has also been petitioning the FDA since October, 2008, to ban Avandia, saying the drug’s risks outweigh its benefits.

You’re probably thinking that 11 deaths are rather insignificant in the big picture: Public Citizen reported that in 2006, the number of prescriptions filled for the drug peaked at 13.2 million and dropped to 3.1 million in 2008, which means about 8,500 prescriptions a day are still being filled for Avandia.

But those same researchers have pointed out that reporting rates to the FDA are low; most patients who develop liver disease from Avandia likely never report it: They believe 1 in 44,000 patients who take Avandia are at risk for developing liver failure. And Dr. Sidney Wolfe, acting president of Public Citizen, director of Public Citizen’s Health Research Group and co-author of the report, said “The research [on Avandia and liver failure] is yet another indication that Avandia is too dangerous to remain on the market”.

Still, the FDA hasn’t taken this dangerous drug off the market, even though there are safer alternatives. Perhaps the agency is taking into account the manufacturer’s take on all this. According to latimesblogs.com (July 25, 2009), GlaxoSmithKline argues that no scientific study has linked the drug to liver toxicity. After all, 8500 prescriptions a day=cha ching…

Tags: Avandia

This was posted on Tuesday, August 4th, 2009 at 11:57 am and is filed under Emerging Issues . Feel free to respond, or trackback. Read our comments policy.