Public Citizen Petitions FDA for Ban Of Avandia
Posted by
Chrissie ColeOctober 31, 2008 10:47 PM
Public Citizen, a non-profit group, is petitioning the U.S. Food and Drug Administration (FDA) for an immediate ban of the drug Avandia because the drug can cause death from liver failure and other serious life-threatening risks that far outweigh its benefits.
Avandia, also known by its generic name, rosiglitazone or rosiglitazone maleate, manufactured by GlaxoSmithKline, is prescribed by doctors for the treatment of type 2 diabetes.
While reviewing FDA data, the group discovered 14 unpublished cases of severe drug-induced liver failure, which included 12 deaths.
That risk, as well as other well known health complications associated with Avandia including heart failure, vision loss and bone fractures, was too great to allow marketing of the drug to continue in the U.S., especially while other, safer treatments remain available, the group said in its petition to the FDA.
“The scientific evidence against Avandia is staggering,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “These findings should give the FDA the push they need to act quickly to prevent any further needless deaths and health damage caused by this drug.”