Avandia FDA Review: GlaxoSmithKleine Misinterpreted Drug Study
FDA Reviewer Conlcudes GlaxoSmithKleine Misinterpreted Conclusions Of Avandia Study
The questions surround the safety of the popular drug Avandia (Rosiglitazone) just keep growing.
Friday the most recent news in the FDA's re-examination of the safety af $1.2 billion selling drug Avandia (Rosiglitazone) was released.
A FDA panel concluded that GlaxoSmithKleine was mistaken in its conclusions surround a study that explored the safety of Avandia.
Correctly interpreted, the study actually supports critics’ contentions that Avandia may cause heart attacks, said the reviewer, Dr. Thomas Marciniak, in a posting on the F.D.A.’s Web site.
The company’s misreadings of the study, known as the Record trial, were so profound, he concluded, that they “suggest serious flaws with trial conduct.”
“One does not have to be a mathematician or to perform calculations,” he wrote, to come to the conclusion that a combined look at all the trials of Avandia would demonstrate that it causes heart attacks.
The latest findings from the FDA will be used by a panel next week that is determining if Avandia should be pulled after 11 years of mutli-billion dollar sales on the market.
Meanwhile, the FDA equivalent in Europe the EMA (European Medicines Association) is also reviewing Avandia (Rogsiglitazone)
Dr Tony Hoos, European Medical Director for GlaxoSmithKline said: “GSK is fully committed to patient safety and believes that rosiglitazone is an important treatment option for appropriate Type 2 diabetes patients. It is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients.
Clearly, a lot is at stake - for GlaxoSmithKleine and for the Food and Drug Administration. If Avandia is pulled then the drug manufacturer will be open to massive liability claims and the entire effectiveness of the FDA in keeping consumers safe may well be questioned.