Avandia Update: FDA May Halt Safety Study
By Mike Boyle

Rosiglitazone maleate, better known as GlaxoSmithKline`s (GSK) type 2 diabetes drug Avandia, is back in the news again, as the U.S. Food and Drug Administration is mulling over whether or not it should halt a safety study comparing Avandia to competing drug Actos from rival firm Takeda, according to published reports.

Previous studies have linked Avandia to an increased risk of heart attacks.

You might recall in 2007, the New England Journal of Medicine published an article warning of Avandia`s possible cardiovascular risk. The article triggered the beginnings of a Capitol Hill investigation, and this past February a staff report from the Senate Committee on Finance questioned the drug`s safety and challenged both regulators and the drug maker`s behavior in handling the matter.

In their report, the senators suggested that GSK was aware of the increased cardiac risk but chose not to disclose it. Their report also showed that the FDA itself estimated the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. FDA officials have previously called the clinical trial "unethical and exploitative" of patients. However, other trial investigators see no ethical issues with the trial.

And it has now come to light that FDA Commissioner Margaret Hamburg wrote a letter to legislators in late March saying that the agency was "reassessing the trial."

Read more on the current status of this controversial subject here.

 

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Originally posted April 20, 2010.