Pull Controversial Drug from Market, Say Some FDA Staff

July 9, 2010 -- Avandia should be pulled from the market because of the "serious" cardiovascular risk the diabetes drug poses, which exceeds that of competitor Actos, according to some FDA staff reviewers.

Avandia is no more effective at improving glycemic control in type 2 diabetes compared with Actos, and provides no known unique health benefits. While both drugs increase the risk of congestive heart failure, Avandia's effect on CHF is "substantially greater," FDA reviewers wrote in a massive briefing document released Friday.

"Our review of the literature finds no evidence of a unique or meaningful health benefit from rosiglitazone [Avandia] that is not also provided by pioglitazone [Actos] and there is substantial evidence that rosiglitazone increases cardiovascular risk compared with pioglitazone," the reviewers said.

A joint panel of outside medical experts will meet July 13 and 14 to recommend, among other things, whether Avandia should be pulled from the market.

The FDA does not have to follow the advice of its advisory committees, but it usually does.

This will be the second time an advisory panel was tasked with guiding the FDA on what to do about Avandia.

In 2007, a panel voted 20-3 that Avandia increased cardiovascular risk, but then 22-1 that the benefits of Avandia outweigh the risks.

The FDA reviewers blasted the logic in the 2007 decision and said the panel failed to prove what, exactly, the benefits of Avandia were. Since then, the benefits of the drug remain unclarified.

"In the three years since that advisory committee meeting, the Office of New Drugs has not answered the question of what are the unique health benefits of rosiglitazone [Avandia] that have justified its continued marketing," the reviewers wrote. "In our opinion, this approach is inconsistent with public health policy that places patient safety first."

On the RECORD

The briefing document included an analysis of the controversial RECORD trial, which GlaxoSmithKline has leaned on as one of its main defenses on the cardiovascular safety of Avandia.