FDA Panel Recommendations Could Be Serious Blow to Avandia

New York, NYIn what could be a serious blow to diabetes drug Avandia, the US Food and Drug Administration (FDA) advisory committee has reportedly overwhelmingly voted that Avandia medication should either be pulled from the market or left on the market with serious label revisions. This is the latest blow to GlaxoSmithKline, which has suffered from criticism that Avandia side effects are more serious than those of other, similar drugs.

The FDA advisory panel met on July 13 and 14, tasked with making recommendations about whether Avandia should be pulled from the market. Avandia has been linked in several studies to an increased risk of heart attacks. The advisory panel had a number of issues to vote on, including whether Avandia had an increased risk of heart attacks over other drugs, whether Avandia had an increased risk of death and whether Avandia should be pulled from the market, left on the market with labeling changes or left on the market as is.

The FDA advisory panel serves an advisory capacity, meaning it makes recommendations to the FDA, but the ultimate decision as to whether or not a drug should be pulled is still left to the FDA.

According to The New York Times (07/14/10), 12 members of the 33-member advisory committee voted to withdraw Avandia from the market, while 10 voted to allow it to stay on the market but with serious label revisions and possible restrictions on sale. Seven members voted to add further warnings while three voted to allow Avandia to be sold as is. One person reportedly abstained in the vote.

Earlier in the day, 18 panel members voted that they were concerned Avandia could cause heart attacks. Nine voted they were not sure if Avandia could cause heart attacks and six voted that they were not concerned about the risk of heart attacks. When asked if Avandia increases the risk of death when compared to older medications, however, one member voted that Avandia increases the risk of death, 20 voted that the risk of death does not increase and 12 voted that they did not know if the risk of death increases with the use of Avandia.

Compared with Actos, seven members voted Avandia has a higher risk of death, 12 voted it does not have a higher risk of death and 14 voted they did not know.

What the panel's recommendations mean for Avandia and GlaxoSmithKline remains to be seen. The FDA will make a final decision about whether to allow Avandia to remain on the market as is, whether to allow it but with strict controls over its labels and sales or whether to withdraw it entirely.