FDA asked to pull Glaxo's Avandia

GlaxoSmithKline is circling the wagons around Avandia [1] as leading medical groups began telling doctors not to use the diabetes med. As we reported a couple of days ago, the American Diabetes Association revised its guidelines to privilege older, cheaper drugs, such as the generic metformin, as first-line treatments. But the ADA and the European Association for the Study of Diabetes also said that a joint medical panel "unanimously advised against using" Avandia.

And now, the consumer advocacy group Public Citizen is calling on the FDA to ban the drug, which has been linked with a variety of safety problems, including an increase in the risk of heart attack and stroke. Public Citizen said it has also found 14 cases of liver failure in Avandia patients, 12 of which resulted in death.

FDA told the Wall Street Journal that it will review the petition carefully. As you know, FDA officials have been split over whether to withdraw Avandia or leave it on the market with stronger warnings on its label. GSK, for its part, says it hasn't looked at the Public Citizen petition. "We do not believe there is a connection between liver toxicity and this medicine," the company said, adding that Avandia is safe and effective when used appropriately.

Avandia has lost ground from its once top-selling status since May 2007, when major safety questions first arose. But Public Citizen says that 10,000 scrips are still being filled each day. The drug and a sister combo formula pulled in $313 million in third quarter sales alone.

- read GSK's response [2]
- read the WSJ story [3]

Related Articles:
Docs: Use cheap diabetes meds first [4]
Journal calls for Avandia restrictions [5]
Avandia drop-off erodes GSK profits [6]
FDA mulls tougher standards on diabetes research [7]
Avandia - Top 10 Drug Warnings and Recalls of 2007 [8]