Regulators Drop the Hammer on Avandia

Patients in the US will only be able to treat their diabetes with GlaxoSmithKiine's Avandia if all other options have been exhausted, and they are made aware of the heart risks associated with the drug.

Concurrently, the European Medicines Agency announced that it would suspend marketing authorization for the drug entirely, concluding that "in view of the restrictions already in place on the use of rosiglitazone, the Committee could not identify additional measures that would reduce the cardiovascular risk."

Avandia has been hounded by detractors ever since publication of a 2007 study by Cleveland Clinic cardiologist Dr. Steven Nissen linking the treatment to an increased risk of heart attacks. Not helping GSK's case was the revelation of internal documents clearly demonstrating that the company was aware of risks to patients' heart health more than a decade ago.

Further, critics questioned the impartiality of GSK's RECORD trial, an in-house study which some allege “excluded deaths among patients taking Avandia from the study that would have shown that the drug increased the risk for heart attacks."

"The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks," said FDA Commissioner Margaret A. Hamburg, MD. "We are seeking to strike the right balance to support clinical care."

While the drug will remain available to patients in the United States, GSK must develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so

"Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research.

Patients in Europe have no such option and "should make an appointment with their doctor to discuss suitable alternative treatments," the EMA said, though they also caution that patients should not stop their current treatments without first seeking medical advice.

Both FDA and EMA rulings apply to rosiglitazone-containing anti-diabetes medicines Avandamet and Avaglim in addition to Avandia.

Around the Web:

European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim [European Medicines Agency]

FDA Significantly Restricts Access to the Diabetes Drug Avandia [Food and Drug Administration]

European Regulator Suspends Glaxo's Diabetes Drugs [Wall Street Journal]

FDA to Severely Restrict the Diabetes Drug Avandia [New York Times]