US restricts, EU bans controversial diabetes pill

[Hannah Bell]

European regulators ordered the diabetes drug Avandia off the market and the Food and Drug Administration placed stringent restrictions on its use in the United States, saying heart attack risks associated with the former blockbuster are too great a safety concern to continue its use for most people.

In simultaneous news briefings Thursday, the European Medicines Agency and the U.S. Food and Drug Administration announced their long-awaited decisions on the fate of GlaxoSmithKline's controversial drug. The European regulator said it would stop authorizing marketing of Avandia, which will be off the market within the next few months.

The FDA said new patients will be able to get a prescription for Avandia, but only if they can't control their blood sugar with other medications. Doctors will have to document that their patients are eligible to receive the drug and have been briefed on its risks. FDA expects the restricted plan "will limit use of Avandia significantly."

"Rosiglitazone was authorized more than 10 years ago," he said. "Even at that time, there was a question mark over rosiglitazone's cardiovascular safety.

http://news.yahoo.com/s/ap/diabetes_pill_safety;_
several diabetes drugs in the same class previously taken off the market:


Rosiglitazone (Avandia)
Pioglitazone (Actos)
Troglitazone (Rezulin)