FDA lacks firm rules on when drug is too risky

Associated Press

WASHINGTON

The arthritis pill Vioxx was withdrawn, but menopause hormones were not, even though both were tied to heart risks. A multiple sclerosis medicine was pulled and later allowed back on.

So, when is a drug too risky to stay on the market?

Drug safety questions arose again this week, as calls mount for the diabetes pill Avandia to be withdrawn. The Food and Drug Administration has no firm rules for deciding such cases — just a murky guideline of “when the risks exceed the benefits.”

The agency does need better criteria for weighing drug safety, he said. It has asked a group of outside scientists, the Institute of Medicine, to give advice. A report is expected before the July 13-14 hearing on Avandia.

Copyright 2010 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.