When is a Drug Too Risky to Stay on the Market?

The painkiller Vioxx has been withdrawn from the market, but menopause hormones are still being sold, even though both were tied to heart risks. A multiple sclerosis medicine was pulled and later allowed back on.

As calls mount for the diabetes pill Avandia to be withdrawn, it has become increasingly apparent that the U.S. Food and Drug Administration has no firm rules for deciding such cases -- only a murky guideline of "when the risks exceed the benefits."

USA Today reports:

“Dr. Joshua Sharfstein, the FDA's principal deputy commissioner ... [said] the agency does need better criteria for weighing drug safety ... It has asked a group of outside scientists, the Institute of Medicine, to give advice.”

The FDA can order a drug off the market, but that decision can be challenged in court. Usually, a company voluntarily withdraws the medicine at the FDA's request.

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