Vioxx and the FDA

An FDA spokesperson, Kathleen Quinn, said the FDA gets "pressure from all sides - allegations that we're too fast, too slow. We make decisions on the basis of the science. We weigh the benefits against the risks . . . and we make the tough calls."

Vioxx was the first prescription drug since 2001 to be taken off the market for safety reasons.

"No drug is fully safe," Crystal Rice, an FDA spokesperson, said, "Our job is to appropriately balance our decisions, based on the risk-benefit profile for a drug and the societal need and desire for new drugs. We believe that our actions regarding Vioxx were appropriate and consistent with our public health mission."

In Sept. 2001 a paper was published in the Journal of the American Medical Association calling for an investigation into potential heart risks caused by Vioxx. Harvard researchers published a paper in April 2004 indicating an increased heart risk. Cleveland Clinic's top cardiologist, Eric Topol asked the FDA to put a black box label - its most serious warning - on Vioxx. (The FDA did not.)

Doctors are being told to take patients off Vioxx. Please talk to your Doctor as soon as possible about switching to another drug. The FDA has issued a public health advisory, and plans to work closely with Merck to coordinate the withdrawal of Vioxx from the US market.

Lawmakers Question Merck, FDA Over Vioxx

Fri Oct 15, 2004 06:11 PM ET
WASHINGTON (Reuters) - A leading U.S. Senate Republican this week demanded internal documents from Merck & Co. Inc. (MRK.N:) that could answer questions about the company's interaction with U.S. regulators over its arthritis drug Vioxx. [REUTERS]

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