Vioxx

VIOXX PULLED FROM MARKET

Merck & Co., the maker of the arthritis pain reliever VIOXX, has voluntarily removed the drug from the market due to new data showing it increases the risk of heart attack and strokes.

This is one of the largest-ever withdrawals of a drug, says the Food and Drug Administration's Steven Galson. Drugmaker Merck (MRK) says 84 million people worldwide have taken the heavily promoted drug, available in the USA since May 1999. About 2 million Americans are on Vioxx, Galson says. "We have been concerned and aware of the potential for cardiovascular effects for the last few years," he says. "This is not a total surprise."

In August, an FDA-funded analysis involving Kaiser Permanente patients found more heart attacks and sudden cardiac deaths among people taking Vioxx than among those on Celebrex or on conventional nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and aspirin.

In November 2000, Merck published a study in the New England Journal of Medicine that found a higher rate of heart attacks in patients assigned Vioxx than those assigned to naproxen (an NSAID sold as Aleve). Because of that finding, the FDA in April 2002 required a new warning on the Vioxx label.

The implications of the Vioxx withdrawal for other COX-2 inhibitors aren't yet clear. Merck says new data - from a three-year study comparing Vioxx with a placebo in 2,600 patients with colon polyps - showed a higher risk of heart attack and stroke only after 18 months of use. None of the other COX-2 drugs have data for longer than a year, Galson says.

In 2000, Merck spent $160.8 million on direct to consumer Vioxx marketing. Many people are familiar with Vioxx television advertisements featuring famous figure skater Dorothy Hamill. Sid Wolfe, a physician and director of the Health Research Group of the advocacy group Public Citizen in Washington, DC said, "Dorothy Hamill doesn't tell people they have a four times higher risk of a heart attack on Vioxx."

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