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FDA panel: Vioxx can return to market
Experts voted that Vioxx causes an increased risk of cardiovascular problems, but ok for market.
February 18, 2005: 4:04 PM EST
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GAITHERSBURG, Md. (CNN) - A panel of experts said Friday that Merck & Co. Inc.'s now-withdrawn painkiller Vioxx was safe enough to be sold in the United States despite an increased risk of heart attack and stroke.

Pharmaceutical manufacturer Merck & Co. (up $3.15 to $32.00, Research) said Thursday it could put its painkiller Vioxx back on the market if a federal advisory panel concludes the benefits of the drugs outweigh an increased risk of heart attacks and strokes.

Merck voluntarily withdrew the drug, often used to treat arthritis, in September after studies raised concerns about cardiovascular problems in its users. But studies have linked similar problems to other drugs in the same class as well.

"Since we withdrew Vioxx from the market, the science has continued to evolve and new data on some of these alternative therapies have become available," the company said in a statement issued Thursday afternoon.

Merck's announcement came as an advisory committee of the Food and Drug Administration considered the risks associated with taking Cox II Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which also include the painkillers Celebrex and Bextra.

Dr. Alastair Wood, the head of the panel, said the advisory panel has data on all those drugs that suggests an increased risk of cardiovascular trouble, "and that risk is not trivial."

Vioxx is the only Cox II Selective NSAID to consistently reduce patients' risks of developing gastrointestinal problems resulting from use of the medication. Merck said it has learned new clinical data about other drugs during those proceedings.

"If the advisory committee and the FDA conclude that the benefits of this class outweigh the risks in some patient populations, then we would have to consider the implications of these new data given the unique benefits Vioxx offers," the company said.

Celebrex has remained in the market despite studies indicating similar risk of cardiovascular trouble, while other experts say not enough studies have been done on Bextra to reach a similar conclusion.  Top of page


Merck & Company Incorporated
Food and Drug Administration (FDA)
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