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FDA ORDERS PFIZER'S BEXTRA WITHDRAWN

Cites 'Unfavorable' Risk vs. Benefits

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DETROIT (AdAge.com) -- The Food and Drug Administration last night asked Pfizer to withdraw its arthritis medication Bextra from the market, saying the "overall risk versus benefit profile for the drug is unfavorable."
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The move was part of a series of sweeping changes announced by the FDA that pertain to the COX-2 class of anti-inflammatory drugs. The agency began a re-examination of the COX-2 inhibitors after Merck voluntarily withdrew Vioxx from the market in September, and after the FDA asked Pfizer to halt all consumer marketing on Celebrex in December, in the wake of new clinical trials that showed an increased risk of heart attack. Celebrex remains on the market.

In addition to the Bextra news, the FDA also told Pfizer to begin including the dreaded "black box" warning on the Celebrex label. The black box is an additional warning placed on certain brands that carry what the FDA determines have higher risks or side effects.

Similar action in Europe
In a statement, Pfizer said it disagreed with the FDA's evaluation but agreed to suspend sales and marketing of Bextra in the U.S. pending further discussions with the FDA. Early this morning, Pfizer also agreed to a request from the European Union to stop selling Bextra in Europe.

Bextra is Pfizer's eighth-biggest-selling drug at $1.2 billion, according to NDC Health, though the company provided only minimal ad support. Measured media for Bextra in 2004, according to TNS Media Intelligence, was just $4.8 million.

Warning labels
The FDA is also asking manufacturers of similar nonsteroidal anti-inflammatory drugs (NSAID) to include the same boxed warning highlighting the potential for increased risk of cardiovascular events and gastrointestinal bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for cardiovascular and gastrointestinal bleeding associated with the use of this class of drugs.

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," Dr. Steven K. Galson, acting director of FDA's Center for Drug Evaluation and Research, said in a statement. "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks."

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