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FDA: Bextra side effects are `potentially' life-threatening

Feb 9, 2006 | Bloomberg News

Pfizer Inc.'s pain pill Bextra should be kept off the market permanently because of potentially life-threatening side effects, federal regulators said Wednesday.

Food and Drug Administration staff members concluded that the drug has greater health risks than similar painkillers, including Pfizer's Celebrex and Merck & Co.'s withdrawn Vioxx, according to documents posted on the agency's Web site.

Pfizer voluntarily suspended sales of Bextra last April 7 at the request of regulators.

The drug, which generated $1.29 billion in 2004 revenue, was linked to a rare, fatal skin disorder and an elevated risk of heart attacks.

Pfizer officials in May said they hoped to resume selling the drug, also known as valdecoxib.

"In the absence of any demonstrated advantage over other [pain medications], the overall benefit versus risk profile for valdecoxib is unfavorable for marketing," the FDA staff members wrote in documents prepared for an advisory committee hearing this week.

"The agency should ask Pfizer to voluntarily withdraw Bextra from the U.S. market. In the event Pfizer does not agree to a voluntary withdrawal, the agency should initiate the formal withdrawal procedures."

A Pfizer spokeswoman said, "Pfizer continues to speak to the FDA about the Bextra application and look for ways to make Bextra available to patients who can potentially derive benefit from the medication."

Bextra will be part of a review of the FDA's monitoring of risks associated with pain medications at a meeting of government advisers Friday in Gaithersburg, Md.

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