- The Washington Times - Wednesday, February 8, 2006


Pfizer Inc.’s pain pill Bextra should be kept off the market permanently because of potentially life-threatening side effects, U.S. regulators said yesterday.

The side effects include heart attacks and a rare, fatal skin disorder, the U.S. Food and Drug Administration said in a memorandum posted yesterday on its Web site. The 19-page document, prepared last April, concluded that Bextra should be withdrawn. Six months earlier, Merck & Co. pulled its similar Vioxx pain drug from the market because of heart risks.

Pfizer said yesterday that it plans to continue its bid to resume U.S. sales of Bextra, which were suspended in April at the FDA’s request.

“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,” said Shreya Prudlo, a spokeswoman for New York-based Pfizer.

Bextra will be part of a review of the FDA’s monitoring of risks associated with pain medications at a meeting of government advisers tomorrow in Gaithersburg. The committee was part of a panel that held three days of hearings a year ago after the Vioxx withdrawal and subsequent findings that Bextra and Pfizer’s related Celebrex also may elevate the risk of heart attacks and strokes.

Last year’s hearing was part of the FDA’s response to criticism by lawmakers that the agency failed to monitor the safety of Vioxx and the other pain drugs. After generating $2.5 billion in 2003 sales, Merck’s Vioxx has since become the focus of at least 9,650 lawsuits in the U.S.

Pfizer voluntarily suspended sales of Bextra last April after the FDA urged withdrawal of the product. Bextra sales reached $1.29 billion in 2004. Sales of Celebrex, still available by prescription with a warning on the package insert, fell 48 percent last year to $2.73 billion.

Shares of Pfizer, the world’s No. 1 drug maker, jumped $1.43, or nearly 5 percent, to close at $26.37 yesterday on the New York Stock Exchange. Pfizer said Tuesday that it might sell its consumer health unit, which last year generated $3.88 billion in sales of products including Listerine mouthwash, Sudafed cold medicine, Visine eye drops and the Rogaine hair-loss treatment.

The operation could fetch $8 billion to $10 billion, according to JP Morgan. The sale would help Pfizer make acquisitions and fund research to find products to replace drugs that are losing patent protection, analysts said.

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