- The Washington Times - Thursday, April 7, 2005

The Food and Drug Administration yesterday said Pfizer Inc. will pull its painkiller Bextra off the market as the pharmaceutical regulator announced stronger warning labels on other anti-inflammatory drugs, from Celebrex to Advil.

The FDA asked the New York pharmaceutical company late Wednesday to stop selling Bextra because it posed too many risks to benefit the public.

Nearly 12.9 million U.S. prescriptions last year were filled for Bextra, which posted $1.24 billion in 2004 U.S. sales, according to Fairfield, Conn., pharmacy information company IMS Health Inc.

The FDA also asked Pfizer to put a “black box” warning on its leading painkiller, Celebrex, which accounted for 23.8 million prescriptions and $3.3 billion in sales last year.

In addition to the increased risks associated with the anti-inflammatory drug class, reports also linked Bextra to risks for serious skin reactions, the FDA said.

The Bextra pullout comes 27 weeks after Merck & Co. Inc., a Whitehouse Station, N.J., pharmaceutical company, on Sept. 30 recalled its arthritis painkiller Vioxx from store shelves after a study connected the drug to higher risks for heart problems.

The measures are part of labeling changes the FDA requested for other anti-inflammatory medications in the same drug class, which include Bextra, Celebrex and widely used over-the-counter drugs like ibuprofen and naproxen.

The FDA requested that manufacturers of prescription versions in the drug class revise their labels to include boxed warnings that highlight the potential for increased risk of cardiovascular problems and gastrointestinal bleeding.

Additionally, the agency asked companies selling over-the-counter medications in the drug class to revise their labels to include more specific information on potential heart and stomach problems and assistance on how best to use the medicines.

An FDA advisory panel in February examined the safety of the “Cox-2” painkillers that are part of the drug class. Cox-2 painkillers work by targeting and suppressing the body’s production of a Cox-2 enzyme, which is linked with pain and swelling.

Pfizer yesterday said it “respectfully disagrees” with the agency’s evaluations of the drug. The company said it will explore options to bring Bextra back on the market.

Pharmaceutical analyst Jami Rubin, with New York investment bank Morgan Stanley, said the Bextra withdrawal was a “minor setback.”

“The company had clearly already been positioning Celebrex as the lead horse in its Cox-2 franchise,” Ms. Rubin said, rating the stock as “overweight,” or a buy.

Shares of Pfizer, which agreed to stop Bextra sales in the United States and Europe pending further talks with the FDA and European regulators, initially fell on the New York Stock Exchange but closed 4 cents higher at $26.90 yesterday. The stock price closed at $26.86 Wednesday.

Ms. Rubin, who owns an undisclosed amount of Pfizer stock, said she doubted the FDA announcement would lead to a rush of lawsuits against Pfizer.

Hundreds of class-action personal-injury lawsuits have been filed against Merck since Vioxx was pulled from the market.

Dr. Steven Galson, acting director for FDA’s Center for Drug Evaluation and Research, said the agency closely followed recommendations from the advisory panel.

That panel ruled Vioxx, Celebrex and Bextra could continue to be sold but only with strict warnings. The panel also said older pain relievers like ibuprofen and naproxen should have warning labels, even if they only state a lack of clear information about potential heart risks.

Dr. Galson said yesterday the FDA is working on drafting the language for the warnings and medication guide it is asking drug manufacturers to use.

While the new boxed warnings may not appear on drug packages for some time, “we do expect companies to voluntarily run promotions starting [yesterday] that acknowledge these risks,” Dr. Galson said.

Along with its call for boxed warnings, the FDA said it will review any proposal from Merck to resume selling Vioxx, which accounted for $2.5 billion in 2003 sales and more than 91 million U.S. prescriptions since its introduction in 1999.

Merck’s stock on the New York Stock Exchange rose to $33.49 yesterday, up 60 cents from Wednesday’s price of $32.89.

Merck spokeswoman Jeanine Clemente said the company would not say anything beyond its previous statement that Merck had not ruled out bringing Vioxx back into the market, depending on decisions by the advisory panel and FDA on the drug class.

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