Pfizer Halts Arthritis Drug After Warning on Risks

Pfizer agreed Thursday to suspend sales of its painkiller Bextra at the request of the U.S. Food and Drug Administration, which also said it was instructing drug makers to better warn patients of the health risks of other widely used painkillers in the same class. Bextra belongs to a class of drugs that has been linked to higher risk of cardiovascular disease, but the reason given by both the government and Pfizer for the withdrawal of Bextra was an additional risk of a potentially serious skin reaction. Pfizer said it disagreed with the U.S. regulator’s position on the overall risks from Bextra, used to treat arthritis and similar ailments. But it said it would suspend marketing of Bextra pending discussions with the agency and added that patients should stop taking the drug. It also said that it would suspend sales of Bextra in the European Union as requested Thursday by regulators there. The European Medicines Agency described the suspension as an “interim measure” awaiting the completion of a review of COX-2 inhibitors, which it began after Merck’s withdrawal of Vioxx. It said it would release an update of its plans after an April 18-21 meeting of the agency’s Committee for Medicinal Products for Human Use.

In a news release and public health advisory on its Web site, the FDA announced new rules aimed at the marketing of not only COX-2 inhibitors like Bextra and Celebrex, another Pfizer drug, but also older over-the-counter pain relievers like ibuprofen and naproxen. A boxed warning on a drug’s label and an enclosed medication guide should highlight the potentially greater risk of “cardiovascular events,” like heart attacks and strokes, and gastrointestinal bleeding associated with taking the drug. The FDA said the actions “are based on the available scientific data, including data accumulated since the drugs were approved.” Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement, “Today’s actions protect and advance the health of the millions of Americans who rely on these drugs everyday.” The agency’s re-examination of the health risks of such drugs began after Merck voluntarily withdrew Vioxx worldwide in September. Since then, the popular COX-2 drugs, which have treated millions of people with arthritis and other chronic ailments, have been in danger of removal from the market, calling into question the financial health of their makers and the rigor of the FDA.

The FDA said Thursday that it would “carefully review any proposal from Merck for resumption of marketing of Vioxx.” In explaining its decision on Bextra, the FDA said, “the overall risk versus benefit profile for the drug is unfavorable.” Pfizer said in a statement that it “respectfully disagrees with FDA’s position regarding the overall risk/benefit profile of Bextra. However, in deference to the agency’s views, the company has agreed to suspend sales of the medicine pending further discussions with the FDA.” For Pfizer, the world’s largest drug maker, complying with the FDA’s request may compromise the profit growth that the company forecast on Tuesday in a meeting with Wall Street analysts. Although it said that 2005 would be a “transition year” of cost cutting and research spending, it had predicted double-digit earnings growth starting in 2006. Moreover, an advisory panel of doctors convened by the FDA earlier this year narrowly voted to keep Bextra on the market.

“It’s a setback; we had been assuming that Bextra would probably be staying on the market,” said Carl Seiden, an equity analyst at UBS who still rates the stock a buy. “We’re going to assume that Bextra revenues are simply lost and not made up by Celebrex.” That would mean a $560 million loss in worldwide revenue, or about 2.5 percent of the company’s projected earnings, according to Seiden’s calculations. Shares of Pfizer on the New York Stock Exchange closed down 36 cents at $26.50.