World’s biggest drugmaker, suspended sales of Bextra

Pfizer Inc. the world’s biggest drugmaker, suspended sales of Bextra in the United States and the European Union at the request of the Food and Drug Administration and European regulators. The company said the FDA, in seeking its withdrawal, cited a risk of serious skin reactions to Bextra. Pfizer will add a warning to its other painkiller, Celebrex, highlighting the potential of increased cardiovascular risks.

Pfizer has already pulled advertising for Celebrex over concerns that high doses of the medication may be linked to elevated risks of heart attacks.

Older painkillers such as aspirin will have to carry cautions about the possibility of cardiovascular and gastrointestinal risks, the agency said.

In addition to the prescription drugs, the FDA asked manufacturers of over-the-counter nonsteroidal anti-inflammatory drugs to revise their labels to include information about the risks of cardiovascular incident and gastrointestinal bleeding.

The risks posed by Bextra outweigh its benefits, the FDA said.

The FDA has been studying the safety of the so-called Cox-2 inhibiters since Merck & Co. voluntarily pulled Vioxx from the market Sept. 30 after heart problems were reported in some users. Once blockbuster sellers, the painkillers were particularly popular among arthritis sufferers.

The panel said Vioxx posed the greatest risk and that Celebrex had the fewest side effects. It recommended that the prescription drugs carry strong warnings and that more study be done to get a better understanding about the drugs.

The FDA said Thursday it will “carefully review any proposal from Merck for resumption of marketing of Vioxx.” In February, two FDA advisory committees meeting jointly voted by a narrow margin to recommend that Vioxx be allowed to return to the market subject to certain restrictions. Merck offered no immediate comment to the FDA’s announcement.

“For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options,” Pfizer said in a statement Thursday.

In February, advisers to the FDA had recommended that people who depend on Celebrex, Bextra and Vioxx be allowed to continue to use them despite the health risks.

Shares of New York-based Pfizer fell 86 cents, or 3.2 percent, to $26 as of 9:30 a.m. in New York Stock Exchange composite trading.

Merck shares fell 58 cents, or 1.8 percent, to $32.31, in early trading also on the NYSE.

Pfizer said it planned further discussions with the FDA about the possibility of returning Bextra to the market.
“Pfizer respectfully disagrees with FDA’s position regarding the overall risk-benefit profile of Bextra,” the company said.

The FDA went against the advice of a panel of doctors and scientists, which in February concluded that Bextra was beneficial enough to justify its continued sale.

“They stood up and defended the product saying there were no side effects, now the FDA has withdrawn it and there is a likely threat of litigation,'’ said Karl Heinz Koch, a drug analyst at Lombard Odier Darier Hentsch in Zurich. “There will certainly be an investigation as to whether or not there was any wrongdoing by Pfizer.'’