Pfizer Inc. on Thursday agreed to halt sales and marketing of its arthritis painkiller Bextra at the request of US Food and Drug Administration (FDA).

Media reports said the company also took a similar move in Europe at the European regulators. Canadian health authorities also required the Pfizer to withdraw the drug.

The FDA also requested the Pfizer to use the black box -- the strongest it can order -- warning label for its painkiller Celebrex, which has been in studies linked with increased risk of heart attack and stroke.

In addition, the agency ordered dozens of other prescription or nonprescription NSAIDs, or nonsteroidal anti-inflammatory drugs, including ibuprofen and naproxen, which all are pain relievers, to carry new tougher warnings about risks of heart problems and gastrointestinal bleeding.

Aspirin is exempted from the FDA order for new warnings.

In explaining its decision on Bextra, the FDA said that besides cardiac concern, Bextra appears to cause more cases of rare but serious and sometimes fatal skin conditions.

"The overall risk-versus-benefit profile for the drug is unfavorable," it said in a statement.

Last December, the FDA recommended limited prescription of Celebrex and Bextra, which, like Merck & Co's Vioxx, are a part ofa subset of NSAIDs known as COX-2 inhibitors. COX-2 inhibitors are designed to reduce the risk of gastrointestinal bleeding associated with older painkillers like aspirin.

Merck voluntarily pulled its Vioxx out of the market last September after a study linked it with increased risk of heart attack and stroke. Although an advisory panel to the FDA in February approved the safety of Vioxx and its return to market, the FDA said Thursday in a statement that it would "carefully review any proposal from Merck for resumption of marketing of Vioxx."

The Pfizer said it "respectfully disagrees with FDA's position regarding the overall risk/benefit profile of Bextra." The drug maker said it would "explore options with the agency under which the company might be permitted to resume making Bextra available to physicians and patients."

The sales of Pfizer's Bextra and Celebrex totaled 1.3 billion and 3.3 billion US dollars respectively in 2004.

Source: Xinhua