Blow To Pfizer, Pain Sufferers

FDA drugs medicine prescription counterfeit Food and Drug Administration
The painkiller Bextra was taken off the market Thursday, and the government wants other drugs in the same class to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them.

Pfizer Inc. 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 that the FDA, in seeking Bextra's withdrawal, cited a risk of serious skin reactions to Bextra on top of the risks shared by other similar drugs.

The boxed warning recommended for the other non-steroidal anti-inflammatory prescription drugs is the strongest available to the FDA.

"This is not an emergency in the sense that these drugs could be immediately harmful to anyone," said CBS News Medical Correspondent Dr. Emily Senay.

"However," she added, "it's clear that the FDA feels strongly enough to act that Bextra be taken off the market."

In addition to the prescription drugs, the FDA asked manufacturers of related over-the-counter painkillers such as Advil and Motrin to revise their labels to include information about the risks of cardiovascular incidents and gastrointestinal bleeding.