And Then There was One -- BEXTRA Pulled Out

The painkiller Bextra was taken off the market Thursday, and the
government wants similar prescription drugs to carry the strongest
possible warnings about increased risk of heart attack and stroke
among millions of people who rely on them.

Pfizer Inc. suspended sales of Bextra in the United States and the
European Union on Thursday at the request of the Food and Drug
Administration and European regulators. The company said the FDA, in
seeking Bextra's withdrawal, cited risk of serious, sometimes fatal,
skin reactions to Bextra on top of risks shared by other similar
drugs.

At issue are a broad class of painkillers known as nonsteroidal
anti-inflammatory drugs. Bextra is a particular type of
anti-inflammatory known as a Cox-2 inhibitor, a class of blockbuster
sellers particularly popular among arthritis sufferers until a
competitor — Vioxx from Merck & Co. — was pulled off the market last
fall. That sparked questions about the safety of all similar drugs.

Pfizer's Celebrex still can be sold, the FDA announced Thursday. But
it, and all other prescription nonsteroidal anti-inflammatories carry
a black-box warning on its label that users may face an increased risk
of cardiovascular side effects.

Scientists don't have enough information yet to tell if one of the
remaining prescription painkillers is safer than another, FDA
officials said. But the agency decided Bextra was more dangerous than
its competitors because of the added skin side effect.

In addition to the prescription drugs, the FDA asked manufacturers of
over-the-counter NSAID painkillers to revise their labels to clarify
information about the risks of cardiovascular incidents,
gastrointestinal bleeding and rare but serious skin reactions.

That doesn't mean nonprescription drugs are dangerous, FDA officials
said — but the strengthened wording will make clear patients should
take those drugs only at the labeled dosage for short periods of time.