Pfizer Takes Painkiller Bextra Off Market

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http://www.chicagotribune.com/business/sns-ap-fda-painkillers,1,2181379.story

 

Pfizer Takes Painkiller Bextra Off Market

 

By CONNIE CASS

Associated Press Writer

April 7, 2005, 9:40 AM CDT

 

WASHINGTON -- 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 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, sometimes fatal, skin reactions to Bextra on top of the risks

shared by other similar drugs.

 

At issue are a broad class of painkillers known as nonsteroidal

anti-inflammatory drugs, or NSAIDS. Bextra is a particular type of NSAID known

as a Cox-2 inhibitor, a class of blockbuster sellers particularly popular among

arthritis sufferers until a competitor -- Vioxx -- was pulled off the market

last fall. That sparked questions about the safety of all similar drugs.

 

Pfizer's Celebrex can still sell, the FDA announced Thursday. But it, and all

other prescription NSAIDS, must 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 stressed. But, the

agency decided that 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 the nonprescription drugs are dangerous, FDA officials

stressed -- but the strengthened wording will make clear that patients should

take those drugs only at the labeled dosage for short periods of time.

 

" People should not have a concern about continuing to take those products per

those directions, " said Dr. Steven Galson, acting director of FDA's Center for

Drug Evaluation and Research.

 

For users of prescription-strength NSAIDS, the government said there was no

reason to panic but that people should consult their physicians about which

painkiller is best suited for them -- and to take the lowest effective dose.

 

" All these risks we're talking about have already been known, " Galson stressed.

" People should not worry about, from today to tomorrow, stopping the products. "

 

Pfizer's advice to Bextra users: " For now, patients should stop taking Bextra

and contact their physicians about appropriate treatment options. "

 

Pfizer said it " respectfully disagrees " with FDA that Bextra was too risky to

continue selling, and pledged further discussions with the agency about the

possibility of returning it to the market.

 

Pfizer shares fell about 3 percent soon after Thursday's opening bell on the New

York Stock Exchange.

 

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 -- although it only narrowly backed Bextra. The panel said Vioxx posed the

greatest heart risk and that Celebrex seemed have the fewest cardiovascular side

effects among the Cox-2 drugs. It also recommended that the prescription drugs

carry strong warnings, and that more study be done to better understand the

drugs' risks.

 

On the Net: Food and Drug Administration:

http://www.fda.gov/cder/drug/infopage/cox2/default.htm

2005, The Associated Press

 

 

 

Laura

 

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