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Posted 4/7/2005 9:27 AM     Updated 4/7/2005 11:21 AM

At FDA request, Pfizer pulls painkiller Bextra off market

From staff and wire reports

WASHINGTON — Pfizer (PFE) agreed Thursday to suspend sales and marketing of the arthritis drug Bextra at the request of U.S. drug regulators, who say the risks outweigh the benefits.

Regulators also want all other anti-inflammatory 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 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.

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.

The Food and Drug Administration has been studying the safety of the COX-2 inhibitors since Merck (MRK) voluntarily pulled Vioxx from the market Sept. 30 after heart problems were reported in some users.

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs every day," said Dr. Steven Galson, acting director of FDA's Center for Drug Evaluation and Research.

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.

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

While suspending sales, Pfizer says it disagrees with the agency view on Bextra.

Pfizer says it plans further discussions with the FDA about the possibility of returning Bextra to the market.

But for now, Pfizer says patients should stop taking Bextra and contact their physicians about appropriate treatment options.

In a statement, Merck said Thursday that while it respects the FDA's decision on selective COX-2 inhibitors, "It is important to recognize that the millions of patients who continue to suffer with pain need effective therapies and selective COX-2 inhibitors have provided important therapeutic benefits to patients. We look forward to discussions with the FDA."

Pfizer announced earlier this week that its earnings would fall this year.

Part of the problem is that new prescriptions for painkillers Celebrex and Bextra, with $4.6 billion in 2004 sales, have fallen sharply because of heart attack and stroke concerns.

Pfizer will lose the vast majority of its Bextra sales for the year, analysts say, adding that Celebrex sales will take a huge hit as doctors and patients question the safety of the only remaining COX-2 inhibitor on the market.

"If you are a doctor looking at this, how can you think there are problems with two and not the third," says Jason Napodano, an analyst with Zacks Investment Research.

Napodano expected Celebrex sales of $2 billion but they could be slashed to only $1 billion. He expected Bextra revenue of $605 million but most of that has just evaporated.

He says he believes the FDA decision will shave at least 5 cents from Pfizer earnings this year.

Contributing: Julie Schmidt, USA TODAY

Copyright 2005 The Associated Press.

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Homemade Fish Sticks

They’re easy; they’re fun and much better for you those high-fat frozen fish sticks!

Ingredients:

1 lb of haddock or cod, cut into sticks
1 beaten egg white
1 ½ tablespoon of canola oil
¾ cup of cornflake crumbs
½ teaspoon of onion powder or onion flakes
3 tablespoons of Parmesan cheese
Dash of salt and pepper

Directions:

1. Preheat oven to 400F.
2. Mix together beaten egg white and oil.
3. Combine cereal crumbs, onion powder (or flakes), Parmesan, salt and pepper.
4. Dip fish sticks into egg white mixture, and then roll in the seasoned flakes.
5. Bake 10 to 15 minutes, turning once.

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