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Painkiller Bextra off market

Pfizer took it off the shelf after the FDA cited cardiac concerns and risky skin conditions. All similar drugs were ordered to carry new warnings.

By Associated Press
Published April 8, 2005

Related: a look at Painkillers in the spotlight

WASHINGTON - The blockbuster painkiller Bextra was yanked off the market Thursday, and the government ordered that 19 other popular prescription competitors - from Celebrex to Mobic to high-dose naproxen - carry tough new warnings that they, too, may increase the risk of heart attacks and strokes.

The warnings encompass an entire class of anti-inflammatory medicines called NSAIDs that are the backbone of U.S. pain treatment, not just newer versions of the painkillers initially suspected when the heart concerns made headlines last fall.

The warnings - in black boxes, the strongest the Food and Drug Administration can order - are likely to cause confusion because they won't tell patients and doctors which of these prescription drugs is a safer choice.

In addition, the FDA will make over-the-counter NSAIDs, or nonsteroidal anti-inflammatory drugs, such as ibuprofen, naproxen and ketoprofen, bear stronger reminders to take only low doses for a few days at a time to avoid the same risks of high-dose, long-term use.

Worried patients began calling doctors and pain groups to ask what drug they should take.

There simply isn't enough research yet to rank which drug will pose fewer heart problems, said FDA drug chief Steven Galson. "A lot of the data conflicts," he said.

The FDA is asking painkiller manufacturers to sift through their research to help figure that out.

"Let me emphasize now, this announcement is unlikely to be the last word you'll hear on these drugs," Galson said.

The saga began last September when Merck & Co. voluntarily pulled its pain reliever Vioxx off the market after a study showed long-term use doubled patients' risk of heart attacks and strokes. Pfizer Inc.'s Bextra and Celebrex are similar drugs, a subset of NSAIDs known as COX-2 inhibitors, and studies show they also can raise cardiovascular risks, although apparently to a smaller degree than Vioxx.

Some pharmacists in the Tampa Bay area had yet to hear of Bextra's removal from the market. Several said they would expect users to be disappointed.

"They won't like it," said Dennis Lake, a pharmacist with CVS in Seminole. "It really works."

Lake found that his customers were often impressed with Bextra's pain relief.

"It worked well for inflammation," he said. "It could be like Vioxx, where they pull it off the market, do some more testing and then consider putting it back on the market if they discover the risks are very, very minute."

Pete Ganio, a pharmacist with Walgreens in Madeira Beach, said a few customers had asked Thursday why they couldn't get Bextra anymore. Ganio suspected that many users of COX-2 inhibitors already knew many of the risks.

After Vioxx was pulled, many doctors of patients taking COX-2 inhibitors reviewed their medical histories and explained the drawback of taking the drugs.

Ganio thought patients continued taking Bextra because of how well it worked.

"They want relief from their pain and are willing to take some small risks to do it," Ganio said.

Pfizer suspended Bextra sales in the United States and the European Union on Thursday, at the request of the FDA and its European counterparts. The FDA said that in addition to the cardiac concern, Bextra appears to cause rare but serious skin conditions - some fatal - more often than do other NSAIDs, making the drug too risky to remain on the market.

Pfizer's Celebrex still can sell, the FDA announced Thursday.

But it and all other prescription NSAIDs must carry a major warning on the label that long-term use may cause serious cardiovascular side effects or gastrointestinal bleeding. No one who recently underwent heart bypass surgery should use prescription-strength NSAIDs, the warning stresses.

Also, patients are to receive a special pamphlet with every NSAID prescription filled that spells out the warnings.

Thursday's move was a blow to Pfizer, which said it "respectfully disagrees" with the FDA that the drug, which had sales of $1.3-billion last year, is too risky. Pfizer pledged additional research on Bextra's heart risks and said it would try to bring back the drug.

Celebrex, with sales of $3.3-billion last year, remains the nation's last COX-2 inhibitor on sale.

Times staff writer Graham Brink contributed to this report.

If I'm taking Bextra, what should I do?

Pfizer's advice to Bextra users: Stop taking the drug, and talk to your doctor. The FDA advises to ask which painkiller is best suited to your personal health risks, and then take the lowest dose possible.

What are the risks associated with these drugs?

NSAIDs, nonsteroidal anti-inflammatory drugs, have the potential for increased risk of cardiovascular problems and serious, potentially life-threatening gastrointestinal bleeding. In addition, Bextra was associated with the risk of skin reactions, including two types that can be deadly.

What about over-the-counter drugs?

The FDA said available information does not suggest an increased risk of serious cardiovascular problems for the short-term, low-dose use of the NSAIDs available over the counter, such as Aleve, Advil, Motrin and Actron. The agency asked manufacturers of these medicines to revise labeling to include more specific information about potential gastrointestinal bleeding and cardiovascular risks.

If I take these what should I do?

Carefully follow the label directions, particularly with regard to dose and duration of use. Call your doctor with questions.

Who may be at higher risk when taking any of these

Those at higher risk would include patients who have just had heart bypass surgery, people who have coronary artery disease, people who have had a stroke or who currently have episodes of transient ischemic attacks and people with a history of stomach ulcers.

Are there any pain relievers that aren't NSAIDS?

Yes - acetaminophen, such as Tylenol.

Where can I get more information?

To find out more about all NSAIDs from the FDA, click on or call toll-free, 1-888-463-6332.

Source: FDA, Associated Press


Pfizer Inc.'s earnings are likely to slump further this year and its recently released plan to return to double-digit earnings growth in 2006 and 2007 could be in jeopardy because of Thursday's decision to ban the sale of Bextra. But the damage may not be as bad as expected. Pfizer shares initially fell almost 5 percent Thursday, but ended the day little changed at $26.90. "We're going to assume that Bextra revenues are simply lost and not made up by Celebrex," Carl Seiden, an equity analyst at UBS who rates the stock a buy. That would mean a $560-million loss in worldwide revenues, or about 21/2 percent of the company's projected earnings, according to Seiden's calculations.


[Last modified April 8, 2005, 00:34:10]

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