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Bextra Pain Drug Pulled Off Market ; FDA Cites Health Risk, Orders Warning Labels on Other Medications

Posted on: Saturday, 9 April 2005, 03:00 CDT

The painkiller Bextra was yanked off the market yesterday, and the government ordered that 19 other popular prescription competitors carry tough new warnings on health risks.

The Food and Drug Administration said the possibility that Bextra may increase the risk of heart attacks and strokes makes the drug too risky to remain on the market. Bextra is used to treat arthritis and similar ailments.

The FDA went against advice from a panel of doctors and scientists at a February hearing that Bextra's benefits outweighed its risks and should remain on the market. Pfizer suspended Bextra sales in the United States and European Union yesterday while saying it "respectfully disagrees" with the FDA's ruling.

The moves come six months after Merck & Co. withdrew its related pain drug Vioxx because a company study linked it to an elevated risk of heart attacks and strokes.

Now the FDA has ordered that an entire class of anti- inflammatory medicines -- from Celebrex to Mobic to high-dose naproxen -- carry black box warnings, the strongest the FDA can order, that they may increase the risk of heart attacks and strokes and should be taken only in low doses for a short time.

The drugs, called NSAIDs, are the backbone of U.S. pain treatment.

Aspirin won't have such a warning because it has been shown to protect against heart attacks, the agency said.

All prescription NSAIDs must carry a major warning that long- term use may cause serious cardiovascular side effects or gastrointestinal bleeding.

Also, patients are to receive a pamphlet with every NSAID prescription that spells out the warnings in consumer-friendly language.

Worried patients immediately began calling doctors and pain groups to ask what drug they should take. The FDA advised patients to ask which painkiller is best suited to their personal health risks, and then take the lowest dose possible.

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

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

Pfizer pledged additional research on Bextra's heart risks and said it would try to bring back the drug.

The FDA's re-examination of the health risks of such drugs began after Merck voluntarily withdrew Vioxx worldwide in September 2004 after a study showed long-term use doubled patients' risk of heart attacks and strokes.

Pfizer'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, though apparently to a smaller degree than Vioxx.

Pfizer's Celebrex still can sell, the FDA announced yesterday. Celebrex, with sales of $3.3 billion last year, is the nation's last cox-2 inhibitor remaining on sale.

Use of cox-2 inhibitors skyrocketed, particularly among people with arthritis and other chronic pain, when they hit the market in the late 1990s because of claims that they were easier on patients' stomachs than traditional painkillers. The FDA cautioned that those claims were never proven.

Bextra generated $1.29 billion, or 2.4 percent, of New York- based Pfizer's revenue last year. Pfizer shares initially fell almost 5 percent in trading yesterday on the New York Stock Exchange but ended the day little changed at $26.90. Before yesterday, they had fallen 25 percent in the past year.

Impact

More than 7 million have used Bextra worldwide since 2002.

On the Internet

A list of cox-2 inhibitors and NSAID drugs is available on the FDA's Web site at :

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

Source: Richmond Times - Dispatch

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