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FDA: Don't overdo pain pills

Posted - Dec. 27, 2004 at 6:40 a.m.



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Just because you can buy a pain reliever along with your morning coffee and doughnut at the local convenience store doesn't necessarily mean it's safe to pop the pills for weeks on end.

That's the message the Food and Drug Administration is trying to get out to consumers. If you think you need to take naproxen, ibuprofen or aspirin -- all nonsteroidal anti-inflammatory drugs, or NSAIDs -- for longer than 10 days, do so under a doctor's supervision, the agency is now advising. And don't take any more pills a day than the label, or your doctor, recommends.

If your doctor has prescribed Celebrex or Bextra, two newer NSAIDs known as COX-2 inhibitors, you and your doctor should discuss whether you really need to take the drugs, according to a just-released health advisory from the FDA.

If you're at risk for a heart attack or stroke but not for digestive tract bleeding, you probably should stick with an older NSAID. Theoretically, the COX-2 inhibitors are less likely to cause digestive tract bleeding, but Pfizer, maker of Celebrex and Bextra, has not yet been able to convince the FDA that it should be able to make that claim on the drugs' labels.

''We have held the COX-2s to a very high standard to get an indication (label claim) for reduced gastrointestinal bleeding,'' says John Jenkins, director of the FDA's Office of New Drugs.

At a news conference Friday, Jenkins called the public health advisory ''an interim measure, pending further review of data that continue to be collected.''

In recent weeks, studies comparing Celebrex, Bextra, Vioxx and naproxen -- an older NSAID sold over-the-counter as Aleve -- with a placebo have shown that they could increase the risk of heart attack and stroke, especially if taken for long periods or by people who are at high risk for such problems. Merck pulled its COX-2 inhibitor, Vioxx, off the market Sept. 30, but Celebrex and Bextra remain.

Though aspirin has been shown to reduce the risk of heart attack or stroke in people who already have had one, it also is among the NSAIDs most likely to cause a stomach ulcer, Jenkins said.

In light of the new information about risks of heart attack and stroke, Jenkins said, the FDA is requiring that researchers re-evaluate all prevention studies -- in which healthy people are given a drug to see whether it prevents a disease or condition -- involving Celebrex or Bextra.

That's not good enough, says consumer advocate Sidney Wolfe, director of Public Citizen's Health Research Group. Wolfe has called for the FDA to ban Celebrex and Bextra.

''The FDA is once again siding with a large pharmaceutical company,'' he says.

Pfizer, maker of Celebrex and Bextra, says a planned FDA advisory committee meeting on COX-2 inhibitors in February ''is the appropriate forum for a thorough review of all available data.''

Meanwhile, the company said Friday in a statement that ''patients should continue to consult their doctor to ensure they get the pain treatment appropriate for their individual medical need.''

To see more of USAToday.com, or to subscribe, go to http://www.usatoday.com

© Copyright 2004 USA TODAY, a division of Gannett Co. Inc.

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