Summary
The FDA has issued a statement that people should not take over-the-counter painkillers for longer than ten days. With new studies showing that the painkillers Vioxx, Aleve, and Celebrex increase the risk of heart attack and stroke, the FDA is treading carefully, pending further studies. However, many consumer advocates are not pleased with this warning and are urging the FDA to enact a ban on Vioxx, Celebrex, Bextra, and naproxen.
Original source:
http://www.usatoday.com/news/health/2004-12-26-painkillers_x.htm
Details
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.
Time release: Pain relievers shouldn't be taken longer than 10 days, according to the FDA.
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.
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.
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.
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