Getting a headache trying to choose a painkiller (search)?
The government's advice to consumers is similar to what women were told after problems emerged with hormone pills for menopause (search): Take the lowest possible dose for the shortest possible time, and talk with your doctor about what is best for you.
Bextra's withdrawal and new warnings on similar drugs underscore that no medicine is without risk, but nonprescription pain pills appear safe when taken at the suggested dose and for no longer than two weeks, federal officials said.
"The over-the-counter products, when taken according to instructions ... are not an issue, and people should not worry about them," said Dr. Steven Galson, acting director of the Food and Drug Administration's Center for Drug Evaluation and Research.
Here are answers for consumers:
Q. Which drugs are off the market and why?
A. Vioxx and Bextra, called cox-2 inhibitors (search), have been removed by their makers. A third, Celebrex (search), is still being sold. Vioxx (search) and Bextra (search) raised the risk of heart disease and strokes, and Bextra also has been linked to serious skin problems.
Q. Are problems limited to these two drugs?
A. No. FDA officials think that all prescription drugs in a wider category called nonsteroidal anti-inflammatory drugs, or NSAIDS, might carry some risk of cardiovascular problems and should now carry warnings. They said Celebrex's benefits appear to outweigh its risks "in properly selected and informed patients," and that is why it is allowed to remain on the market. There are a variety of other prescription NSAIDS.
Q. How about over-the-counter ones?
A. Nonprescription NSAIDS (search) include aspirin, ibuprofen (Motrin, Advil, Medipren, etc.), naproxen (Aleve) and ketoprofen (Orudis, Actron). FDA says information so far does not suggest a risk of cardiovascular problems from short-term, low-dose use of these products. But makers of products containing ibuprofen, naproxen and ketoprofen are asked to revise labeling to include more information on potential cardiovascular and stomach bleeding risks, advice to consult doctors before using the drugs, reminders about limiting the dose and duration of use, and a warning about possible skin reactions.
Q. What about aspirin, and why aren't label changes sought for it?
A. Aspirin is an NSAID but it also is an anti-clotting agent that lowers the risk of cardiovascular problems. People taking aspirin for this purpose should not stop unless their doctor tells them to.
Q. Are there any pain relievers that aren't NSAIDS?
A. Yes — acetaminophen (search) (Tylenol).
Q. What if I have problems with a drug?
A. Doctors and patients can report problems to the MedWatch program via this their web site, by phone, 1-800-FDA-1088 or by fax, 1-800-FDA-0178.
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