Like millions of Americans who use prescription painkillers, Melissa Hafeli, 32, is confused. Diagnosed with juvenile rheumatoid arthritis when she was a child, she has depended on the drug Celebrex for years to help her perform daily tasks without debilitating pain. Until now. On April 7 the FDA recommended "black box" labels for the drug, warning of increased risk of heart disease and stomach problems. In a more surprising development, the agency also called for warning labels on bottles of Advil, Aleve and Motrin—three of the most common over-the-counter pain medications in use today for headaches, sore muscles and menstrual cramps. "There aren't really any viable options for me," says Hafeli. To help understand the new developments, here are six questions and answers.
Why is the FDA calling for warning labels on Advil, Aleve and Motrin?
Because they are related to other drugs that have been linked to heart disease and stroke. Pending further investigation, the FDA wants warning labels on all drugs in this large family of painkillers known as nonsteroidal anti-inflammatory drugs or NSAIDs.
Does that mean I should stop taking Advil?
No. Drugs containing ibuprofen (the active ingredient in Advil and Motrin) and naproxen (found in Aleve) will remain on sale. But ask your doctor if you have risk factors or other reasons to be cautious.
What other painkillers can I use?
Aspirin and Tylenol (acetaminophen). Both are generally considered safe for people with temporary pain like headaches and the aches and pains of "weekend warrior" sports buffs—although aspirin can cause stomach irritation and bleeding, and Tylenol should not be taken by anyone who drinks three or more alcoholic beverages a day without consulting a doctor.
Why were Vioxx and Bextra taken off the market?
The primary reason is evidence from recent studies that these prescription medications, called Cox-2 inhibitors (which block a hormone that promotes inflammation), may double the risk of heart attacks and strokes. Bextra has also been linked to serious skin conditions—the FDA has identified three so far—that are rare but can be fatal. Celebrex remains on the market but will soon carry a strong warning, to be printed in a black box on the label, that tells of possible cardiovascular and gastrointestinal problems.
What should I do if I am currently on one of these drugs?
If you are still taking Bextra, stop immediately. If you take Celebrex, contact your doctor about the potential risks.
How about drug therapies for really serious pain?
Many doctors may recommend combinations of older generation NSAIDs that predate the introduction of Cox-2 inhibitors or try to manage pain with aspirin, Tylenol, naproxen and ibuprofen. But for some people, doing without their pain medication means the difference between leading a normal life or remaining inactive. Given the new warnings, they must now decide whether the benefits outweigh the risks.
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