FDA proposal stresses caution on painkillers
WASHINGTON -- A recent Food and Drug Administration proposal to add stronger warning labels to several popular types of over-the-counter painkillers, noting they pose a risk of liver and stomach damage, shouldn't scare most consumers into avoiding the products entirely, experts say. But the news should remind patients to take the lowest dose needed for the shortest possible time and to be aware of the ingredients contained in all of their medications, particularly when taking more than one medicine.
Under the FDA's proposal, warnings would be added to the labels of all over-the-counter medicines containing acetaminophen and nonsteroidal anti-inflammatory drugs , including aspirin, naproxen, and ibuprofen. Affected products include such popular brands as Tylenol, Aleve, Motrin, and Advil. The warnings would "include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor," the FDA reports in a written statement.
"In general, I think occasional use is safe," except in high-risk patients, said Jack Di Palma, immediate past president of the American College of Gastroenterology. High-risk patients include people older than 60, those taking the medications for longer than directed, patients taking blood thinners or more than one medication containing a nonsteroidal anti-inflammatory drug , and patients who have experienced ulcers or stomach bleeding.
Gastroenterologists have been discouraging the use of nonsteroidal anti-inflammatory drugs for patients in these groups for years, he said.
Doctors have known for years that nonsteroidal anti-inflammatory drugs can cause kidney damage and gastrointestinal bleeding in some patients, even when taken at recommended dosages. They've also known acetaminophen can cause severe liver damage when taken at higher than recommended doses or in combination with three or more alcoholic drinks per day. The FDA has defended the pace of agency action, citing regulatory procedures. But Public Citizen, a Washington-based consumer advocacy group, said the FDA's proposal comes "decades late"; the group wants the agency to require warnings in painkiller ads and make public service announcements about the change.
The FDA also is considering whether to impose limits on the number of acetaminophen tablets sold per bottle.
