FDA: Pain relievers should carry alcohol warning
November 14, 1997
Web posted at: 9:38 p.m. EST (0238 GMT)
WASHINGTON (CNN) -- The U.S. Food and Drug Administration says mixing over-the-counter pain relievers and excessive alcohol is dangerous, and the medicines should carry a warning label.
The labels would be required on aspirin and pain medicines containing the drugs acetaminophen, ibuprofen, naproxen sodium and ketoprofen. It would include common pain relievers such as Tylenol, Aleve, Orudis KT and Actron.
The proposed label would suggest that users consult a physician before taking the product if they consume three or more alcoholic beverages daily.
"Consumption of excessive alcohol while taking pain relievers can be dangerous to your health," said the FDA's acting commissioner, Dr. Michael Friedman, citing risks of liver damage and stomach bleeding.
The proposal follows an extensive FDA review of data on the effect of alcoholic beverages on users of various over-the-counter pain relievers.
Several recent studies have shown liver damage in some patients who consumed large amounts of alcohol while using acetaminophen, the active ingredient in Tylenol. There has also been evidence that heavy alcohol consumption while using aspirin, ibuprofen or naproxen sodium increases the risk of gastrointestinal bleeding.
McNeil Pharmaceuticals, which makes Tylenol, already places an alcohol warning on its packaging, though it is not as explicit as what the FDA proposes.
Friday's action opens a 90-day comment period, in which the public can respond to the proposed rule. A final rule would then be developed and published in the Federal Register.
The Aspirin Foundation of America, an industry group, announced that it would fight the FDA proposal.
Despite the studies, there are still questions as to just how much alcohol might put users of these pain relievers at risk.
Dr. David Flockhart of Georgetown University said few people are hurt by mixing alcohol and pain relievers each year. But those who are injured are usually hurt severely -- and there's no way to predict in advance who can tolerate the mix.
However, Flockhart said heart patients on aspirin therapy aren't at any higher risk from alcohol than the average aspirin user because their daily dose is low.
For people whose drinking habits fluctuate, the FDA is also tracking some reports of occasional drinkers who suffered pain-pill side effects.
"The warnings say three drinks or more daily, but that doesn't mean if you're having three drinks every other day you shouldn't consult your doctor," said Dr. Linda Katz, the FDA's non-prescription drugs chief.