New warnings that mixing alcohol with over-the-counter pain relievers can lead to stomach bleeding or liver damage will be included this month in packages of the drugs Tylenol and Motrin IB, the manufacturer said yesterday. Brian Perkins, president of McNeil Consumer Products Co. in Fort Washington, Pa., said new packaging that includes the warnings should begin appearing on store shelves by the end of July. The action comes in response to a November proposal by the federal Food and Drug Administration. The warnings will say that persons who consume three or more alcholic drinks per day should beware of taking Motrin IB for risk of stomach bleeding and should avoid over-large amounts of Tylenol because of potential liver damage. Richard Dart, director of the Rocky Mountain Poison and Drug Center in Denver, said such warnings are generally targeted to heavy drinkers.

An FDA representative said yesterday that the federal agency did not order the label change but has been studying the issue to address safety concerns. In a November hearing on the issue, the FDA cited 139 references to alcohol-and-analgesic studies in proposing that McNeil make its warnings stronger. Even without alcohol, acetaminophen use has long been linked to stomach bleeding, especially when taken alone, on an empty stomach. Doctors have also known there was a risk from alcohol and some pain pills. A Virginia man who blamed his liver transplant on taking Tylenol while drinking three or four glasses of wine with dinner won an $8-million jury award in 1994. McNeil Pharmaceuticals insisted Tylenol wasn't to blame, but the following year it put alcohol warnings on all Tylenol products that tell drinkers to see a doctor if they take not just Tylenol but a list of other pain relievers, including aspirin and ibuprofen. Aspirin makers, however, disputed the FDA's conclusions. "Bayer is not aware of . . . any clinical studies demonstrating a linkage of aspirin and alcohol use to an increased risk of gastric bleeding," said spokeswoman Chris Ervin.

Copyright 1998, Newsday Inc.