To: Anthony Wong who wrote (488 ) 7/8/1998 8:09:00 PM From: Anthony Wong Respond to of 1722
J&J Adds Alcohol Warning to Motrin Label, Changes Tylenol Label Bloomberg News July 8, 1998, 6:25 a.m. PT J&J Adds Alcohol Warning to Motrin Label, Changes Tylenol Label New Brunswick, New Jersey, July 8 (Bloomberg) -- Johnson & Johnson said it will add a warning about alcohol use to the label for its painkiller Motrin and modify the painkiller Tylenol's label, which already warns about complications with alcohol use. The changes in the labels meet recent proposals from the U.S. Food and Drug Administration, said Johnson & Johnson, the world's fifth-biggest drugmaker, according to IMS Health Inc. The Motrin label will advise people who drink three or more alcoholic beverages a day to check with doctors about taking Motrin or other pain relievers. The drugs may increase risk of stomach bleeding. The Tylenol label, which already warns about alcohol use, will add that chronic heavy alcohol users may risk liver damage by exceeding the recommended dose of Tylenol. ''Generally, the alcohol warning on these products is targeted to the heavy user of alcohol,'' said Richard Dart, director at Denver's Rocky Mountain Poison and Drug Center. ''Occasional moderate drinkers who follow directions for appropriate dosing can be reassured that they can continue to use acetaminophen products, such as Tylenol, with confidence.'' Dart's comments were included in a release issued by Johnson & Johnson's McNeil unit, which sells consumer products. Johnson & Johnson rose 2 3/16 yesterday to 74 9/16. In November, the FDA said it planned to require the makers of all over-the-counter pain killers to add an alcohol warning to their labels. Johnson & Johnson, which already placed a voluntary warning on Tylenol, could benefit from the FDA proposal, which would put competitors that do not now have warning labels on their products on equal footing. Tylenol currently carries a warning similar to the FDA's proposed label, warning people who consume three or more alcoholic beverages daily to consult a doctor before using any pain medication. New Brunswick, New Jersey-based Johnson & Johnson, maker of Band-Aids, also sells the anemia drug Procrit and the schizophrenia drug Risperdal. --Kerry Dooley in the Princeton newsroom (609) 279-4016/dd