Advertisement

Silver Spring, Maryland, Sept. 19 (Bloomberg) -- Johnson & Johnson, the world's biggest seller of over-the-counter medicines, will change the U.S. labels for its Tylenol painkiller to emphasize that an overdose can cause liver damage.

Johnson & Johnson announced the move hours before a panel of government advisers voted to recommend that the U.S. Food and Drug Administration require stronger warnings on acetaminophen, the main ingredient in Tylenol. Generic makers of the product would also be required to make changes if the FDA agrees.

"We will modify it further so that it says, 'Taking an overdose may cause liver damage,'" Anthony Temple, one of the chief medical officers for Johnson & Johnson's McNeil unit, told the FDA panel. "We think others in the industry should follow."

Acetaminophen products already carry cautions that they may damage the liver when combined with alcohol. Consumers raise the risk when they take more than the recommended dose, perhaps by using another product that contains the drug. Panel members suggested companies list acetaminophen as an ingredient in larger type and mention it on the front of the bottle.

The committee is meeting today and tomorrow to discuss the safety of painkillers available without a prescription. One of the concerns is that people may not realize they are taking so much of one medicine. Tylenol products, for instance, include cold pills and sleep aids as well as the standard painkiller.

Supermarket Sight

"It seems obvious to me, from a labeling point of view, that someone should be able to buy something in the supermarket and know what's in it," said Nathaniel Katz, a doctor from New Rochelle, New York who serves on the panel.

Sales at Johnson & Johnson's McNeil unit, which also sells Motrin-brand ibuprofen and St. Joseph aspirin, rose 4 percent to $862 million in the first six months of 2002. Tylenol is the division's biggest product. Pfizer Inc. and Bayer AG also sell products containing acetaminophen.

"It's a nice business for J&J," said Marty Bukoll, an analyst with Northern Trust, which holds about 24 million Johnson & Johnson shares, according to regulatory filings. "I would suspect Tylenol has about 90 percent gross profit margins," making it comparable to the income generated by a prescription medicine, he said.

Johnson & Johnson officials couldn't immediately say when the new warning would be added to Tylenol packages.

Shares Fall

Shares of New Brunswick, New Jersey-based Johnson & Johnson fell $1.89, or 3.5 percent, to $51.96 as of 4:17 p.m. in New York Stock Exchange composite trading.

The FDA has said acetaminophen, available without prescription since 1960, and other over-the-counter painkillers such as ibuprofen are safe. The agency is looking for ways to prevent some of the rare cases of severe side effects.

Accidental acetaminophen overdoses kill about 100 people a year, the FDA said. About 10 percent of 1999 calls to poison- control centers were related to acetaminophen overdoses.

Kate Trunk of Fort Myers, Florida, asked the panel to demand that the agency require stronger warnings on acetaminophen. Her 23- year-old son, Marcus, died in 1995 because of an accidental acetaminophen overdose.

Marcus took an over-the-counter acetaminophen product after running out of a prescription version of the medicine, which a doctor gave him for a wrist injury, Trunk told the panel. He soon after took another product with acetaminophen to treat the flu.

"The biggest thing is to tell the truth to the consumers and let them know there are potential problems," Trunk said. "Death is not an acceptable side effect."

The consumer group Public Citizen suggested the FDA also consider ways to make intentional overdoses with acetaminophen less dangerous. Many people stage suicide attempts as a means of seeking help with psychiatric problems.

The panel tomorrow will look at the safety of ibuprofen, aspirin and other painkillers.