U.S. wants prominent warnings on pain relievers

WASHINGTON (Reuters) -- U.S. health officials said on Tuesday they want more visible side-effect warnings on the packages of over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen.

Acetaminophen carries a risk of liver damage, while aspirin and other products called NSAIDs may cause stomach bleeding. Both complications occur in only a small fraction of patients, but can be deadly.

The risks have been known for years, but the U.S. Food and Drug Administration said new warnings could raise awareness among consumers and reduce deaths and injuries.

Tens of millions of Americans take over-the-counter drugs to relieve pain every year. FDA officials said the vast majority encounter no problems if they take recommended doses.

Experts worry, however, that people do not realize the dangers of taking too much or combining the medicines with alcohol. Or they may unknowingly use more than one product that contains the same ingredient and accidentally overdose.

"Consumers have to be more cognizant of what they're taking for pain relief," said Dr. Charles Ganley, the FDA's director of nonprescription drug products.

But consumer group Public Citizen said the FDA's action was "decades late," citing FDA panels that urged new warnings for acetaminophen in 1977 and 2002.

The FDA's Ganley said the effort took time because the agency had to complete a "laborious" process of writing new rules that would apply to all over-the-counter pain relievers.

NSAIDs, or nonsteroidal anti-inflammatory drugs, include aspirin, ibuprofen, naproxen and ketoprofen.

The NSAIDs and acetaminophen are available in generic and brand-name versions. Acetaminophen, for example, is the active ingredient in Johnson & Johnson's Tylenol. Wyeth sells ibuprofen under the name Advil. Bayer AG makes aspirin.

The ingredients are available in dozens of over-the-counter pain relievers, as well as some cough and cold remedies. Higher prescription doses are also sold.

Many makers of over-the-counter products voluntarily changed product labels after an FDA advisory panel recommended that in 2002. But agency officials said they wanted consistent language on all packages.

Ganley said it was hard to know exactly how many people experience serious side effects from the pain relievers. One manufacturer estimated about 200 unintentional deaths a year were linked to acetaminophen.

A widely cited 1999 study linked NSAIDs to 16,500 deaths per year. Ganley said most of the complications from NSAIDs was attributable to stomach bleeding in patients who take aspirin long-term to prevent heart problems.

The FDA proposed that acetaminophen products note the risks of liver damage are greatest if people take high doses or drink more than three alcoholic drinks a day.

For NSAIDs, the warnings should say the risk of stomach bleeding is highest in people who are over 60, are taking a blood thinner, or have had prior ulcers or stomach bleeding, the FDA said. The chances also increase when patients ingest more than one NSAID, drink three or more alcoholic drinks per day or take the product longer than directed, the FDA said.

The agency also would like the terms acetaminophen and NSAIDs displayed prominently on drug cartons. The proposal is open for comments for 90 days.

McNeil Consumer Healthcare, the Johnson & Johnson unit that sells Tylenol, said the company had already implemented some of the proposals and would "work with the FDA to ensure appropriate information is provided to consumers."

Wyeth also has updated its product labels, said Fran Sullivan of Wyeth Consumer Healthcare.

Date Posted: January 19, 2007