Panel Urges Tougher Warnings for Acetaminophen

By Lisa Richwine

SILVER SPRING, Md. (Reuters) - U.S. advisers on Thursday recommended stronger warning labels on medicines containing acetaminophen, a pain reliever found in dozens of over-the-counter products, to keep people from taking excessive doses that can damage the liver and in rare cases kill.

Acetaminophen, used by millions of Americans, is the active ingredient in Johnson & Johnson's Tylenol. It also is found in other brand-name and generic products, including cough and cold remedies, and in some prescription drugs. It goes by the name paracetamol in many countries, including Britain.

Labels on Tylenol packages already have been revised to help ensure safe use, Johnson & Johnson said.

Acetaminophen is very safe when taken as directed, regulators said. But they are concerned that patients either are unaware of or ignore the recommended maximum doses. Also, consumers may unknowingly take several products with acetaminophen, possibly ingesting more than what is considered safe. High doses may damage the liver.

Product packaging should convey the message that "this is not a benign product, and the recommended dose is the recommended dose," said Dr. Eric Brass, a member of a Food and Drug Administration advisory panel.

Panel members suggested placing the word acetaminophen in large type on the front of packages as well as on all bottles, and strengthening and clarifying current warnings to highlight the liver risk. Some said current labels wrongly imply that liver disease is only a risk for people who drink alcohol.

Kate Trunk said her 23-year-old son, Marcus, took acetaminophen products after injuring his wrist and died. She urged better efforts to educate consumers about the drug's dangers. "Death is not an acceptable side effect," she told the panel.

Others cautioned against making the warning too strong. "We don't want to make Tylenol look like a dangerous product," said panel member Dr. Nathaniel Katz.

An FDA analysis estimated there are about 100 U.S. deaths, and more than 13,000 emergency room visits, each year from unintentional acetaminophen overdoses.

The current maximum recommended dose is four grams, or 4,000 milligrams, per day.

Drug makers stressed that millions of people around the world take acetaminophen without suffering harm.

"Acetaminophen is one of the safest drugs available when taken as directed ... Instances of serious harm are rare," said Debra Bowen, a vice president for McNeil Consumer and Specialty Pharmaceuticals, a Johnson & Johnson unit.

Packaging for Tylenol, Tylenol Cold and other McNeil products now prominently display the word acetaminophen and a warning against taking other products with the same ingredient at the same time. The company also plans to include a statement explaining that acetaminophen overdoses may damage the liver, Bowen said.

Panel members said the changes were welcome improvements.

The FDA usually follows its panels' advice and will consider the recommendations as part of a review of the safety of over-the-counter painkillers. On Friday, the FDA panel will debate whether steps can be taken to prevent stomach bleeding and other side effects from aspirin, ibuprofen and other pain relievers.

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