OTC pain drugs to carry more prominent U.S. warnings

WASHINGTON (Reuters) - Over-the-counter pain relievers such as Tylenol and Advil will carry bolder warnings about the risk of liver damage or stomach bleeding, the U.S. Food and Drug Administration said on Tuesday.

A customer leans against a pharmacy counter in a file photo. REUTERS/Jessica Rinaldi

Products containing acetaminophen, such as Johnson & Johnson’s Tylenol, will carry a prominent package warning about the risk of severe liver damage if, for example, people took too much of the drug.

Painkillers known as non-steroidal anti-inflammatory drugs, or NSAIDS, including Bayer AG’s aspirin products, Wyeth’s Advil and Johnson & Johnson’s Motrin, will carry bold warnings about the risk of stomach bleeding, the FDA said.

“We believe the new labeling requirements will add information concerning severe adverse effects of over-the-counter pain relievers and fever reducers that many consumers may not be aware of,” said Matthew Holman, the FDA’s deputy director for the Division of Nonprescription Regulation Development.

The new rules, first proposed in late 2006, also apply to generic drugs and other nonprescription products that contain the painkilling ingredients, such as cold medications.

While the risks with these kinds of drugs have been known for years, FDA’s Holman said it is important to better highlight them for consumers, who could unknowingly take multiple products containing acetaminophen.

The new warnings will also point out the increased risk of liver damage with acetaminophen in consumers who drink three or more alcoholic drinks each day. They also call on consumers taking the widely used blood thinner warfarin to consult their doctors before taking acetaminophen products.

Some companies have already revised their products’ packaging to add some of the new warnings, Holman said, adding that all companies concerned must change their packaging by next April.

In a statement, Johnson & Johnson’s McNeil Consumer Healthcare unit, which makes Tylenol and Motrin as well as St. Joseph Aspirin, said it would make the labeling changes as requested.

Wyeth spokeswoman Linda Mayer said the company was aware of the FDA announcement and would comment soon. A representative for Bayer could not be immediately reached.

The FDA’s announcement comes ahead of a public FDA meeting in late June to discuss what other actions the agency could take to curb the risk of liver damage from products containing acetaminophen.

The risk of liver damage or stomach bleeding with over-the-counter pain medications spurred the development of prescription pain drugs known as COX-2 inhibitors.

But those drugs -- which included two now withdrawn drugs, Pfizer Inc’s Bextra and Merck & Co Inc’s Vioxx -- carried their own set of safety concerns, such as an increased risk of heart attacks and other cardiovascular problems. Only Pfizer’s Celebrex remains on the U.S. market.

Reporting by Susan Heavey; Editing by Tim Dobbyn and Gerald E. McCormick