(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.
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 take too much of such drugs.
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 painkillers such as cold medications.
Some companies have already revised their products with new warnings, Holman said, adding that all companies concerned must change their packaging by next April.