FDA may change Tylenol warnings
WASHINGTON - Drug makers should limit doses and strengthen warnings on Johnson and Johnson's Tylenol and other medicines containing acetaminophen to reduce the risk of liver injury, according to a US report.
The recommendations are part of a working group's report posted yesterday on the Food and Drug Administration's website. Acetaminophen, used to reduce pain and fever, is sold as Tylenol, as a generic, and in certain combination products, such as Abbott Laboratories' painkiller Vicodin.
Liver injury, usually caused by unintentional overdose, has been a known risk of acetaminophen since the late 1990s, the FDA said.
The FDA doesn't want to discourage appropriate use of acetaminophen, according to the report, dated Feb. 26, 2008.
The agency has asked members of several advisory panels to meet June 29-30 to discuss the recommendations for prescription and over-the-counter medicines containing acetaminophen. 