FDA report urges strong acetaminophen warning
May 28, 2009
FDA report urges strong acetaminophen warning
On May 27, 2009, the Food and Drug Administration (FDA) released a report recommending stronger warnings and dose limits on drugs containing acetaminophen, citing an increased risk of liver injury.
The recommendations are part of a working group report posted on the FDA's Web site. Acetaminophen, used to reduce pain and fever, is sold as Tylenol, as a generic, and in certain combination products, such as the painkiller Vicodin.
The recommendation covers both prescription doses and over-the-counter medication, of which Johnson & Johnson's Tylenol is the best-known.
Acetaminophen overdose, usually accidental, is a leading cause of acute liver failure in the United States.