FDA News Release June 2009
An FDA Advisory Panel met in June 2009 to discuss options and future actions by the agency in regards to acetaminophen risks and addressing those risks by mandatory reduction in dosing, stronger and more informative warning labels, and removing products from the market.
FDA News Release June 2009
Acetaminophen toxicity is a leading cause of acute liver failure, resulting in an estimated 400 deaths and 56,000 ER admissions each year in the U.S. Acetaminophen is a common ingredient in a number of over-the-counter and prescription medications. Consumers should be provided with more information about the risks associated with acetaminophen including accidental overdose.
FDA New Release January 13, 2011
The FDA acted to reduce the dosage in prescription medications containing acetaminophen to 325mg per tablet and to require stronger liver toxicity warnings on all labeling. Because of continued reports of liver injury, FDA proposes that boxed warnings, the agency's strongest warning for prescription drugs, be added to all acetaminophen prescription products. This will be the first step in the agencies actions to increase consumer safety and to force drug manufacturers provide effective notice to consumers.
