Risks of Liver Damage and Death Form Basis for Concern
Johnson & Johnson has announced that, beginning in October, bottles of Extra Strength Tylenol sold in the U.S. will be accompanied by new warnings and instructions. The warning will make it explicitly clear that the drug contains acetaminophen, a pain-relieving ingredient that is the nation’s leading cause of sudden liver failure. According to data from the Centers for Disease Control and Prevention and the Food and Drug Administration, each year between 55,000 and 80,000 people are hospitalized for acetaminophen overdoses, and at least 500 people a year die from overdose.
The new instructions will reduce the maximum daily dose from 8 pills per day to 6 pills per day, and change the dosing interval from every 4 to 6 hours to every 6 hours. Johnson & Johnson’s website includes information about the proposed new instructions, but does not mention the risks of fatal acetaminophen overdose.
These changes come at a time when Johnson & Johnson is facing dozens of personal injury lawsuits that blame Tylenol for liver injuries and deaths. It is believed that each year, approximately 1 million Americans suffer liver damage from acetaminophen use, and many of those cases are preventable. In 2009, the FDA mandated that all acetaminophen products carry a warning about the risk of “severe liver damage” when not taken as directed. The FDA is now considering safety proposals that could curtail the use of acetaminophen products, including recommending elimination of the extra-strength formulation for over the counter versions.