Bottles of Tylenol sold in the United States will soon bear red warnings alerting users to the potentially fatal risks of taking too much of the popular pain reliever.
The warning, to be placed on the cap of the bottle, will make it explicitly clear that the over-the-counter drug contains acetaminophen, a pain-relieving ingredient that’s the nation’s leading cause of sudden liver failure.
The move comes at a critical time for the company, which faces more than 85 personal injury lawsuits in federal court that blame Tylenol for liver injuries and deaths. At the same time, the Food and Drug Administration is drafting long-awaited safety proposals that could curtail the use of Tylenol and other acetaminophen products.
Each year, some 100 million Americans use acetaminophen, but liver damage occurs in only a fraction of 1 percent of users. Still, liver specialists say those cases are preventable. They say that part of the problem is that there are sometimes hundreds of pills in a bottle, making it easy for consumers to pop as many as they please. For example, McNeil sells Extra Strength Tylenol in bottles containing up to 325 tablets.
“The argument goes that if you take acetaminophen correctly you will virtually never get into trouble,” says Dr. William Lee of the University of Texas Southwestern Medical Center, who has studied acetaminophen toxicity for four decades. “But it’s the very fact that it’s easily accessible over-the-counter in bottles of 300 pills or more that puts people in harm’s way.”