New warnings on bottles of Extra Strength Tylenol will appear in October after reports of health complications and death, New York Daily News reported.
The move by Tylenol producer Johnson & Johnson follows a growing number of lawsuits and pressure from the federal government to notify the millions of consumers in the U.S. who take the medication everyday.
Johnson & Johnson said the new warning will appear on top of the Extra Strength Tylenol bottle caps by October as well as other bottles within the next few months. The warning is intended to remind users of acetaminophen, the pain killer ingredient, that has been causing liver failures across the country.
The label will say "CONTAINS ACETAMINOPHEN" and "ALWAYS READ THE LABEL."
"We're always looking for ways to better communicate information to patients and consumers," said Dr. Edwin Kuffner, vice president of McNeil Consumer Healthcare, the part of Johnson & Johnson that produces Tylenol.
According to the Centers for Disease Control and Prevention and the Food and Drug Administration, acetaminophen overdoses kill 500 people and send 55,000 to 80,000 people to the emergency room each year.
The pain-killing ingredient is also found in more than 600 over-the-counter products like Nyquil cold medicine, Excedrin pain tablets, and Sudafed sinus pills. Of all the products that include the ingredient, Tylenol is the first to include a warning label, which McNeil said is a result of the misuse of Tylenol by consumers.
So far, Johnson & Johnson faces more than 85 lawsuits over the commonly used drug that blames Tylenol for liver injuries and death. Although the company does not report sales of Tylenol, retail data service Information Resources Inc. estimated all products containing acetaminophen brought in $1.75 billion last year.
According to most health experts when used properly -- which means taking eight pills or less a day -- Tylenol is not harmful.
"The argument goes that if you take acetaminophen correctly you will virtually never get into trouble," said Dr. William Lee of the University of Texas Southwestern Medical Center, who has analyzed the toxicity of acetaminophen for 40 years. "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."
