New Tylenol warnings will use a bright red cap to alert consumers of the risks of fatal liver failure, the boldest warning yet from drug maker Johnson & Johnson.
The company announced that it will be adding red warning caps to Extra Strenght Tylenol starting in October, a new larger precaution for consumers that acetaminophen has been linked to liver failure.
Research has found that acetaminophen overdose is the leading cause of liver failure in the United States. The Food and Drug Administration has already taken action to cut the amount of acetaminophen allowed in prescription drugs to 325 milligrams per pill. Over-the-counter Extra Strength Tylenol contains 500 milligrams, according to its label.
The new Tylenol warnings come just weeks after the Food and Drug Administration took steps to warn consumers about the risks of over-the-counter drugs that contain acetaminophen. The warning, which will also appear on prescription bottles, states that people taking the drug are at risk of a dangerous skin reaction.
Dr. Sharon Hertz, deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction, said that the new warning isn’t meant to scare people away from the drug but instead inform them of all of the risks.
“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications,” Hertz said. “However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious side effects, which are potentially fatal.”
Tylenol has tweaked its products in recent years after reports of acetaminophen risks. In 2011, the drugmaker eliminated Tylenol infant drops, a highly concentrated formula linked to accidental overdoses. Tylenol also changed directions on Extra Strength Tylenol from “take 2 caplets every 4-6 hours while symptoms last” to “take 2 caplets every 6 hours while symptoms last.”
The new Tylenol warnings will read “Contains Acetaminophen” and “Always Read The Label,” the Associated Press reported.