Acetaminophen, or Tylenol, is one of the most commonly used drugs to reduce pain and fever; when consumed in large amounts, however, it could lead to liver failure and even death. Johnson & Johnson, the company producing Tylenol, has decided to add a warning to Tylenol caps that they hope will prevent such fatal overdoses.
The new cap message, which will label Tylenol bottles starting in October, will read: “Contains acetaminophen” and “Always read the label.”
The decision to add a cap label comes at a time when Johnson & Johnson and its McNeill subsidiary are facing around 85 personal injury lawsuits in federal court -- which claim that Tylenol caused liver problems and death -- and that the company failed to warn consumers.
The Centers for Disease Control and Prevention (CDC) and the FDA state that acetaminophen overdoses cause between 55,000 and 80,000 people to rush to the emergency room per year. There are around 500 acetaminophen overdoses leading to death that occur annually, half of which are reportedly accidental, and the others suicides.
The FDA is also currently coming up with new safety proposals regarding Tylenol in the hopes of curbing its use.
"The argument goes that if you take acetaminophen correctly you will virtually never get into trouble," Dr. William Lee of the University of Texas Southwestern Medical Center told USAToday. "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."
During an acetaminophen overdose, the liver produces a toxin that destroys cells – ultimately leading to liver failure, which is fatal. The product causing concern is the highly popular version of Tylenol known as "extra strength," which contains 1,000 milligrams of acetaminophen versus the 650 milligrams for regular pills. Such pill bottles contain a large number of pills that are packed with acetaminophen, and consumers may assume they are perfectly safe to "pop" frequently to fight pain, as Tylenol has always been marketed as a very safe product. However, taking more pills than advised or mixing Tylenol with alcohol, Nyquil or other painkillers is where the liver problems can set in.
Overall, the percentage of people who are fatally harmed by Tylenol is very small, and acetaminophen is found in hundreds of other over-the-counter drugs like Nyquil and Sudafed as well. But Tylenol will be the first to label its caps with this message. "We're always looking for ways to better communicate information to patients and consumers," Vice President of McNeil Consumer Healthcare Dr. Edwin Kuffner said.