Acetaminophen, found in more than 600 over-the-counter products like Johnson & Johnson's ($JNJ) popular Tylenol, is an effective nonaspirin pain reliever. Take enough of it, however, and it will kill you. That is a fact that has troubled the FDA, which has pushed makers to do more to warn consumers they have to be careful. J&J, which two years ago said it was looking at adding warnings to Tylenol bottle caps, is now doing that.
According to the Associated Press, starting in October bottles of Extra Strength Tylenol will have caps that read "contains acetaminophen" and "always read the label." The labels will make clear that acetaminophen is the leading cause of sudden liver failure. Up to 80,000 people overdose on acetaminophen a year, the FDA says, and about 500 cases are fatal.
Extra Strength Tylenol is potentially the most dangerous because it contains 1,000 mg of the active ingredient in a two-pill dose, compared with 650 mg in the regular strength. J&J's McNeil Consumer Healthcare unit, which makes the drug, will add the new caps to the rest of the Tylenol brands in coming months, the news service said.
"We're always looking for ways to better communicate information to patients and consumers," Dr. Edwin Kuffner, vice president of McNeil Consumer Healthcare, told the AP.
Acetaminophen toxicity has been a long-running issue. The FDA has a web page devoted to the subject. Two years ago, J&J revamped its Tylenol product line for infants and children, standardizing the dosing so that parents made fewer errors, as did several generics makers that sell private-label versions. Johnson & Johnson was sued last year by a couple whose 2-year-old died of liver failure after being given Children's Tylenol.
In 2011 the company announced it was also changing the dosing instructions on Extra Strength Tylenol from 8 pills a day to 6. It said it was done "to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose." At the same time, McNeil said it was working on the new messaging for caps on Extra Strength Tylenol and expected to begin using it in 2012.
While the new caps are said to be for the U.S. market, the company has run afoul in other markets over problems with acetaminophen dosing. Authorities in South Korea launched an investigation in May after they learned that a J&J Janssen unit continued to sell Children's Tylenol that may have contained more than the labeled amounts of acetaminophen in them. While no adverse reactions were reported, regulators there were concerned that it took a month for the operation to notify them of the potential problem. They were considering criminal charges in the case.
- read the AP story
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