This is an old story, but a new one too. Tylenol and store-brand versions of acetaminophen (Tylenol’s active ingredient) are the leading cause of acute liver failure, leading to death or transplant, in the United States. That’s been known for a decade, thanks to pioneering work by Dr. William Lee of University of Texas-Southwestern Medical Center. The question is what to do about it, and that’s the new/old story.
Six years ago, an FDA advisory panel recommended that Extra Strength Tylenol (500 mg per pill) should lose its over-the-counter (OTC) status and be available only by prescription. That’s because of Tylenol’s narrow margin of safety. OTC drugs are supposed to be so safe that you can swallow a little more than the recommended dose and not worry about it. Not so with acetaminophen.
Twenty years ago, when I brought a lawsuit for a client of mine who lost his liver to ordinary doses of Tylenol — two tablets of Extra Strength Tylenol four times a day for several days, or four grams a day, the then recommended maximum daily dose — the McNeil Consumer Product subdivision of Johnson & Johnson fought our case hard. Impossible, McNeil said of our client’s injury. Four grams a day is absolutely safe, the company contended. (Our victory in that case was a bitter pill for plaintiff Tony Benedi, as the Washington Post reported back then.)