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.)
Then in 2011, McNeil dropped the recommended daily dose to six tablets a day, or three grams.
It’s now clear that McNeil was trying to fend off the more drastic recommendation of the FDA advisory panel that Extra Strength Tylenol is too dangerous to stay an OTC drug.
Which brings us to today’s news: A lawsuit is starting trial in Atlantic City, New Jersey today, that has helped a ProPublica investigative reporting team led by Pulitzer winner Jeff Gerth uncover documents from McNeil and J&J about a lobbying strategy the company put together after the 2009 advisory panel’s recommendation. The goal was to “save Extra Strength Tylenol,” as the internal documents put it.
It’s not clear exactly what the company did, but it must be working, because six years later, the recommendation of the FDA panel remains unexecuted, in legal limbo.
Dr. Will Lee wrote this about acetaminophen in 2004 in a medical journal focusing on liver diseases. The statistics are a bit old, but his question remains fresh:
Acetaminophen overdose is the leading cause for calls to Poison Control Centers (>100,000/year) and accounts for more than 56,000 emergency room visits, 2,600 hospi- talizations, and an estimated 458 deaths due to acute liver failure each year. Data from the U.S. Acute Liver Failure Study Group registry of more than 700 patients with acute liver failure across the United States implicates acetaminophen poisoning in nearly 50% of all acute liver failure in this country. Available in many single or combination products, acetaminophen produces more than $1 billion dollars in annual sales for Tylenol products alone. It is heavily marketed for its safety compared to nonsteroidal analgesics. By enabling self- diagnosis and treatment of minor aches and pains, its benefits are said by the Food and Drug Administration to outweigh its risks. It still must be asked: Is this amount of injury and death really acceptable for an over-the-counter pain reliever?