The Newly Toxic Tylenol

Liver from Gray's Anatomy, courtesy Wikimedia Commons

Liver from Gray's Anatomy, courtesy Wikimedia Commons

So as you’ve probably heard, our favorite go-to anti-pyretic has been dragged through the mud recently at an FDA hearing citing that it is the leading cause of acute liver failure in the US; that there are 42,000 hospitalizations annually for acetaminophen overdose, and these lead to between 200-400 yearly deaths, with many more ICU stays and liver transplants.

The committee supported a couple of changes to acetaminophen:

  • The adult dosage of 4g/day maximum should be lowered;
  • The 500mg tab PO x2 q6hr dosing should be prescription strength;
  • Pediatric liquid concentrations should be standardized;
  • Nix the acetaminophen combo tabs (goodbye my beloved vicodins and percocets)

Some interesting things to note:

  • Looking at the meeting roster, only two toxicologists on the panel and two emergency physicians. (Neither of the toxicologists, one being Lewis Nelson at NYU, chair of the committee, voted to reduce the daily maximum dosage of tylenol.)
  • The FDA says “Taking just a small amount of acetaminophen over the recommended total daily dose (4 grams per day) may lead to liver injury.” I certainly haven’t heard of this. Sure, there’s the 2g maximum if your patient drinks more than 60 grams of ethanol per day, but I certainly haven’t heard of toxicity at 5 grams per day. Even Goldfranks cites 7.5g/day in adults (150mg/kg) or 75mg/kg in kids. The FDA is basing this on reporting data, which I would guess is notoriously inaccurate. I’ll have to ask my tox colleagues for more information on this.
  • What are we calling liver injury? A bump in your LFTs, or true liver failure? Apparently you can have a rise in them from just 4g/day in this study.
  • One gastroenterologist makes a good point: so we reduce tylenol usage. Are we going to see an increased usage/overdose on NSAIDs with more gastritis and GI bleeds?
  • I’m all about better patient safety. YES, lets standardize pediatric dosages so my math-challenged brain can keep puttering along. YES tylenol is in practically everything over-the-counter, so much of our health illiterate population can unintentionally overdose. YES acute liver failure is BADNESS with a capital B and scared the heck out of me when my patient ingestion 500 extra strength tabs 2 days prior to arrival. BUT we also go through 24.6 BILLION (I’m going to repeat that, TWENTY FOUR POINT SIX BILLION with a capital B) doses of tylenol a year and have 42,000 hospital stays out of, what, several million?

    I just hope two things dont happen: one, that the god of unintentional consequences does not smite us with more narcotics or NSAID overdoses/complications (I can see vicoprofen flying off the shelves already), and two, we don’t start writing scripts for new formulations of narcotics that the drug companies somehow manage to patent and now cost our health care system 100 times more than our current less-than-perfect-but-so-is-everything solution.

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