An FDA panel in the guise of protecting the public has made a recommendation that on reflection they’ll wish they hadn’t. They issued numerous advisories concerning acetaminophen (the most familiar form of this drug is Tylenol) alone and in combination with other drugs. I’ll just concentrate on their recommendation concerning acetaminophen used by itself. Their concern was that used inappropriately the pain killer can cause liver failure.
Acetaminophen is a very effective drug for chronic pain. In this context it’s used most often by patients with degenerative joint disease (DJD) also known as osteoarthritis. The usual dose for patients with DJD is 4 grams a day (1 gm four times daily). At this dose the drug is one of the safest on the market; it’s far safer than aspirin. Unlike non-steroidal anti-inflammatory drugs (NSAIDs) its easy on the GI tract and the kidneys. Unless you drink a lot of alcohol while taking acetaminophen at this dose you will not get liver disease from it. Liver injury occurs only when patients take more of the drug than advised. I always told my patients not to take any other drug that has acetaminophen in it when on a scheduled dose of the drug. Nephrologists typically tell their patients with pain to avoid NSAIDs and take acetaminophen for relief.
The committee voted 24 to 13 to recommend that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams from 500. And its members voted 21 to 16 to reduce the maximum daily dosage to less than 4,000 milligrams; they didn’t say what the daily dose should now be. Why would they advise that the FDA change the label from the right dose of the drug to an unspecified inadequate dose while making it harder for people to take four grams (which is safe) a day because 500 mg tablets would no longer be available?
This is clearly the triumph of paternalism over science. The thinking, deranged in my view, is that if you tell people to take less than 4 gm a day they’ll pop more than advised and get to 4 gm. If the label says 4 gm they’ll gobble even more and shut down their livers. The panel majority didn’t say how many cases of acetaminophen induced liver disease occurred because patients ignored the label and took more drug hoping for more pain relief compared to how many took a lot of acetaminophen as a suicide attempt or gesture.
Consider this scenario. The daily dose on the label is reduced (the committee obviously knew they were doing mischief as they didn’t say what the new dose should be). A doctor tells his patient to take 4 gm daily. The patient does and subsequently gets liver disease unrelated to acetaminophen. The patient blames the liver disease on the doctor because he advised a dose greater than that on the label. Trial lawyers here we come.
Some may argue that the 500 mg dose of acetaminophen should be available by prescription. Generic acetaminophen is almost dirt cheap. Make it prescription only and its cost will increase dramatically.
This part of the acetaminophen recommendations is foolish, poorly reasoned, and should be ignored. But I don’t have much hope that the FDA will ignore it. Life is going to get a little harder for patients who have chronic pain and for the doctors who care for them. Why the FDA panel decided to tilt at this windmill when there are so many better things they could be doing is as mysterious as a dean’s committee.