Tuesday, June 30, 2009

Government panel may pull drugs containing acetaminophen

A government panel assembled by the FDA may make some recommendations to pull some very common medications off the shelf. Acetaminophen (common brand name Tylenol) is a very safe drug that is mainly used to treat pain and fevers. However, an overdose of Tylenol can also be lethal because it can destroy the liver. We can live without our spleen, but we can't live without our liver, so that's why a Tylenol overdose can be fatal. Some people die as they wait for a liver transplant.

According to CNN (quoting the FDA), "overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s." Of course, we also know that millions of people safely use Tylenol without any problems. The advisory panel could vote to pull over-the-counter drugs that use acetaminophen in combination with other ingredients that treat flu and cold symptoms, allergies or sleeplessness. This includes common drugs like: NyQuil, Pamprin and Allerest. Does this just mean that consumers will learn how to use over-the-counter drugs for off-label purposes? The FDA doesn't have to follow the advisory panel recommendation, so when this is all over, it may all be meaningless.

CNN also reports that the Consumer Healthcare Products Association (CHPA) strongly opposes the elimination of OTC (over-the-counter) acetaminophen containing combination products. Interesting? Click here to read the CNN story.


  1. I am a bit confused ... Acetaminophen is suddenly at the top of the pile for "safety" review. And the FDA decides to take Percocet and Vicodin off the market (even though they are controlled by the safety "filter" called physicians). And the FDA is going to leave OTC acetaminophen on the market but in lower doses (even though the public knows how much the FDA used to let them take) which means that the public will just take more tablets to get the same total dose they are used to taking.

    Seems like the FDA would learn from history. Ibuprofen was only available by prescription ... but the FDA said it was ok to make 200mg tabs available as OTC. So what does the typical patient do? He/she takes 4 of the 200mg ibuprofen tablets per dose 4 times daily ... with nobody watching for adverse effects like kidney failure.

    But maybe the FDA will catch on and take ibuprofen prescription strength off the market and make the OTC preps available only in 100mg tablet strength ..... any bets?

  2. A few years back, Tylenol ran the ad campaign, "Stop, Think, Tylenol". Maybe a more appropriate one today would be "Stop, Re-Think, Tylenol".

  3. Well I hope none of these people get sick. My husband has terminal cancer and the only drug that takes the pain away is Vicodin. He is still able to work since Vicodin works so well. He takes it according to the doctors directions. How about stricter policies on prescribing this medication and not taking it off the market!

  4. Alec Beningfield, M.D.July 1, 2009 at 8:57 AM

    As a surgeon who prescribes these two products extensively for short-term postoperative use, I am really concerned about this development. It will be far more difficult to control postoperative pain for my patients without these medications. Acetominophen is definitely hepatotoxic, but there is no secret to safe use - just DO NOT prescribe excessive doses. I hate the broad-brush approach to a selective problem.

  5. Although acetaminophen is one of the most commonly used drugs in the United States for treating pain and fever, overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s, according to the FDA, citing one study.

    During the 1990's??? How many people fall off of a ladder over the course of a decade?

    ... the likely cause of most of the estimated 1600 acute liver failures each year. They say this just before Abbot is quoted as saying pain affects 75 million Americans.

    Word-smithing aside, these numbers are statistically irrelevant, which is probably why 17 of the 37 advisors didn't vote for eliminating them. On the other hand, Michael Jackson (who had been doing a pain control cocktail for 25 years) just died, so why not expect some sort of overreaction?

  6. Here's my question: why does Vicodin have acetaminophen in it in the first place? If physicians had uncombined hydrocodone available to prescribe (or do they already?), would they be able to relieve pain *better* without having to worry about liver damage?

    I actually read somewhere that the only reason acetaminophen was combined with opioids, as in Vicodin and Percocet, was as a deterrent to abuse. I don't seriously believe that, it sounds too much like conspiracy theory thinking and wouldn't work anyway, but it does raise the question: why the combination?


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