opioid medication

FDA Advisory Panel Recommends Banning Vicodin and Percocet

Karen Lee Richards Health Guide June 30, 2009
  • You've probably been hearing in the news that an FDA advisory panel has recommended lowering the maximum recommended dose of acetaminophen from 1,000 mg per dose to 650 mg. They also recommended lowering the maximum daily dose, which is currently 4 grams (4,000 mg).  Although they didn't specify what the maximum daily dose should be lowered to, it would most likely be in the neighborhood of 2,600 mg per day.  The reason the FDA is considering changing their recommendations is that acetaminophen overdose is currently the leading cause of liver failure in the U.S.  

    What many news reports are not telling you, though, is that this same advisory panel, by a narrow margin, also recommended banning hydrocodone and oxycodone products like Vicodin and Percocet that contain acetaminophen.  (Vicodin and its generic counterparts contain hydrocodone and acetaminophen.  Percocet and its generic formulations contain oxycodone and acetaminophen.)  According to a 2005 study, most acetaminophen poisonings occurred in patients who were taking an opioid medication that also contained acetaminophen.  


    I suspect at least part of that problem may be because often patients are not aware that their pain medication contains acetaminophen.  Because they don't know, they may also take over-the-counter Tylenol or a cold/flu remedy that also contains acetaminophen, which could then result in an overdose.

    If you take one of these medications, before you panic, there are three things you should be aware of:

    1)  The FDA is not required to take the recommendation of the advisory panel, although they usually do.  Since the vote to ban Vicodin and Percocet-type drugs was so close, perhaps they will give it some extra consideration.

    2)  Being a government bureaucracy, even if the FDA accepts the panel's recommendations, it's likely to be quite a while until it is implemented.  It could be a year or two, or even more, before you will actually have to change your medication.

    3)  Although the combined forms of the medications may not be allowed, if your doctor feels you need acetaminophen with your oxycodone, the acetaminophen will still be available for purchase over-the-counter or by prescription and can be taken at the same time.  Hydrocodone may be more problematic since currently it's only available as a combination drug with either acetaminophen or ibuprofen.  Hopefully, if this recommendation becomes reality, pharmaceutical companies will start manufacturing hydrocodone by itself.  

    Personally, I'm not convinced banning these drugs will make a significant difference in the number of acetaminophen overdoses.  On the other hand, as long as both components of the medications are still available and the only difference is taking two tablets instead of one, it might help make patients more aware of what they're actually taking so they don't unintentionally get an overdose of acetaminophen.  

    What do you think?