Thursday, July 9, 2009

FDA on APAP & Propoxyphene

1.
An FDA advisory committee has recommended restricting acetaminophen on a variety of fronts (WebMD story here). Read the story, which is brief, for the details. Remember this is a committee recommendation, not FDA policy yet. Major points are:

  • All this seems to be based in the context of the reality of too-many APAP associated inadvertant overdoses leading to liver failure.
  • The committee recommending reducing the 4 gram/day max dose for adults, as well as limiting the maximum one-time dose to 650 mg.
  • They also recommended discontinuing all (yes, apparently all) combination products containing APAP. The news article discusses mostly opioid combinations, and it's unclear if non-prescription combination products are targeted as well (e.g. cough/cold remedies, etc.). The basic idea, and probably most of us have seen cases like this, is that patients may inadvertantly overdose on acetaminophen if they are in a lot of pain and take more than prescribed.

Part of me thinks this is reasonable; I've pulled back for a while now on prescribing 4 grams a day of APAP. The suspicious/paranoid part of me worries this is a back-door stragegy to restrict access to opioids.

2.

The FDA has also put a 'black box' warning on propoxyphene products, as opposed to banning them outright as had been considered earlier.

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