An FDA advisory committee will convene in late June to consider the report submitted by The Acetaminophen Hepatotoxicity Working Group, Center for Drug Evaluation and Research, Food and Drug Administration, Department of Health and Human Services, on February 26, 2008.
Editor’s notes: Acetaminophen is paracetamol (panadol). For the 500mg tablets in Hong Kong, it means that the maximum dose is suggested to be around 2 tabs tds (3000 mg) instead of 2 tabs QID (4000 mg). The comments are about over-the-counter acetaminophen, but the dosage recommendations may still apply to critically ill patients. Please comment.
The working group’s report, released online Wednesday 27 May 2009, is summarised below. For over-the-counter acetaminophen, the working group recommends, among other actions:
– using stronger warnings on the drug’s label;
– limiting the single adult dose to a maximum of 650 mg (slightly more than 1 tablet);
– lowering the maximum daily dose for adults from 4000 mg (8 tablets) to no greater than 3250 mg (slightly more than 6 tablets. and less than that for chronic alcohol users);
– limiting immediate-release tablet formulations for adults to 325 mg;
– restricting pediatric liquid formulations to a single mid-strength concentration;
– eliminating acetaminophen from combination products (no more dologesic, panadol cold, etc)
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Download the full report at the FDA here.