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FDA Working Group Recommends Revising Acetaminophen Dosing, Labels

Patients may ask about reports that an FDA working group has recommended making changes to acetaminophen labeling and dosing to attempt to decrease acetaminophen-induced liver damage.

An FDA advisory committee will convene in late June to consider the working group's report, released online Wednesday. 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;
  
• lowering the maximum daily dose for adults from 4000 mg to no greater than 3250 mg (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.
  

LINK(S):

Associated Press story (Free)

Working group's recommendations (Free PDF)

Published in Physician's First Watch May 28, 2009

Reader Remarks:

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• APAP dosing
  CM Kolly, 2 Jul 2009 2:04 PM EST
  What about the 15mg/kg dose for peds? I haven't seen anything about this.... Regardless, I am not so sure a... [more]