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Update on acetaminophen

AUG 2009

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After the August 2009 issue went to press, an FDA advisory panel made several recommendations regarding acetaminophen at its June 29-30 meeting.

Although this is an important step, it’s not the final word: the FDA isn’t required to follow the advice of its advisory committee, which are made up of outside experts.

The agency is expected to make a final decision on the acetaminophen recommendations some time in the next several months. And, naturally, there will be some lag before any changes are implemented.

Here are some of the highlights of the advisory panel’s recommendations:

  • Remove prescription drugs that combine acetaminophen with powerful painkillers, which would include Percocet, a combination of acetaminophen and oxycodone, and Vicodin, a combination of acetaminophen and hydrocodone. The vote was close, 20–17, and it’s possible the agency will allow these combination pills to stay on the market but with stronger warnings.

  • Lower the maximum single adult dose from 1,000 mg to 650 mg. Over-the-counter acetaminophen often comes as 325-mg pills, so people would be told to take no more than two pills at a time.

  • Make the 500-mg, which is currently available over the counter, into a prescription-only product

  • Lower the maximum daily dose from 4,000 mg. The panel did not recommend a new daily maximum. But if you “do the math” with the maximum dose of 650 mg, to be taken every 4–6 hours, the new maximum daily works out to be between 2,100 mg (3, 650-mg pills taken 6 hours apart during 18 waking hours) and 2,600 mg (4, 650-mg pills taken 4 hours apart during 16 waking hours).

  • Set a single concentration for the liquid acetaminophen.

The advisory panel voted against several proposals, including one that would have banned over-the-counter products that combine acetaminophen with other drugs and set some restrictions on packaging.