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FDA Panel Recommends Acetaminophen Restrictions. Elimination of Some Prescription Drugs, Changes in OTC Products Possible
American Family Physician, 07/14/09

Mitchell D - An FDA advisory panel has recommended that the agency remove prescription drugs that combine acetaminophen and powerful painkillers - such as Percocet, which is formulated with oxycodone, and Vicodin, which is formulated with hydrocodone - from the market because of the risk of liver injury associated with misuse of the products. The panel also voted to lower dosage recommendations for over-the-counter, or OTC, acetaminophen products.

The FDA panel recommended two options if the agency allows the combination prescription products to stay on the market. In a 27-10 vote, the panel recommended that "unit-of-use" packages be required, and in a 36-1 vote, it recommended the FDA require a boxed warning for such products.

FDA's panel also made several recommendations related to acetaminophen-containing OTC products:

• by a 21-16 vote, it recommended that the maximum total daily dose, which is currently 4 grams, be lowered in both single-ingredient and combination products;
• by a 24-13 vote, it recommended that the maximum single adult dose be lowered to 650 mg;
• by a 26-11 vote, it recommended that if nonprescription single doses are lowered, the current maximum single dose (1,000 mg) should be switched to prescription strength; and
• by a 36-1 vote, it recommended that only one concentration of liquid acetaminophen should be available.

Manufacturers, however, might not be lining up to cooperate. McNeil Consumer Healthcare, which markets Tylenol, posted a letter to health care professionals objecting to the panel's recommendations to reduce the maximum single dose of OTC acetaminophen to 650 mg and to make the 1,000 mg dose available only by prescription. They believe the committee's recommendations, if implemented, will lead to serious and more frequent adverse events if patients shift to other OTC analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs).

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