FDA Proposes Acetaminophen Liver Warnings--June 2009


Members of the FDA's advisory panel will meet at the end of June to discuss the agency's working group report that calls for stronger warnings and dose limits on prescription and OTC products containing acetaminophen to reduce the risk of liver injury.

"There is extensive evidence that hepatotoxicity [liver toxicity] caused by acetaminophen use may result from lack of consumer awareness that acetaminophen can cause severe liver injury," according to the report.

The working group, made up of 12 top officials in the FDA's Center for Drug Evaluation and Research, recommends 6 options:

  • Lower immediate-release tablet strength to no more than 325 mg from the current 500 mg and reduce the single adult dose to 650 mg, from 1000 mg. Decrease the maximum daily dose of all acetaminophen to 3250 mg from 4000 mg.
  • Establish package size limits for OTC acetaminophen products.
  • Require unit-of-use packaging for prescription products.
  • Expand product warning information on Rx products.
  • Eliminate combination OTC and/or Rx products that contain acetaminophen.
  • Limit the dosing formulation for OTC liquid products and require dosing device.

Acetaminophen-related liver injury was the leading cause of acute liver failure from 1998 to 2003. Analyses of national mortality data show that acetaminophen-associated overdoses account yearly for 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths, according to the FDA report

The Consumer Healthcare Products Association said it "looks forward to working with the FDA and other interested parties to further build awareness among consumers about how to safely and effectively use acetaminophen."

For a related article, see:

New Labels Coming for OTC Painkillers

For other articles in this issue, see:

Pharmacy Groups: Proper Med Use Key in Health Care Reform

Nevada Law Allows Pharmacists to Help Combat Diabetes

Helping Clinicians Improve Cancer Care

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