US Food and Drug Administration Concerns Regarding Acetaminophen Toxicity

RADM Sandra Kweder, MD

Deputy Director, Office of New Drugs
Drug Evaluation and Research
US Food and Drug Administration

Acetaminophen is a widely used analgesic found in a number of over-the-counter and prescription products. Despite its benefits for mild to moderate pain, unintentional acetaminophen toxicity represents a growing public health problem. In particular, acetaminophen overdose commonly causes hepatotoxicity, potentially leading to acute liver failure. In fact, acetaminophen is the most common cause of acute liver failure in the United States, and the incidence is increasing. In 2009, the US FDA convened a joint meeting of the Drug Safety and Risk Management Advisory Committee, the Anesthetic and Life Support Drugs Advisory Committee, and the Nonprescription Drugs Advisory Committee to provide advice on strategies to reduce liver complications related to the use of over-the-counter and prescription products containing acetaminophen. The committees evaluated proposals to enhance public education efforts, improve labeling on acetaminophen-containing products, define appropriate dosing in children, and potentially eliminate combination products. Here, David Simpson, MD and RADM Sandra Kweder, MD discuss the FDA’s efforts to ensure proper acetaminophen use and reduce the potential for unintentional acetaminophen overdose from various prescription and/or nonprescription products.

References

Chun LJ, Tong MJ, Busuttil RW, Hiatt JR. Acetaminophen hepatotoxicity and acute liver failure. J Clin Gastroenterol. 2009;43(4):342-349.
Krenzelok EP. The FDA Acetaminophen Advisory Committee Meeting—what is the future of acetaminophen in the United States? The perspective of a committee member. Clin Toxicol (Phila). 2009;47(8):784-789.
Toms L, McQuay HJ, Derry S, Moore RA. Single dose oral paracetamol (acetaminophen) for postoperative pain in adults. Cochrane Database Syst Rev. 2008;(4):CD004602.

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