The FDA Acetaminophen Advisory Committee Meeting – what is the future of acetaminophen in the United States? The perspective of a committee member

Abstract

Background. Unintentional acetaminophen toxicity is a common problem throughout the world but particularly in the more developed countries. To deal with the problem, several countries have attempted to decrease the risk of acetaminophen overdose by reducing package sizes. The U.S. Food and Drug Administration (FDA) convened a joint meeting recently of three Advisory Committees to consider the issue of unintentional acetaminophen-related toxicity and to explore strategies to address the problem. Proposals and recommendations. Three strategies addressed the issue of dose reduction as a way to decrease morbidity and mortality. The FDA proposed a decrease in the maximum daily dose from 4,000 to 3,250 mg, reducing the maximum individual dose from 1,000 to 650 mg and relegating 500 mg tablets to prescription status. The Committees voted in favor of each of those initiatives. Restricting the number of doses that could be purchased by regulating package sizes, as has been done in some European countries, was proposed, but rejected by the Committees. Proposals also addressed the elimination of nonprescription and prescription acetaminophen combination products (e.g., multi-symptom cold relief combinations and acetaminophen/opioid combinations) as a strategy to decrease unintentional poisoning when individuals unknowingly take different products, all of which contain acetaminophen. The Committees rejected the proposal to eliminate the nonprescription combinations but recommended the elimination of prescription combination products. Currently, liquid acetaminophen is available in the United States in three different concentrations. To reduce the confusion associated with the variance in concentrations the Committees voted to have a single concentration for all acetaminophen liquid products. Finally, the Committees voted, almost unanimously, to encourage the FDA to place a boxed warning in the product information to create awareness among prescribers and pharmacists about acetaminophen toxicity and to educate their patients accordingly. Conclusions. Many of the recommendations were not evidence-based but instead have an anecdotal basis. However, the Committees are advisory to the FDA, their recommendations are not binding and it remains to be seen which of the recommendations will be implemented.

Keywords:

• Acetaminophen
• Paracetamol
• Food and Drug Administration