Changing winds: practice implications of acetaminophen regulations

Abstract

The Food and Drug Administration (FDA) convened a joint meeting of 3 advisory committees in June 2009 to review and propose recommendations for reducing the incidence of acetaminophen-induced liver injury. The committee voted in favor of 7 of the 9 recommendations that will be taken to the FDA for executive review and action. The actions supported by the committee represent potentially sweeping changes to both over-the-counter and prescription acetaminophen-containing products. This article reviews the committee process, previous FDA actions on acetaminophen, and implications of the recommendations made for the orthopedic practitioner.