Changing winds: practice implications of acetaminophen regulations.
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.
Rogalski
Andrew L
AL
University of Kentucky Healthcare, Lexington, Kentucky 40536, USA.
Smith
Kelly M
KM
D000082:Acetaminophen / Q000009:adverse effects*; D026683:Advisory Committees; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury / Q000517:prevention & control*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D006287:Health Planning Guidelines; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen