J. Med. Toxicol. (2017) 13:303–308 DOI 10.1007/s13181-017-0622-8 ORIGINAL ARTICLE Evaluation of a Food and Drug Administration Mandate to Limit Acetaminophen in Prescription Combination Products 1 1 David Goldberger & David Vearrier Received: 5 January 2017 /Revised: 5 June 2017 /Accepted: 10 June 2017 /Published online: 14 July 2017 American College of Medical Toxicology 2017 Abstract 2013 with more cases being categorized as Bmajor effect^ Introduction In 2014, the US Food and Drug Administration and fewer cases being categorized as Bno effect.^ limited the production of prescription acetaminophen-opioid Conclusions The Food and Drug Administration limitation on combination products to 325 mg per dose unit. The goal of acetaminophen content per dose unit in opioid combination this mandate was to decrease the likelihood of unintentional products did not reduce the occurrence of unintentional acetaminophen hepatotoxicity. This study was designed to acetaminophen-induced hepatotoxicity or N-acetylcysteine determine if this federal regulation has succeeded in reducing administration as reported to NPDS. unintentional acetaminophen-induced hepatotoxicity from . . opioid combination products. Keywords Acetaminophen Hepatotoxicity Food and Drug Methods Using data from the National Poison Data System Administration Drug dosing limits (NPDS), we analyzed all calls to US Poison Control Centers in the years 2013 and
Journal of Medical Toxicology – Springer Journals
Published: Jul 14, 2017
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