Most Acetaminophen Pediatric AERs Due To Medication Errors, FDA Asserts
This article was originally published in The Tan Sheet
Executive Summary
Exceeding the recommended daily dose of acetaminophen resulted in hepatotoxic adverse events more often than use at or below recommended amounts, FDA says in 1briefing documents for the Nonprescription Drugs Advisory Committee meeting on analgesic safety Sept. 19-20
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A pending proposed rule on pediatric acetaminophen dosing reflects concerns voiced by FDA's Nonprescription Drugs Advisory Committee about the need for standardizing pediatric formula concentrations, Division of OTC Drug Products Director Charles Ganley, MD, told the committee Sept. 19
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