Acetaminophen
This article was originally published in The Tan Sheet
Executive Summary
Questions of whether analgesic depletes glutathione and should carry label warning against excessive use by HIV-infected individuals "are being addressed" in FDA's evaluation of acetaminophen toxicity "in various populations, in specific clinical situations and at different dosages," agency says. In an interim response to a petition from Leonore Herzenberg, PhD, Stanford University, requesting such a warning, FDA notes its analysis "includes a review of the possible need for revised labeling." FDA is examining more extensive ways to inform consumers of acetaminophen risks and limit OTC access. Agency also is reviewing McNeil's request to expand age groups for OTC pediatric dosing instructions