OTC Analgesic Toxicity Review Expected By Fall – FDA
This article was originally published in The Tan Sheet
Executive Summary
FDA plans to review the potential toxicity risks of all OTC analgesics at an upcoming advisory committee meeting, the agency said
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FDA plans to review the potential toxicity risks of all OTC analgesics at an upcoming advisory committee meeting, the agency said. The meeting, expected to be held in either June or September, will focus on the toxicological risks of the analgesic ingredients acetaminophen, ibuprofen, naproxen sodium, ketoprofen and aspirin in the context of consumer decision-making in an OTC setting. FDA's Nonprescription Drugs Advisory Committee is slated to meet June 21; a final agenda topic has not been announced. By deciding to discuss OTC analgesics across the board, FDA has opted not to single out acetaminophen. According to the agency, acetaminophen's potential liver toxicity was to be the topic of an April 22 joint meeting between NDAC and the new Drug Safety & Risk Management Subcommittee (1 (Also see "Acetaminophen Toxicity Headed To NDAC, New FDA Drug Safety Group" - Pink Sheet, 18 Feb, 2002.), p. 3). However, discussion was postponed to broaden the dialogue to other ingredients. NDAC instead will review three NDAs submitted by Schering-Plough to switch its antihistamine Claritin during the April 22 session (see 2 (Also see "OTC Claritin Hatch/Waxman Exclusivity Not Expected By Schering-Plough" - Pink Sheet, 11 Mar, 2002.)). While the analgesics discussion still may center on hepatotoxicity, it also likely will cover other potential risks, such as stomach bleeding, related to the use of OTC pain relievers and/or fever reducers. Interest in the issue has been driven by officials in FDA's Office of Drug Safety, and as such, the topic of safety is sure to take center stage. However, the adequacy of product labeling could be revisited as well. Under FDA's final rule published in October 1998, OTC adult analgesics/antipyretics are required to carry organ-specific statements cautioning against the use of such products when consuming three or more alcoholic drinks per day (3 (Also see "Analgesics Alcohol Warning Required By April 23 In Final Rule" - Pink Sheet, 26 Oct, 1998.), p. 3). Although the reg culminated nearly 10 years of debate over analgesic labeling, renewed FDA concern over consumer risk and misuse, particularly of acetaminophen, has gained momentum. |