GI bleeding risk in ibuprofen users not increased by alcohol use, Whitehall maintains.
This article was originally published in The Tan Sheet
Executive Summary
IBUPROFEN GI BLEEDING RISK NOT INCREASED BY ALCOHOL, WHITEHALL ASSERTS in an Oct. 23 letter to FDA on whether OTC ibuprofen products should bear an alcohol use warning. Whitehall-Robins, the maker of Advil, has long opposed alcohol warnings on ibuprofen-containing OTCs. Responding to an Oct. 2 letter to FDA by McNeil Consumer Products, Whitehall disputes conclusions the Tylenol (acetaminophen) marketer draws from a study by Boston University School of Medicine's Slone Epidemiology Unit on analgesics, alcohol and upper gastrointestinal bleeding. "Contrary to the assertions in McNeil's Oct. 2 letter to the docket, significant clinical and epidemiologic data show that OTC ibuprofen has excellent GI tolerability," the Advil marketer asserts.