Acetaminophen allergenicity
This article was originally published in The Tan Sheet
Executive Summary
Whitehall-Robins submits data to FDA regarding acetaminophen's allergenic potential in support of the firm's request the analgesic ingredient be required to bear warnings. The Advil maker provides FDA with eight reports published from 1996-1998 on "consumers' acute hypersensitivity reactions, anaphylaxis, urticaria/ angioedema, delayed hypersensitivity and hypotension following exposure to acetaminophen." The firm notes, "These and previously submitted data indicate that acetaminophen can produce significant and clinically relevant allergic reactions in both aspirin sensitive and insensitive consumers." Whitehall previously filed submissions with FDA in 1989, 1993 and 1997 supporting its request. Advil (ibuprofen) bears a warning on the risk of adverse reactions in aspirin-sensitive patients