Acetaminophen products do not need aspirin cross-reactivity warning, McNeil argues.
This article was originally published in The Tan Sheet
Executive Summary
ASPIRIN-SENSITIVE WARNING ON ACETAMINOPHEN UNJUSTIFIED, McNEIL ARGUES in a May 15 response to a Whitehall-Robins Health- care submission to FDA proposing an aspirin cross-reactivity label warning be required on acetaminophen products. The marketer of Tylenol acetaminophen argues that after a review of the scientific data and evidence from the product's four-decade marketing history, "there is no substantial or credible scientific evidence that cross-reactivity between aspirin and acetaminophen occurs at any clinically important level." The firm concludes "there is no justification for an aspirin-sensitive cross-reactivity warning on acetaminophen products."