Petition Asks For Cognitive Impairment Warning On H1 Antihistamines
This article was originally published in The Tan Sheet
Executive Summary
CHPA says existing label warnings about “marked drowsiness” sufficiently cover the risk of confusion when using the products. A petition requesting label warnings about cognitive impairment for OTCs with first-generation antihistamines or anticholinergic ingredients “raises complex issues requiring extensive review and analysis,” FDA says.