Adverse Events from Cough and Cold Medications in Children

In October 2007, following FDA review of and concerns about the safety and effectiveness of over-the-counter (OTC) cough and cold medications in children (Journal Watch Pediatrics and Adolescent Medicine Sep 12 2007), particularly in infants, leading drug manufacturers voluntarily withdrew cough and cold medications that were labeled for use in children younger than 2 years. To characterize adverse drug events from OTC cough and cold medications in children, researchers used data from the Adverse Drug Event Surveillance project (representing 63 U.S. emergency departments [EDs]).

In 2004 and 2005, an estimated 7091 children (age, <12 years) visited EDs annually because of adverse drug events from cough and cold medications; this number repres…