Latebreakers: No cough, cold OTCs for kids two to under six

November 5, 2007

FDA advisory panel says OTC cough and cold meds should not be used by children under six.

Following a recent two-day meeting, an FDA advisory panel voted 13 to 9 to recommend that OTC cough and cold products should not be used in children two years to less than six years and said there is no evidence that these products work in children. Following the meeting, Linda Suydam, president of the Consumer Healthcare Products Association (CHPA), stated that "the split vote to make singleactive ingredients no longer available for use in children under six years old-if adopted by FDA-would unduly limit parents' access to medicines that work and are safe when taken as directed.... We are already planning pharmacokinetic studies in children, which are the first step toward confirming correct dosing, and we will work with the FDA to design appropriate pediatric clinical efficacy studies."