FDA Recommends No Cough and Cold OTCs for Children Under Two

ePT--the Electronic Newsletter of Pharmaceutical Technology

Based on its investigation into the safety of over-the-counter cough and cold drug products for children, the US Food and Drug Administration is recommending against such products for all children under two years of age.

Rockville, MD (Jan. 17)-Based on its investigation into the safety of over-the-counter (OTC) cough and cold drug products for children, the US Food and Drug Administration is recommending against such products for all children under two years of age. In a public health advisory, the agency cited the possibility of “serious and potentially life-threatening side effects” associated with these OTCs when administered to children.

During its investigation, FDA reviewed information it had received about serious side effects and the discussion and recommendations made at an October 2007 public advisory committee meeting. In a public statement, the agency said it “supports the actions taken by many pharmaceutical manufacturers to voluntarily withdraw cough and cold medicines that were being sold for use in this age group.” Because it was a voluntary recall, not all products were removed immediately.

According to a December 2007 New England Journal of Medicine article, consumers purchase nearly 95 million packages of OTC cough and cold preparations for children every year (1). These products include various combinations of antihistamines, decongestants, antitussives, and expectorants. “There is no standard for describing these products,” the authors state. “Two products marketed similarly may have different types of ingredients.”

FDA is currently completing its investigation into the safety of cough and cold OTCs for children between 2 and 11 years of age.

1. J.M. Sharfstein, M. North, and J.R. Serwint, “Over the Counter but No Longer under the Radar-Pediatric Cough and Cold Medicines,” N. Engl. J. Med.357, 2321–2324.