Recommendations for the Use of OTC Cough and Cold Medications in Children

Ann McMahon Wicker, PharmD, BCPS; Brice A. Labruzzo, PharmD


US Pharmacist. 2009;34(3):33-36. 

In This Article

Voluntary and Regulatory Changes

The safety of OTC cough and cold preparations in the pediatric population is of great concern owing to reports of severe adverse reactions and deaths in infants and children. In October 2007, the FDA's advisory committees on Nonprescription Drugs and Pediatrics met to discuss the safety and efficacy of nonprescription cough and cold medications in children. Ten days prior to the meeting, a voluntary withdrawal of 14 nonprescription infant cough and cold medications was announced by the Consumer Healthcare Products Association (CHPA) on behalf of the products' manufacturers. Manufacturers recalled these products even though they believed that they were safe. Cases of misuse leading to overdose of infants less than 2 years of age had been reported. The advisory committees concluded that evidence from pediatric studies was insufficient to prove the efficacy of cold and cough medications in children; they voted 13 to 9 to recommend that cough and cold products no longer be used in children under 6 years of age.[13,14]

The FDA issued a public health advisory in January 2008 recommending that OTC cough and cold medications not be used in children under 2 years of age because of the risk of serious, life-threatening adverse events. Additionally, the FDA agreed to the manufacturers' request to change the product labeling to warn parents not to use antihistamine products to sedate children.[13,14]

In 2008, the FDA held two public meetings to gather more information about the regulatory process for pediatric cough and cold medicines and about scientific testing in children. On October 8, 2008, the FDA issued a statement supporting the CHPA's announcement that manufacturers of nonprescription OTC cough and cold medicines for children were voluntarily modifying package labeling to state, "Do not use in children under 4 years of age."[15]

In addition to product-labeling changes, new child-resistant packaging and measuring devices for the products are being introduced. The manufacturers have been transitioning this new labeling and packaging throughout the 2008-2009 cough and cold season.[1]