OTC Labeling Initiatives Impact Cough and Cold Medication Use

Since 2007, the pharmaceutical industry, several professional societies, and the FDA have collaborated on initiatives designed to limit the use of OTC cough and cold medications (CCMs) in young children. The reasoning behind the labeling changes was the misuse of CCMs leading to more frequent visits to the emergency department (ED).

Researchers from several leading medical schools in the United States published an analysis of the initiative’s impact in the November 2014 issue of The Journal of Pediatrics. Using data from the National Hospital Ambulatory Medical Care Survey and National Ambulatory Medical Care Survey, they compared visits to EDs or ambulatory clinics in 2005-2006 and 2009-2010 for children aged younger than 12 years with cough or cold-related symptoms.

Over that 5-year period, the researchers discovered that overall CCM use in EDs declined across all stratified age groups. Although the authors found no general change in the use of OTC CCMs in EDs, clinicians were significantly less likely to employ prescription CCMs, which declined from 6.7% to 2.9%.

In ambulatory clinics, however, OTC CCM use increased from 6.3% to 11.1% in most age groups, although OTC CCM use in children aged <2 years remained unchanged. Prescription CCM use declined, but the decreases were only significant in patients aged <2 years.

Although an FDA Joint Advisory Panel and the American Academy of Pediatrics have recommended against using OTC CCMs in children aged 2 to 6 years, use of the medications actually increased significantly in children treated in ambulatory clinics in this age group.

Despite their findings of little change in the use of OTC CCMs in children aged younger than 2 years, the authors stated that the implementation of labeling recommendations and warnings for the medications have had a positive impact, as pediatric poisonings and ED visits for CCM-related adverse effects have decreased significantly.