Fewer Infants, Toddlers Harmed by Cough and Cold Medications Since Withdrawal of Infant Products and Label Changes

Fewer Infants, Toddlers Harmed by Cough and Cold Medications Since Withdrawal of Infant Products and Label Changes 

By The American Academy of Pediatrics

In October 2007, manufacturers voluntarily withdrew over-the-counter infant cough and cold medications from the U.S. market. A year later, manufacturers announced labels would be revised to warn against use by children under age 4. A study in the December 2013 Pediatrics tracks whether emergency visits for young children for drug ingestions changed as a result. The study, “Cough and Cold Medication Adverse Events After Market Withdrawal and Labeling Revision,” published online Nov. 11, found that among children under age 2 and between ages 2 and 3 years, emergency department visits for cough and cold medication adverse drug events declined nationally. Before the withdrawal of the infant cough and cold medications, children under age 2 accounted for 4.1 percent of all emergency visits for adverse drug events. After the market withdrawal, they represented 2.4 percent of such visits. Among children ages 2 to 3, emergency visits for adverse drug events decreased from 9.5 percent of all adverse drug visits, to 6.5 percent following the label change.  During this time, unsupervised ingestions caused the most adverse drug events by young children. According to the study authors, reducing adverse drug events further will require preventing unsupervised ingestions, perhaps through improved packaging and promotion of safe storage practices.

The American Academy of Pediatrics is an organization of 60,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults. For more information, visit www.aap.org.