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 Withdrawaland 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.