Changes in OTC cough and cold medication labels recommending against their use in children younger than 4 years have led to a significant decrease in unintentional ingestions by children.

Changes to labels of over-the-counter cough and cold medications urging that they not be used in young children have led to a decrease in the number of children inappropriately exposed to the medications, according to the results of a study published online on June 14, 2013, in the Journal of Pediatrics.
Based on the potential risks of OTC cough and cold medication use in young children and concerns expressed by the FDA, the Consumer Healthcare Products Association (CHPA), a pharmaceutical industry group, voluntarily withdrew these products marketed for use in children younger than 2 years in October 2007. A year later, the CHPA issued warnings against the use of these medications in children younger than 4 years. The FDA is currently reviewing data and considering whether to change the labeling of OTC cough and cold medications for children up to the age of 6 years.

To gauge the effects of the voluntary labeling changes, the researchers conducted a retrospective database study evaluating their impact on pediatric ingestions of OTC cough and cold medications reported to poison centers. Data on ingestions reported to all US poison centers from 2000 to 2010 were collected from the National Poison Data System. All therapeutic errors and unintentional exposures to OTC antihistamines, decongestants, expectorants, or cough suppressants in children younger than 13 years were included in the study. Therapeutic errors included administering an incorrect dose, administering the medication to the wrong person, or administering the wrong medication. OTC status was determined from specific product codes, and prescription-only medications were excluded from the study.
Children were studied in 3 age groups: children younger than 2 years, children aged 2 to 5 years, and children aged 6 to 12 years. The 6-to-12 age group served as a control group, since the label changes did not directly affect them. To compare the exposure rates immediately before and after label changes were implemented, the data were further divided into a pre-intervention period (2005 to 2006) and a post-intervention period (2009 to 2010).
The researchers analyzed the month and year of ingestion, age of the patient, product ingested, and whether the ingestion was due to therapeutic error or to unintentional exposure. They also studied whether children were treated at a health care facility or at home, and whether the exposure led to minor or major adverse effects.
Significant decreases in both therapeutic errors and unintentional ingestions between the pre- and post-intervention periods were observed. Across all age groups, unintentional ingestions declined by 33.4%, and therapeutic errors declined by 46.0%. The largest declines were seen in children younger than 2 years, among whom referrals to a health care facility due to therapeutic error decreased by 59.2% and referrals due to unintentional ingestions decreased by 28.9%. Referrals to a health care facility due to unintentional ingestion also decreased by almost 20% in children aged 2 to 5 years.
The study authors attribute these dramatic decreases to limited access to OTC cough and cold medications marketed for children younger than 2 years, updated warning labels, and increased parental awareness of the medications’ potential danger to young children. To further reduce ingestion rates, the authors suggest that OTC cough and cold medication label warnings should be expanded to include all children younger than 6 years. They also encourage health care providers to counsel parents on proper medication use and storage.

Do you think OTC cough and cold medication labels should be changed to recommend against use by children up to 6 years of age? Vote in our poll.