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More efforts needed to curb OTC cough, cold medicine use in young children

Legislation mandating labels warning against the use of OTC cough and cold medicine among children younger than 6 years has resulted in only a modest decrease in parents turning to such treatments, and stronger measures may be required to further curb its practice, according to data published in the Canadian Journal of Public Health.

“[Cough and cold medications] are the leading cause of emergency department visits from adverse drug reactions, including allergic and neurologic complications,” Julie Degroot, MSc, from Saint Michael’s Hospital, at the University of Toronto, and colleagues wrote. “… In 2008, pharmaceutical manufacturers in the U.S. voluntarily relabeled OTC [cough and cold medications] to state that products should not be used in children younger than 4 years of age. In October 2009, Health Canada required manufacturers to relabel OTC [cough and cold medications] containing antihistamines, antitussives, expectorants and decongestants to indicate that the product should not be used for children younger than 6 years of age; the prohibition ‘Do not use this cough and cold product in children under 6 years of age’ must be included on the inner and outer labels of all products.”

To find whether the Canadian labeling requirements resulted in a decrease in OTC cough and cold medication use among young children who recently had a cough, cold or influenza, the researchers conducted an interrupted time series study. They used data from the “TARGet Kids!” practice-based research network in Toronto, and recruited 3,515 healthy children aged 1 to 5 years from 2008 to 2011. Of the recruited children, 1,072 had a cough, cold or influenza within the previous month and were chosen to participate in the study.

Parents answered standardized questionnaires, and the researchers compared the reported use of OTC cough and cold medications before and after the Oct. 1, 2009, change in Canadian labeling requirements, using time series analyses. In addition, they used a multivariate logistic regression to identify predictors of recent OTC cough and cold medication use.

According to the researchers, of the 1,072 children who had a cough, cold or influenza within the previous month, 20.7% had received OTC cough and cold medications for treatment. Overall, the rate of OTC cough and cold medication use among children younger than 6 years of age declined from 20.2% to 17.8% following the labeling change (P = .014). A maternal age of less than 35 years (OR = 1.49; 95% CI: 1.05-2.13) and having older siblings (OR = 1.65; 95% CI: 1.16-2.35) were independently associated with OTC cough and cold medication use.

“We have identified that a government mandated labeling standard had a small effect on curtailing OTC [cough and cold medication] use in children younger than 6 years of age,” Degroot and colleagues wrote. “Strong measures may be needed to curtail their use, such as more pronounced warning labels and keeping such products behind the pharmacy counter, to avoid inadvertent purchasing by parents of young children.”

Disclosure: Researcher Muhammad Mamdani, PharmD, MPH, reports being a consultant to Astra Zeneca, Bristol-Meyers Squibb, Glaxo Smith Kline, Hoffman LaRoche, Novartis and Pfizer. The other researchers report no relevant financial disclosures.