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Adverse events from cough and cold medications rare among children
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Adverse events linked to cold and cough medications were infrequent among children, with most serious adverse events and fatalities occurring when single-ingredient, pediatric liquid formulations were taken accidentally while unsupervised, according to research published in Pediatrics.
“Although caregivers and physicians continue to use and recommend cold and cough medications, and adverse events requiring ED visits and hospitalizations continue, there has been some decrease in the volume of reports,” Jody L. Green, PhD, from the Rocky Mountain Poison and Drug Center at the Denver Health and Hospital Authority, and colleagues wrote. “Continued use is also demonstrated by the fact that U.S. consumers spend over $5 billion annually on these products.”
For researchers to depict the safety of cold and cough medications for children younger than 12 years old, they collected data from five sources, which included information on adverse events after ingestion of one or more index ingredients, such as brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine and pseudoephedrine.
A panel of experts examined these data for relatedness, dose, intent and risk factors, and explained case characteristics and adverse events.
Experts analyzed 4,202 cases, 77.4% (n = 3,251) of which had been at least potentially related to the ingestion of cold and cough medication. Regarding exposure types, the most frequently attributed categories included accidental unsupervised doses (67.1%) and medication errors (13.0%).
Liquid (67.3%), pediatric (75.5%) and single-ingredient (77.5%) cold and cough medications were used in the majority of these cases, which resulted adverse events, including tachycardia, somnolence, hallucinations, ataxia, mydriasis and agitation in more than 20% of all cases. Fatalities occurred in 20 cases (0.6%) and were mainly found in children younger than 2 years (70.0%). No fatalities examined included therapeutic dosing of cold and cough medications.
When compared with all consumption of cold and cough medications, adverse events were noted in one in every 1.75 million units sold (tablets, gelatin capsules or liquid equivalent).
Green and colleagues’ results “suggest that the availability of medication in the home and storage practices that make the medication accessible to toddlers most often lead to adverse events rather than therapeutic use per se.”
“This risk is not unique to cold and cough medications because children under 4 years of age are at high risk for any type of ingestion due to the exploratory nature of children this age and given that any high volume and/or dose ingested may lead to an adverse event due to their small size,” the researchers wrote. — by Katherine Bortz
Disclosure: This research was funded by the Consumer Healthcare Products Association.
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