The safety of cough and cold medication (CCM) use in children has been questioned.

The purpose of a study published in Pediatrics was to describe the safety profile of CCMs in children < 12 years of age, from a multisystem surveillance program.

In this study, cases with adverse events (AEs) after ingestion of at least one index CCM ingredient – brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine and pseudoephedrine, in children < 12 years of age, were collected from five data sources. An expert panel determined relatedness, dose, intent and risk factors. Case characteristics and AEs were described.

Out of the 4 202 cases reviewed, 3 251 (77.4%) were determined to be at least potentially related to a CCM, with accidental unsupervised ingestions (67.1%) and medication errors (13.0%) the most common exposure types. Liquid (67.3%), pediatric (75.5%) and single-ingredient (77.5%) formulations were most commonly involved. AEs occurring in > 20% of all cases included tachycardia, somnolence, hallucinations, ataxia, mydriasis and agitation. Twenty cases (0.6%) resulted in death—most were in children < 2 years of age (70.0%) and none involved a therapeutic dose. Moreover, the overall reported AE rate was 0.573 cases per 1 million units (that is, tablets, gelatin capsules or liquid equivalent) sold or one case per 1.75 million units.

It was concluded that the rate of AEs associated with CCMs in children was low. Fatalities occurred even less frequently. No fatality involved a therapeutic dose. Accidental unsupervised ingestions were the most common exposure types and single-ingredient, pediatric liquid formulations were the most commonly reported products. 

Source: Pediatrics. 2017 Jun;139(6):e20163070. doi: 10.1542/peds.2016-3070. Epub 2017 May 4.