The safety of cough and cold medication (CCM) use in children has always been probed. This study will describe the safety profile of CCMs in children below the age of 12 years from a multisystem surveillance program.

Cases having adverse events (AEs) after ingestion of minimum 1 index CCM ingredient (brompheniramine, dextromethorphan, chlorpheniramine, diphenhydramine, guaifenesin, phenylephrine, doxylamine and pseudoephedrine) in children <12 years of age were collected from five data sources. An expert panel then assessed the relatedness, intent, dose and risk factors.

Out of the 4202 cases studied, 3251 cases (77.4%) were determined to be minimum potentially related to a CCM, with accidental ingestions (67.1%) that were not supervised and medication errors (13.0%) were the most common exposure types. Liquid (67.3%), single-ingredient (77.5%) formulations and paediatric (75.5%) were commonly involved. AEs occurred in >20% of all the cases that included tachycardia, hallucinations, somnolence, mydriasis, ataxia and agitation. Twenty cases i.e., 0.6% resulted in death and the children <2 years of age (70.0%) and none of them involved a therapeutic dose. The overall documented AE rate was 0.573 cases per 1 million units (i.e., tablets, gelatin capsules, or liquid) sold or 1 case per 1.75 million units.

The study concluded that the rate of AEs associated with CCMs in children was very low and mortalities also occurred less frequently. No fatality had involved a therapeutic dose. Accidental not supervised ingestions were the common exposure types and single-ingredient. Paediatric liquid formulations were also the most commonly documented products.

Source: Green JL, Wang GS, Reynolds KM, et al. Safety Profile of Cough and Cold Medication Use in Pediatrics. Pediatrics. 2017 Jun;139(6):e20163070. doi: 10.1542/peds.2016-3070. Epub 2017 May 4. PMID: 28562262.