Antihistamine-containing cough/cold medications present a low hazard in pediatric accidental exposure incidents: analysis of Poison Control Center data.
We studied accidental exposure to pediatric cough/cold medications in children under 6-y-of-age to determine whether the presence of an antihistamine (chlorpheniramine) in the product increased the likelihood for adverse outcomes. General accidental exposure cases reported to the American Association of Poison Control Centers (AAPCC) during 1988-1992 were analyzed for specific over-the-counter cough/cold pediatric products containing identical concentrations of active ingredients except for the presence or absence of chlorpheniramine. These case reports were evaluated for differences in medical outcome, symptom assessment, management site and therapy, as coded by poison control centers participating in the AAPCC Toxic Exposure Surveillance System. A total of 10,289 cases of accidental exposures were evaluated for the specific products included in this analysis. While these cases represented a small percentage of total exposures to these products (approximately 3% of total cases in children under 6-y-of-age reported to the AAPCC for all cough/cold medications during 1988-1992), they provided a unique opportunity to evaluate the impact of the antihistamine component of the formulation. This study demonstrated that the presence of chlorpheniramine did not affect the medical outcome or the extent to which symptoms were reported. Additionally, similar percentages of exposures for these 2 products were managed at the site of the incident, and required either no therapy or only required fluids and observation. There were no notable differences in the percentage of cases which involved more aggressive treatment procedures (activated charcoal, cathartic, lavage). This analysis demonstrates that over-the-counter cough/cold medications containing chlorpheniramine present low potential for hazard in cases of accidental ingestions in young children and do not show an increased likelihood for adverse outcomes of accidental exposures compared to cough/cold medications not containing this antihistamine.
Skare
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JA
Regulatory and Clinical Development Division, Procter & Gamble Company, Mason, OH 45040, USA.
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D002648:Child; D002675:Child, Preschool; D002744:Chlorpheniramine / Q000009:adverse effects*; D003139:Common Cold / Q000188:drug therapy*; D003371:Cough / Q000188:drug therapy*; D006634:Histamine H1 Antagonists / Q000009:adverse effects*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn
D006634:Histamine H1 Antagonists; D002744:Chlorpheniramine