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Safety Profile of Cough and Cold Medication Use in Pediatrics

Jody L Green1, George Sam Wang2, Kate M Reynolds3

  • 1Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado; jody.green@rmpdc.org.

Pediatrics
|June 1, 2017
PubMed

Insights

Cough and cold medication (CCM) use in children under 12 showed a low adverse event rate. Fatalities were rare, particularly at therapeutic doses, with accidental ingestions being most common.

Area of Science:

  • Pediatric Pharmacology
  • Public Health Surveillance
  • Medication Safety

Background:

  • Concerns exist regarding the safety of cough and cold medications (CCMs) in pediatric populations.
  • Multisystem surveillance is crucial for evaluating medication safety in children.

Purpose of the Study:

  • To characterize the safety profile of CCMs in children under 12 years of age.
  • To identify common adverse events and exposure types associated with CCMs in this age group.

Main Methods:

  • Analysis of adverse event (AE) cases from 5 data sources involving CCM ingredients in children <12 years.
  • Expert panel review to determine AE relatedness, dose, intent, and risk factors.
  • Descriptive analysis of case characteristics and reported AEs.

Main Results:

  • Over 77% of 4202 reviewed cases were potentially related to CCMs, with accidental unsupervised ingestions (67.1%) being most frequent.
  • Common AEs included tachycardia, somnolence, hallucinations, ataxia, mydriasis, and agitation.
  • A low overall AE rate of 0.573 per million units sold was reported; 20 deaths (0.6%) occurred, primarily in children under 2, none at therapeutic doses.

Conclusions:

  • CCMs demonstrate a low rate of adverse events in children under 12.
  • Fatalities are infrequent and did not involve therapeutic doses.
  • Targeted prevention efforts are recommended, focusing on accidental unsupervised ingestions and pediatric liquid formulations.
Abstract

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