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Pediatric Fatalities Associated With Over-the-Counter Cough and Cold Medications.

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Over-the-counter cough and cold medications (CCMs) were linked to pediatric fatalities, primarily in young children, due to non-therapeutic use. These deaths often involved deliberate administration by caregivers with intent to harm or sedate.

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Area of Science:

  • Pediatric Safety
  • Pharmacovigilance
  • Toxicology

Background:

  • Over-the-counter cough and cold medications (CCMs) underwent labeling changes in 2008 due to safety concerns in children.
  • Fatalities in children exposed to CCMs prompted further safety surveillance.

Purpose of the Study:

  • To describe fatalities associated with CCM exposure in children under 12 years old.
  • To analyze data from a safety surveillance system between 2008 and 2016.

Main Methods:

  • Utilized the Pediatric Cough and Cold Safety Surveillance System to identify fatalities.
  • Expert panel reviewed cases for causal relationship, intent, and dosage.
  • Root cause analysis identified contributing factors.

Main Results:

  • 40 of 180 eligible fatalities were related to CCMs.
  • Majority occurred in children under 2 years old (60%) with non-therapeutic intent (55%).
  • Diphenhydramine was the most common ingredient; 15% of deaths involved murder and 17.5% involved intentional sedation.

Conclusions:

  • Pediatric fatalities linked to CCMs predominantly occurred in young children.
  • Deliberate medication administration with non-therapeutic intent by caregivers was a key factor.