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

Abstract

BACKGROUND AND OBJECTIVES: In 2008, over-the-counter cough and cold medications (CCMs) underwent labeling changes in response to safety concerns, including fatalities, reported in children exposed to CCMs. The objective of this study is to describe fatalities associated with exposures to CCMs in children <12 years old that were detected by a safety surveillance system from 2008 to 2016.METHODS: Fatalities in children <12 years old that occurred between 2008 and 2016 associated with oral exposure to one or more CCMs were identified by the Pediatric Cough and Cold Safety Surveillance System. An expert panel reviewed all cases to determine the causal relationship between the exposure and death, if the intent of exposure was therapeutic, and if the dose was supratherapeutic. Other contributing factors related to the child's death were also identified as part of a root cause analysis.RESULTS: Of the 180 eligible fatalities captured during the study period, 40 were judged by the expert panel to be either related or potentially related to the CCM. Of these, the majority (n 5 24; 60.0%) occurred in children <2 years old and involved nontherapeutic intent (n 5 22; 55.0%). The most frequently involved index ingredient was diphenhydramine (n 5 28; 70.0%). In 6 cases (n 5 6; 15.0%), the CCM was administered to murder the child. In another 7 cases (n 5 7; 17.5%), death followed the intentional use of the CCM to sedate the child.CONCLUSIONS: Pediatric fatalities associated with CCMs occurred primarily in young children after deliberate medication administration with nontherapeutic intent by a caregiver.

Comparing the Effectiveness of Honey Consumption With Anti-Cough Medication in Pediatric Patients: A Systematic Review

“…In comparison, an observational study reported 40 out of 180 fatalities related to children < 12 years old. The most prevalent cause of fatality was diphenhydramine ingestion [ 19 ]. Furthermore, CCM-related fatalities, primarily among young children, were given by a caregiver for non-medical purposes.…”

“…Furthermore, CCM-related fatalities, primarily among young children, were given by a caregiver for non-medical purposes. Seven fatal cases were associated with intentional use of sedation [ 19 ]. One study reported that from 2008 to 2016, > 40% of CCM-associated fatalities occurred in children < 12 years old [ 12 , 19 ].…”

“…Seven fatal cases were associated with intentional use of sedation [ 19 ]. One study reported that from 2008 to 2016, > 40% of CCM-associated fatalities occurred in children < 12 years old [ 12 , 19 ]. The fatalities were rare, though typically occurred in children under two years old and for non-treatment purposes [ 12 , 19 ].…”

“…One study reported that from 2008 to 2016, > 40% of CCM-associated fatalities occurred in children < 12 years old [ 12 , 19 ]. The fatalities were rare, though typically occurred in children under two years old and for non-treatment purposes [ 12 , 19 ]. The most prevalent cause of fatalities involved diphenhydramine, an antihistamine [ 12 , 19 ].…”

“…The fatalities were rare, though typically occurred in children under two years old and for non-treatment purposes [ 12 , 19 ]. The most prevalent cause of fatalities involved diphenhydramine, an antihistamine [ 12 , 19 ]. ‎In 2019, Poison Control Centers reported an increase in fatality rates by 16.3% in children < 20 days-old [ 30 ].…”