Pediatric fatalities associated with over-the-counter cough and cold medications

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 = 24; 60.0%) occurred in children <2 years old and involved nontherapeutic intent (n = 22; 55.0%). The most frequently involved index ingredient was diphenhydramine (n = 28; 70.0%). In 6 cases (n = 6; 15.0%), the CCM was administered to murder the child. In another 7 cases (n = 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.

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Work Title Pediatric fatalities associated with over-the-counter cough and cold medications
Access
Open Access
Creators
  1. Laurie Seidel Halmo
  2. George Sam Wang
  3. Kate M. Reynolds
  4. Heather Delva-Clark
  5. Malin Rapp-Olsson
  6. William Banner
  7. G. Randall Bond
  8. Ralph E. Kauffman
  9. Robert B. Palmer
  10. Ian M. Paul
  11. Jody L. Green
  12. Richard C. Dart
Keyword
  1. Cold medication
  2. Cough
  3. Death of child
  4. Drugs
  5. Non-prescription
  6. Diphenhydramine
License In Copyright (Rights Reserved)
Work Type Article
Publisher
  1. Pediatrics
Publication Date November 1, 2021
Publisher Identifier (DOI)
  1. https://doi.org/10.1542/peds.2020-049536
Deposited July 20, 2022

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Version 1
published

  • Created
  • Added 2021_Cough_Cold_Medication_Fatalities_Pediatrics.pdf
  • Added Creator Laurie Seidel Halmo
  • Added Creator George Sam Wang
  • Added Creator Kate M. Reynolds
  • Added Creator Heather Delva-Clark
  • Added Creator Malin Rapp-Olsson
  • Added Creator William Banner
  • Added Creator G. Randall Bond
  • Added Creator Ralph E. Kauffman
  • Added Creator Robert B. Palmer
  • Added Creator Ian M. Paul
  • Added Creator Jody L. Green
  • Added Creator Richard C. Dart
  • Published
  • Updated Keyword, Description Show Changes
    Keyword
    • Cold medication, Cough, Death of child, Drugs, Non-prescription, Diphenhydramine
    Description
    • <p>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 &lt;12 years old that were detected by a safety surveillance system from 2008 to 2016. METHODS: Fatalities in children &lt;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 deathwere 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 &lt;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.</p>
    • 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 &lt;12 years old that were detected by a safety surveillance system from 2008 to 2016.
    • METHODS: Fatalities in children &lt;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 &lt;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.
  • Updated Description Show Changes
    Description
    • 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 &lt;12 years old that were detected by a safety surveillance system from 2008 to 2016.
    • METHODS: Fatalities in children &lt;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 &lt;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.
    • 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 = 24; 60.0%) occurred in children &lt;2 years old and involved nontherapeutic intent (n = 22; 55.0%). The most frequently involved index ingredient was diphenhydramine (n = 28; 70.0%). In 6 cases (n = 6; 15.0%), the CCM was administered to murder the child. In another 7 cases (n = 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.