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

Author:

Halmo Laurie Seidel12,Wang George Sam12,Reynolds Kate M.2,Delva-Clark Heather23,Rapp-Olsson Malin2,Banner William4,Bond G. Randall5,Kauffman Ralph E.6,Palmer Robert B.2,Paul Ian M.7,Green Jody L.28,Dart Richard C.2

Affiliation:

1. Department of Pediatrics, Children’s Hospital Colorado and University of Colorado Anschutz Medical Campus, Aurora, Colorado;

2. Rocky Mountain Poison and Drug Safety, Denver Health and Hospital Authority, Denver, Colorado;

3. CPC Clinical Research, Aurora, Colorado;

4. Oklahoma Center for Poison and Drug Information and College of Pharmacy, The University of Oklahoma Health Sciences Center, The University of Oklahoma, Oklahoma City, Oklahoma;

5. Faculté de Médecine, Hope Africa University, Bujumbura, Burundi;

6. Department of Pediatrics, School of Medicine, University of Missouri-Kansas City, Kansas City, Missouri;

7. Departments of Pediatrics and Public Health Sciences, College of Medicine, The Pennsylvania State University, Hershey, Pennsylvania; and

8. Inflexxion, Costa Mesa, California

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 = 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.

Publisher

American Academy of Pediatrics (AAP)

Subject

Pediatrics, Perinatology and Child Health

Reference25 articles.

1. C.S. Mott Children’s Hospital . Mott poll report: parents ignore warning labels, give cough & cold meds to young kids. 2013. Available at: https://mottpoll.org/reports-surveys/parents- ignore-warning-labels-give-cough-cold- meds-young-kids. Accessed August 3, 2020

2. Shuren J . Over the counter cough and cold medications for pediatric use; notice of public hearing. 2008. Available at: https://www.federalregister.gov/documents/2008/08/25/E8-19657/over-the-counter-cough-and-cold-medications-for-pediatric-use-notice-of-public-hearing. Accessed July 29, 2019

3. Consumer Healthcare Products Association . Makers of OTC cough and cold medicines announce voluntary withdrawal of oral infant medicines. 2007. Available at: https://www.medindia.net/health-press-release/makers-of-otc-cough-and-cold-medicines-announce-voluntary-withdrawal-of-oral-infant-medicines-5208-1.htm. Accessed October 11, 2019

4. Consumer Healthcare Products Association . Statement from CHPA on the voluntary label updates to oral OTC children’s cough and cold medicines. 2008. Available at: https://www.medindia.net/health-press-release/statement-from-chpa-on-the-voluntary-label-updates-to-oral-otc-childrens-cough-and-cold-medicines-34707-1.htm. Accessed October 11, 2019

5. Pediatric fatalities associated with over the counter (nonprescription) cough and cold medications;Dart;Ann Emerg Med,2009

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