Pediatric Fatalities Associated With Over the Counter (Nonprescription) Cough and Cold Medications
Presented at the XXVIII International Congress of the European Association of Poisons Centres and Clinical Toxicologists, May 2008, Seville, Spain.
Received 7 July 2008; received in revised form 13 August 2008 and 25 August 2008; accepted 16 September 2008. published online 22 December 2008.
Study objective
The use of nonprescription cough and cold medicines is widespread, but their use has been sporadically associated with severe toxicity and death. We evaluate the role of these medications in pediatric fatalities and identified factors that contributed to the death.
Methods
Fatalities that involved a child younger than 12 years and mentioned a cough and cold ingredient were obtained from 5 sources. An independent panel of 8 experts (pediatrics, pediatric critical care, pediatric toxicology, clinical toxicology, forensic toxicology, forensic pathology) used explicit definitions to assess the causal relationship between medication ingestion and death. Contributing factors were identified.
Results
Of 189 cases included, 118 were judged possibly, likely, or definitely related to a cough and cold ingredient. Of these 118 cases, 103 involved a nonprescription drug, whereas 15 cases involved a prescription medication alone. Of 103 cases associated with nonprescription drugs, the evidence indicated that 88 involved an overdosage. A dosage could not be assessed in the remaining 15 cases. Several contributing factors were identified: age younger than 2 years, use of the medication for sedation, use in a daycare setting, use of 2 medicines with the same ingredient, failure to use a measuring device, product misidentification, and use of a nonprescription product intended for adult use. All cases that occurred in a daycare setting involved a child younger than 2 years.
Conclusion
In our sample, pediatric fatalities caused by nonprescription cough and cold medications were uncommon, involved overdose, and primarily affected children younger than 2 years. The intent of caregivers appears to be therapeutic to relieve symptoms in some cases and nontherapeutic to induce sedation or to facilitate child maltreatment in other cases.
aRocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO
bUniversity of Colorado School of Medicine, Aurora, CO
fSkaggs School of Pharmacy and Pharmaceutical Sciences, University of California–San Diego, La Jolla, CA
hUniversity of Missouri–Kansas City School of Medicine, Kansas City, MO
iOklahoma Poison Control Center, The Children's Hospital at Saint Francis, Department of Pediatrics, Oklahoma University College of Medicine, Tulsa, OK
Address for correspondence: Richard C. Dart, MD, PhD, Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, 777 Bannock Street, Mail Code 0180, Denver, CO 80204; 303-739-1119, fax 303-739-1443
Supervising editors: Michael W. Shannon, MD; Michael L. Callaham, MD
Dr. Shannon and Dr. Callaham were the supervising editors on this article. Dr. Dart did not participate in the editorial review or decision to publish this article.
Author contributions: RCD and JLG conceived the study, designed the process, and obtained research funding. RCD and JLG supervised the conduct of the trial and data collection. RCD and JLG recruited panel members and managed the data, including quality control. RCD drafted the article, and all authors group contributed substantially to its revision. RCD takes responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article, that might create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. This research was supported by an investigator-initiated grant from McNeil Consumer Healthcare to Denver Health and Hospital Authority. The panel members received a stipend from Denver Health and Hospital for their participation. The project was proposed and designed by Dr. Dart. The cases in the category of “manufacturer’s adverse events” were identified by each manufacturer individually and supplied to Denver Health. None of the researchers received consultation fees or any other compensation from the manufacturer. McNeil Consumer Products had no input into the design, definitions of causality, panel proceedings, analysis of results or drafting of the article.
Publication dates: Available online December 19, 2008.
ABSTRACT