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Created
July 20, 2022 18:22
by
Researcher Metadata Database
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Added
2021_Cough_Cold_Medication_Fatalities_Pediatrics.pdf
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator Laurie Seidel Halmo
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator George Sam Wang
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator Kate M. Reynolds
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator Heather Delva-Clark
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator Malin Rapp-Olsson
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator William Banner
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator G. Randall Bond
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator Ralph E. Kauffman
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator Robert B. Palmer
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator Ian M. Paul
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator Jody L. Green
July 20, 2022 18:22
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Researcher Metadata Database
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Added Creator Richard C. Dart
July 20, 2022 18:22
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Researcher Metadata Database
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Published
July 20, 2022 18:22
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Researcher Metadata Database
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December 04, 2023 15:26
by
avs5190
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 <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 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 <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 <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.
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December 04, 2023 15:27
by
avs5190
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 <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.
- 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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Updated
April 04, 2024 10:21
by
[unknown user]