Jody L Green1, George Sam Wang2, Kate M Reynolds3, William Banner4, G Randall Bond5, Ralph E Kauffman6, Robert B Palmer3, Ian M Paul7,8, Richard C Dart3. 1. Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado; jody.green@rmpdc.org. 2. Department of Pediatrics, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, Colorado. 3. Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado. 4. Oklahoma Center for Poison and Drug Information, Oklahoma University College of Pharmacy, Oklahoma City, Oklahoma. 5. Faculty of Medicine, Hope Africa University, Bujumbura, Burundi. 6. Department of Pediatrics, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri; and. 7. Departments of Pediatrics and. 8. Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
Abstract
BACKGROUND AND OBJECTIVES: The safety of cough and cold medication (CCM) use in children has been questioned. We describe the safety profile of CCMs in children <12 years of age from a multisystem surveillance program. METHODS: Cases with adverse events (AEs) after ingestion of at least 1 index CCM ingredient (brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine, and pseudoephedrine) in children <12 years of age were collected from 5 data sources. An expert panel determined relatedness, dose, intent, and risk factors. Case characteristics and AEs are described. RESULTS: Of the 4202 cases reviewed, 3251 (77.4%) were determined to be at least potentially related to a CCM, with accidental unsupervised ingestions (67.1%) and medication errors (13.0%) the most common exposure types. Liquid (67.3%), pediatric (75.5%), and single-ingredient (77.5%) formulations were most commonly involved. AEs occurring in >20% of all cases included tachycardia, somnolence, hallucinations, ataxia, mydriasis, and agitation. Twenty cases (0.6%) resulted in death; most were in children <2 years of age (70.0%) and none involved a therapeutic dose. The overall reported AE rate was 0.573 cases per 1 million units (ie, tablets, gelatin capsules, or liquid equivalent) sold (95% confidence interval, 0.553-0.593) or 1 case per 1.75 million units. CONCLUSIONS: The rate of AEs associated with CCMs in children was low. Fatalities occurred even less frequently. No fatality involved a therapeutic dose. Accidental unsupervised ingestions were the most common exposure types and single-ingredient, pediatric liquid formulations were the most commonly reported products. These characteristics present an opportunity for targeted prevention efforts.
BACKGROUND AND OBJECTIVES: The safety of cough and cold medication (CCM) use in children has been questioned. We describe the safety profile of CCMs in children <12 years of age from a multisystem surveillance program. METHODS: Cases with adverse events (AEs) after ingestion of at least 1 index CCM ingredient (brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine, and pseudoephedrine) in children <12 years of age were collected from 5 data sources. An expert panel determined relatedness, dose, intent, and risk factors. Case characteristics and AEs are described. RESULTS: Of the 4202 cases reviewed, 3251 (77.4%) were determined to be at least potentially related to a CCM, with accidental unsupervised ingestions (67.1%) and medication errors (13.0%) the most common exposure types. Liquid (67.3%), pediatric (75.5%), and single-ingredient (77.5%) formulations were most commonly involved. AEs occurring in >20% of all cases included tachycardia, somnolence, hallucinations, ataxia, mydriasis, and agitation. Twenty cases (0.6%) resulted in death; most were in children <2 years of age (70.0%) and none involved a therapeutic dose. The overall reported AE rate was 0.573 cases per 1 million units (ie, tablets, gelatin capsules, or liquid equivalent) sold (95% confidence interval, 0.553-0.593) or 1 case per 1.75 million units. CONCLUSIONS: The rate of AEs associated with CCMs in children was low. Fatalities occurred even less frequently. No fatality involved a therapeutic dose. Accidental unsupervised ingestions were the most common exposure types and single-ingredient, pediatric liquid formulations were the most commonly reported products. These characteristics present an opportunity for targeted prevention efforts.
Authors: Faris Alghamdi; Catherine Roth; Kris R Jatana; Charles A Elmaraghy; Julie Rice; Joseph D Tobias; Arlyne K Thung Journal: J Pain Res Date: 2020-11-19 Impact factor: 3.133
Authors: Jody L Green; Kate M Reynolds; William Banner; G Randall Bond; Ralph E Kauffman; Robert B Palmer; Ian M Paul; Richard C Dart Journal: BMC Med Res Methodol Date: 2018-12-22 Impact factor: 4.615
Authors: Rachel S Meyers; Jennifer Thackray; Kelly L Matson; Christopher McPherson; Lisa Lubsch; Robert C Hellinga; David S Hoff Journal: J Pediatr Pharmacol Ther Date: 2020
Authors: Samuel H F Lam; James Homme; Jahn Avarello; Alan Heins; Denis Pauze; Sharon Mace; Ann Dietrich; Michael Stoner; Corrie E Chumpitazi; Mohsen Saidinejad Journal: J Am Coll Emerg Physicians Open Date: 2021-06-18