Safety Profile of Cough and Cold Medication Use in Pediatrics

被引：28

作者：

Green, Jody L. ^{[1
]}

Wang, George Sam ^{[2
]}

Reynolds, Kate M. ^{[1
]}

Banner, William ^{[3
]}

Bond, G. Randall ^{[4
]}

Kauffman, Ralph E. ^{[5
]}

Palmer, Robert B. ^{[1
]}

Paul, Ian M. ^{[6
,7
]}

Dart, Richard C. ^{[1
]}

机构：

[1] Denver Hlth & Hosp Author, Rocky Mt Poison & Drug Ctr, Denver, CO USA

[2] Univ Colorado Anschutz Med Campus, Childrens Hosp Colorado, Dept Pediat, Aurora, CO USA

[3] Univ Oklahoma, Coll Pharm, Oklahoma Ctr Poison & Drug Informat, Oklahoma City, OK USA

[4] Hope Africa Univ, Fac Med, Bujumbura, Burundi

[5] Univ Missouri, Sch Med, Dept Pediat, Kansas City, MO 64108 USA

[6] Penn State Coll Med, Dept Pediat, Hershey, PA USA

[7] Penn State Coll Med, Dept Publ Hlth Sci, Hershey, PA USA

来源：

PEDIATRICS | 2017年 / 139卷 / 06期

关键词：

YOUNG-CHILDREN; POISON CENTERS; WITHDRAWAL; INGESTIONS;

D O I：

10.1542/peds.2016-3070

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

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.

引用

页数：8

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