PMID- 28562262
OWN - NLM
STAT- MEDLINE
DCOM- 20170907
LR  - 20170907
IS  - 1098-4275 (Electronic)
IS  - 0031-4005 (Linking)
VI  - 139
IP  - 6
DP  - 2017 Jun
TI  - Safety Profile of Cough and Cold Medication Use in Pediatrics.
LID - e20163070 [pii]
LID - 10.1542/peds.2016-3070 [doi]
AB  - 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.
CI  - Copyright (c) 2017 by the American Academy of Pediatrics.
FAU - Green, Jody L
AU  - Green JL
AD  - Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, 
      Denver, Colorado; jody.green@rmpdc.org.
FAU - Wang, George Sam
AU  - Wang GS
AD  - Department of Pediatrics, Children's Hospital Colorado, University of Colorado 
      Anschutz Medical Campus, Aurora, Colorado.
FAU - Reynolds, Kate M
AU  - Reynolds KM
AD  - Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, 
      Denver, Colorado.
FAU - Banner, William
AU  - Banner W
AD  - Oklahoma Center for Poison and Drug Information, Oklahoma University College of 
      Pharmacy, Oklahoma City, Oklahoma.
FAU - Bond, G Randall
AU  - Bond GR
AD  - Faculty of Medicine, Hope Africa University, Bujumbura, Burundi.
FAU - Kauffman, Ralph E
AU  - Kauffman RE
AD  - Department of Pediatrics, University of Missouri-Kansas City School of Medicine, 
      Kansas City, Missouri; and.
FAU - Palmer, Robert B
AU  - Palmer RB
AD  - Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, 
      Denver, Colorado.
FAU - Paul, Ian M
AU  - Paul IM
AD  - Departments of Pediatrics and.
AD  - Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
FAU - Dart, Richard C
AU  - Dart RC
AD  - Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, 
      Denver, Colorado.
LA  - eng
PT  - Journal Article
DEP - 20170504
PL  - United States
TA  - Pediatrics
JT  - Pediatrics
JID - 0376422
RN  - 0 (Antitussive Agents)
RN  - 0 (Multi-Ingredient Cold, Flu, and Allergy Medications)
SB  - IM
MH  - Antitussive Agents/*adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Cough/*drug therapy
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Female
MH  - Humans
MH  - Infant
MH  - Male
MH  - Multi-Ingredient Cold, Flu, and Allergy Medications/*adverse effects
MH  - Pediatrics
MH  - Risk Factors
MH  - Safety
COIS- POTENTIAL CONFLICT OF INTEREST: Drs Green and Dart and Ms Reynolds have received 
      grant funding from the Consumer Healthcare Products Association; Dr Paul has 
      received fees from the Consumer Healthcare Products Association; the other 
      authors have indicated they have no potential conflicts of interest to disclose.
EDAT- 2017/06/01 06:00
MHDA- 2017/09/08 06:00
CRDT- 2017/06/01 06:00
PHST- 2017/02/28 00:00 [accepted]
PHST- 2017/06/01 06:00 [pubmed]
PHST- 2017/09/08 06:00 [medline]
PHST- 2017/06/01 06:00 [entrez]
AID - peds.2016-3070 [pii]
AID - 10.1542/peds.2016-3070 [doi]
PST - ppublish
SO  - Pediatrics. 2017 Jun;139(6):e20163070. doi: 10.1542/peds.2016-3070. Epub 2017 May 
      4.