PMID- 29631464
OWN - NLM
STAT- MEDLINE
DCOM- 20190826
LR  - 20190826
IS  - 1556-9519 (Electronic)
IS  - 1556-3650 (Linking)
VI  - 56
IP  - 11
DP  - 2018 Nov
TI  - Adverse events associated with opioid-containing cough and cold medications in 
      children.
PG  - 1162-1164
LID - 10.1080/15563650.2018.1459665 [doi]
AB  - BACKGROUND: Until recently most of the scrutiny of opioid-containing cough and 
      cold medications (CCMs) by the US Food and Drug Administration (FDA) was focused 
      on codeine, only recently shifting equal focus to those containing hydrocodone. 
      We characterized adverse events (AEs) in children <12 years old associated with 
      CCMs that include both an opioid and over-the-counter (OTC) ingredient. METHODS: 
      US cases from multiple sources collected as part of a safety surveillance program 
      were included if AEs followed exposure to combination CCMs containing codeine or 
      hydrocodone between January 2008 and December 2015. An expert panel reviewed 
      cases to identify causal relationship between exposure and AEs and identify 
      contributing factors. Each AE term was coded using the Medical Dictionary for 
      Regulatory Activities with preferred terms reported. RESULTS: One hundred and 
      fourteen of the 7035 (2%) cases reviewed involved an opioid-containing product. 
      Ninety-eight cases involved an AE at least potentially related to the opioid 
      ingredient (38 (39%) codeine; 60 (61%) hydrocodone). All three fatality cases 
      involved hydrocodone with an antihistamine. Among non-fatalities, somnolence, 
      lethargy, and/or respiratory depression were more commonly reported among 
      hydrocodone cases than codeine cases (86% vs. 61%; p = .005). DISCUSSION: These 
      safety surveillance data support the FDA's expanded label changes limiting opioid 
      CCMs for children.
FAU - Paul, Ian M
AU  - Paul IM
AUID- ORCID: 0000-0002-6344-8609
AD  - a Pediatrics & Public Health Sciences , Penn State College of Medicine , Hershey 
      , PA , USA.
FAU - Reynolds, Kate M
AU  - Reynolds KM
AD  - b Rocky Mountain Poison and Drug Center , Denver Health and Hospital Authority , 
      Denver , CO , USA.
FAU - Green, Jody L
AU  - Green JL
AD  - b Rocky Mountain Poison and Drug Center , Denver Health and Hospital Authority , 
      Denver , CO , USA.
LA  - eng
PT  - Journal Article
DEP - 20180410
PL  - England
TA  - Clin Toxicol (Phila)
JT  - Clinical toxicology (Philadelphia, Pa.)
JID - 101241654
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Antitussive Agents)
RN  - 0 (Nonprescription Drugs)
MH  - Analgesics, Opioid/*adverse effects/*therapeutic use
MH  - Antitussive Agents/*adverse effects/*therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Cough/*drug therapy
MH  - Female
MH  - Humans
MH  - Infant
MH  - Male
MH  - Nonprescription Drugs/*adverse effects
MH  - United States/epidemiology
OTO - NOTNLM
OT  - CNS/psychological
OT  - opioids
OT  - other
EDAT- 2018/04/11 06:00
MHDA- 2019/08/27 06:00
CRDT- 2018/04/11 06:00
PHST- 2018/04/11 06:00 [pubmed]
PHST- 2019/08/27 06:00 [medline]
PHST- 2018/04/11 06:00 [entrez]
AID - 10.1080/15563650.2018.1459665 [doi]
PST - ppublish
SO  - Clin Toxicol (Phila). 2018 Nov;56(11):1162-1164. doi: 
      10.1080/15563650.2018.1459665. Epub 2018 Apr 10.