PMID- 27062190
OWN - NLM
STAT- MEDLINE
DCOM- 20170320
LR  - 20170320
IS  - 1769-664X (Electronic)
IS  - 0929-693X (Linking)
VI  - 23
IP  - 5
DP  - 2016 May
TI  - [Adverse drug reactions in children: 10 years of pharmacovigilance].
PG  - 468-76
LID - S0929-693X(16)30071-9 [pii]
LID - 10.1016/j.arcped.2016.01.015 [doi]
AB  - BACKGROUND: Knowledge of drug tolerance and safety in children is limited. The 
      study of spontaneous notifications of adverse events (AEs) can be an important 
      source of information. OBJECTIVE: Describe the characteristics of drug adverse 
      effects (DAEs) in children 0-17 years of age reported to the pharmacovigilance 
      center of Saint-Etienne in 2004-2013. METHODS: This retrospective descriptive 
      study was conducted based on DAE notifications, classified according to age, sex, 
      severity of organ affected (using classification by the System organ class [SOC]) 
      and by suspected drug (Anatomical therapeutic chemical [ATC] drugs). RESULTS: A 
      total of 371 notifications were analyzed. The male:female ratio was 1. Serious 
      cases accounted for 36%, of which 73% resulted in hospitalization or prolongation 
      of hospitalization. The most frequent DAEs were cutaneous (21.1%), infection 
      (13.5%) and general (11.5%). The most frequently involved therapeutic classes 
      were anti-infectives for systemic use (38.7%), mainly vaccines and antibiotics, 
      as well as antineoplastic and immunomodulatory therapy (19.2%) and drugs acting 
      on the nervous system (12.5%). CONCLUSIONS: The analysis of notifications of 
      adverse drug reactions is an important source of information and is underutilized 
      in pediatrics. The data from this study confirm those of European databases with 
      spontaneous reporting. The majority of anti-infectives including antibiotics 
      raises the question of the proper use of this class in this population. Larger 
      studies focused on the drugs at risk would improve the knowledge and safe use of 
      medicines in children.
CI  - Copyright (c) 2016 Elsevier Masson SAS. All rights reserved.
FAU - Damien, S
AU  - Damien S
AD  - Faculte de medecine Jacques-Lisfranc de Saint-Etienne, 42055 Saint-Etienne, 
      France.
FAU - Patural, H
AU  - Patural H
AD  - Unites de reanimation neonatale et pediatrique, pole Mere-Enfant, centre 
      hospitalo-universitaire de Saint-Etienne, avenue Albert-Raimond, 42055 
      Saint-Etienne cedex 02, France. Electronic address: 
      hugues.patural@chu-st-etienne.fr.
FAU - Trombert-Paviot, B
AU  - Trombert-Paviot B
AD  - Departement de Sante publique, hopital Nord, CHU de Saint-Etienne, 42055 
      Saint-Etienne, France.
FAU - Beyens, M-N
AU  - Beyens MN
AD  - Centre regional de pharmacovigilance, hopital Nord, CHU de Saint-Etienne, 42055 
      Saint-Etienne, France.
LA  - fre
PT  - Journal Article
TT  - Effets indesirables medicamenteux chez l'enfant : 10ans de pharmacovigilance.
DEP - 20160406
PL  - France
TA  - Arch Pediatr
JT  - Archives de pediatrie : organe officiel de la Societe francaise de pediatrie
JID - 9421356
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Anti-Infective Agents)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Immunologic Factors)
RN  - 0 (Vaccines)
SB  - IM
MH  - Adolescent
MH  - Anti-Bacterial Agents/*adverse effects
MH  - Anti-Infective Agents/adverse effects
MH  - Antineoplastic Agents/*adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Female
MH  - France/epidemiology
MH  - Humans
MH  - Immunologic Factors/*adverse effects
MH  - Infant
MH  - Male
MH  - *Pharmacovigilance
MH  - Retrospective Studies
MH  - Risk Factors
MH  - Sex Distribution
MH  - Vaccines/*adverse effects
EDAT- 2016/04/12 06:00
MHDA- 2017/03/21 06:00
CRDT- 2016/04/11 06:00
PHST- 2015/05/18 00:00 [received]
PHST- 2015/11/15 00:00 [revised]
PHST- 2016/01/29 00:00 [accepted]
PHST- 2016/04/11 06:00 [entrez]
PHST- 2016/04/12 06:00 [pubmed]
PHST- 2017/03/21 06:00 [medline]
AID - S0929-693X(16)30071-9 [pii]
AID - 10.1016/j.arcped.2016.01.015 [doi]
PST - ppublish
SO  - Arch Pediatr. 2016 May;23(5):468-76. doi: 10.1016/j.arcped.2016.01.015. Epub 2016 
      Apr 6.