PMID- 23375423
OWN - NLM
STAT- MEDLINE
DCOM- 20130826
LR  - 20211203
IS  - 1769-664X (Electronic)
IS  - 0929-693X (Linking)
VI  - 20
IP  - 3
DP  - 2013 Mar
TI  - [Psychiatric disorders associated with montelukast: data from the National 
      Pharmacovigilance Database].
PG  - 269-73
LID - S0929-693X(12)00540-4 [pii]
LID - 10.1016/j.arcped.2012.12.006 [doi]
AB  - Montelukast (Singulair((R))) has been the subject of post-marketing warnings about 
      psychiatric events occurring that had not been identified during clinical trials. 
      The objective of this study was to take stock of the adverse events (AEs) related 
      to montelukast reported in France. Cases of psychiatric disorders reported to 
      regional pharmacovigilance centers (CRPV) and the literature data were analyzed. 
      The 56psychiatric AEs account for 20% of all AEs reported in the montelukast 
      CRPV: essentially sleep disorders, behavioral disorders and depression. This risk 
      is also found in pharmacovigilance databases in other countries, especially in 
      the North American database, which recorded a significant number of cases of 
      "suicidality", including suicidal ideation, suicide attempts, and suicides. 
      Analysis of clinical efficacy studies have failed to confirm these AEs. The 
      potential severity of these events prompts physicians to seek the existence of 
      psychiatric disorders before prescribing the drug and to carefully monitor the 
      occurrence of AEs during treatment.
CI  - Copyright (c) 2013 Elsevier Masson SAS. All rights reserved.
FAU - Marchand, M-S
AU  - Marchand MS
AD  - Service de pharmacologie clinique, centre regional de pharmacovigilance et 
      d'information sur le medicament, CHRU de Tours, 2, boulevard Tonnelle, 37044 
      Tours, cedex 9, France. marie-sara.marchand@hotmail.com
FAU - Jonville-Bera, A-P
AU  - Jonville-Bera AP
FAU - Autret-Leca, E
AU  - Autret-Leca E
CN  - Association francaise des centres regionaux de pharmacovigilance
LA  - fre
PT  - Journal Article
TT  - Troubles psychiatriques associes au montelukast : donnees de la base nationale de 
      pharmacovigilance.
DEP - 20130201
PL  - France
TA  - Arch Pediatr
JT  - Archives de pediatrie : organe officiel de la Societe francaise de pediatrie
JID - 9421356
RN  - 0 (Acetates)
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Cyclopropanes)
RN  - 0 (Quinolines)
RN  - 0 (Sulfides)
RN  - MHM278SD3E (montelukast)
SB  - IM
MH  - Acetates/*adverse effects
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Asthmatic Agents/*adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Cyclopropanes
MH  - Databases, Factual
MH  - Female
MH  - France
MH  - Humans
MH  - Male
MH  - Mental Disorders/*chemically induced
MH  - Middle Aged
MH  - Pharmacovigilance
MH  - Quinolines/*adverse effects
MH  - Sulfides
MH  - Young Adult
EDAT- 2013/02/05 06:00
MHDA- 2013/08/27 06:00
CRDT- 2013/02/05 06:00
PHST- 2012/07/24 00:00 [received]
PHST- 2012/11/11 00:00 [revised]
PHST- 2012/12/14 00:00 [accepted]
PHST- 2013/02/05 06:00 [entrez]
PHST- 2013/02/05 06:00 [pubmed]
PHST- 2013/08/27 06:00 [medline]
AID - S0929-693X(12)00540-4 [pii]
AID - 10.1016/j.arcped.2012.12.006 [doi]
PST - ppublish
SO  - Arch Pediatr. 2013 Mar;20(3):269-73. doi: 10.1016/j.arcped.2012.12.006. Epub 2013 
      Feb 1.