title: [Psychiatric disorders associated with montelukast: data from the National Pharmacovigilance Database].
abstract: Montelukast (Singulair(®)) 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.
authors: Service de pharmacologie clinique, centre régional de pharmacovigilance et d'information sur le médicament, CHRU de Tours, 2, boulevard Tonnellé, 37044 Tours, cedex 9, France. marie-sara.marchand@hotmail.com
authors: M-S
authors: MS
authors: Marchand
authors: A-P
authors: AP
authors: Jonville-Béra
authors: E
authors: E
authors: Autret-Leca
mesh_terms: D000085:Acetates / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D003521:Cyclopropanes; D016208:Databases, Factual; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced*; D008875:Middle Aged; D060735:Pharmacovigilance; D011804:Quinolines / Q000009:adverse effects*; D013440:Sulfides; D055815:Young Adult
chemical_list: D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast