title: Severe adverse effects of bromocriptine in lactation inhibition: a pharmacovigilance survey.
abstract: OBJECTIVE
  To assess the nature and conditions of the occurrence of adverse drug reactions (ADRs) of bromocriptine, which is used to inhibit lactation.
  
  
  METHODS
  Observational study.
  
  
  METHODS
  Cases from the French pharmacovigilance database and the marketing authorisation holders.
  
  
  METHODS
  Serious ADRs reported between 1994 and 2010 in association with bromocriptine used for lactation inhibition in France.
  
  
  METHODS
  Each case was checked to confirm the bromocriptine indication, the seriousness of the ADR, the modalities of bromocriptine use, and to identify possible associated predisposing factors.
  
  
  METHODS
  Number and description of serious ADRs, with a particular focus on misuse and associated predisposing factors.
  
  
  RESULTS
  Among 105 serious ADRs, including two fatal cases, the most frequent were cardiovascular (70.5%), neurological (14.3%), and psychiatric (8.6%) disorders. Cardiovascular disorders primarily consisted of ischaemic manifestations (n = 47): acute ischaemic stroke (n = 18, one death), myocardial infarction (n = 11, one death), and reversible postpartum cerebral angiopathy (n = 10). Misuse was identified in 52 cases (70.3%) of cardiovascular disorders, and mostly consisted of bromocriptine continuation despite the occurrence of first symptoms suggesting an ADR or the absence of a progressive titration of bromocriptine. About half of these women had cardiovascular predisposing factors, mainly tobacco smoking, overweight or obesity, or a history of hypertension or pre-eclampsia.
  
  
  CONCLUSIONS
  This survey, together with published data, provides further evidence that serious ADRs still occur after bromocriptine use in lactation inhibition, and that most of these ADRs could have been avoided. The use of bromocriptine should therefore be limited to cases where no other options are available to inhibit lactation.
authors.affiliation: Centre de Pharmacovigilance - Centre Antipoison, Hospices Civils de Lyon, Lyon, France.
authors.forename: N
authors.initials: N
authors.lastname: Bernard
authors.affiliation: Centre de Pharmacovigilance, CHU de Brest, Hôpital de la Cavale Blanche, Brest, France.
authors.forename: H
authors.initials: H
authors.lastname: Jantzem
authors.affiliation: Centre de Pharmacovigilance, Hôpital Central, Nancy, France.
authors.forename: M
authors.initials: M
authors.lastname: Becker
authors.affiliation: Centre de Pharmacovigilance, Groupe Hospitalier Cochin, Bâtiment Lavoisier, Paris, France.
authors.forename: C
authors.initials: C
authors.lastname: Pecriaux
authors.affiliation: Centre de Pharmacovigilance, CHU de Bordeaux, Bordeaux, France.
authors.forename: A
authors.initials: A
authors.lastname: Bénard-Laribière
authors.affiliation: Service de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, équipe de pharmacoépidémiologie, UMR INSERM 1027, Faculté de Médecine, Centre Hospitalo-universitaire, Toulouse, France.
authors.forename: J L
authors.initials: JL
authors.lastname: Montastruc
authors.affiliation: Centre de Pharmacovigilance - Centre Antipoison, Hospices Civils de Lyon, Lyon, France.
authors.forename: J
authors.initials: J
authors.lastname: Descotes
authors.affiliation: Centre de Pharmacovigilance - Centre Antipoison, Hospices Civils de Lyon, Lyon, France.
authors.forename: T
authors.initials: T
authors.lastname: Vial
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D001971:Bromocriptine / Q000008:administration & dosage / Q000009:adverse effects*; D015984:Causality; D002561:Cerebrovascular Disorders / Q000139:chemically induced* / Q000453:epidemiology; D018491:Dopamine Agonists / Q000008:administration & dosage / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005602:France / Q000453:epidemiology; D006801:Humans; D006973:Hypertension / Q000139:chemically induced* / Q000453:epidemiology; D007774:Lactation / Q000187:drug effects*; D009203:Myocardial Infarction / Q000139:chemically induced* / Q000453:epidemiology; D060735:Pharmacovigilance; D010818:Practice Patterns, Physicians'; D055553:Prescription Drugs / Q000009:adverse effects; D020521:Stroke / Q000139:chemically induced* / Q000453:epidemiology
chemical_list: D018491:Dopamine Agonists; D055553:Prescription Drugs; D001971:Bromocriptine
keywords: Bromocriptine; cardiovascular diseases; lactation inhibition; misuse; postpartum period