Severe adverse effects of bromocriptine in lactation inhibition: a pharmacovigilance survey

BJOG : an International Journal of Obstetrics and Gynaecology
N BernardFrench Network of Regional Pharmacovigilance Centres

Abstract

To assess the nature and conditions of the occurrence of adverse drug reactions (ADRs) of bromocriptine, which is used to inhibit lactation. Observational study. Cases from the French pharmacovigilance database and the marketing authorisation holders. Serious ADRs reported between 1994 and 2010 in association with bromocriptine used for lactation inhibition in France. 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. Number and description of serious ADRs, with a particular focus on misuse and associated predisposing factors. 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 ...Continue Reading

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Citations

Jun 15, 2016·The Australian & New Zealand Journal of Obstetrics & Gynaecology·Martien SnellenMegan Galbally
Jul 5, 2016·Pharmacotherapy·Benjamin LaliberteCarissa M Baker-Smith
Oct 21, 2016·Expert Review of Clinical Immunology·Vincent SobanskiEric Hachulla
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Oct 14, 2017·European Journal of Heart Failure·Uri Elkayam
Feb 8, 2018·Pharmaceutical Research·Philip O Anderson
Feb 1, 2019·BMJ : British Medical Journal·Michael C Honigberg, Michael M Givertz
Nov 3, 2021·Heart Failure Reviews·Angkawipa TrongtorsakSandra Chaparro

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