Centre de Pharmacovigilance - Centre Antipoison, Hospices Civils de Lyon, Lyon, France.
Centre de Pharmacovigilance, CHU de Brest, Hôpital de la Cavale Blanche, Brest, France.
BJOG. 2015 Aug;122(9):1244-51. doi: 10.1111/1471-0528.13352. Epub 2015 Mar 11.
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 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.
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.
评估用于抑制泌乳的溴隐亭的不良反应（ADR）的性质和发生条件。
观察性研究。
来自法国药物警戒数据库和上市许可持有人的病例。
1994 年至 2010 年间报告的与法国用于抑制泌乳的溴隐亭相关的严重 ADR。
检查每个病例以确认溴隐亭的适应症、ADR 的严重程度、溴隐亭的使用方式，并识别可能的相关诱发因素。
严重 ADR 的数量和描述，特别关注误用和相关诱发因素。
在 105 例严重 ADR 中，包括两例死亡病例，最常见的是心血管（70.5%）、神经（14.3%）和精神（8.6%）疾病。心血管疾病主要包括缺血表现（n = 47）：急性缺血性中风（n = 18，一例死亡）、心肌梗死（n = 11，一例死亡）和可逆性产后脑血管病（n = 10）。在 52 例心血管疾病（70.3%）中发现了误用，主要是在出现提示 ADR 的首发症状或溴隐亭未逐渐滴定的情况下继续使用溴隐亭。这些妇女中有一半人有心血管诱发因素，主要是吸烟、超重或肥胖，或有高血压或子痫前期病史。
这项调查与已发表的数据一起，进一步证明了在抑制泌乳中使用溴隐亭后仍会发生严重的 ADR，而且这些 ADR 中的大多数本可以避免。因此，溴隐亭的使用应仅限于没有其他选择来抑制泌乳的情况下。
