Regional Center for Pharmacovigilance and Pharmacoepidemiology, Reims University Hospitals, France.
Drug Saf. 2011 Dec 1;34(12):1161-6. doi: 10.2165/11595660-000000000-00000.
Hyperprolactinaemia is a common endocrinological disorder that can be caused by a variety of physiological and pathological conditions, although in a large proportion of cases hyperprolactinaemia is drug-induced. Serotonin reuptake inhibitors (SRIs) are reportedly associated with hyperprolactinaemia; however, the number of published cases in the literature is limited.
The aim of the study was to investigate the association between exposure to SRIs and the risk of reporting of hyperprolactinaemia in a spontaneous reporting database.
All cases of adverse drug reactions (ADRs) involving hyperprolactinaemia spontaneously reported to the French Pharmacovigilance Database from 1985 to December 2009 were reviewed. Cases of hyperprolactinaemia in SRI users were described. In a case/non-case analysis, the association between reported cases of hyperprolactinaemia and the use of SRIs was assessed by calculating reporting odds ratios (ROR) with their 95% confidence intervals (CIs).
A total of 11 863 reports with SRIs were collected, of which 187 reported hyperprolactinaemia ADRs. Subjects were 39.7 ± 13.5 years of age on average and mainly female (71%). We observed an increased risk of reporting of hyperprolactinaemia with the use of SRIs as antidepressants (overall ROR 3.3; 95% CI 2.8, 3.8), particularly with fluvoxamine (ROR 4.5; 95% CI 2.8, 7.2), citalopram (ROR 3.9; 95% CI 2.6, 5.8), fluoxetine (ROR 3.6; 95% CI 2.8, 4.7) and paroxetine (ROR 3.1; 95% CI 2.3, 4.2). Duloxetine, milnacipran and sertraline were not associated with an increased risk of reporting of hyperprolactinaemia.
Treatment with SRIs is associated with an increased risk of reported hyperprolactinaemia. When investigating the aetiology of diagnosed hyperprolactinaemia, physicians should systematically enquire about treatment with SRIs. The risk of hyperprolactinaemia should be mentioned in the labelling of all SRI compounds.
高催乳素血症是一种常见的内分泌紊乱，可由多种生理和病理状况引起，尽管在很大比例的病例中，高催乳素血症是药物引起的。据报道，选择性 5-羟色胺再摄取抑制剂（SSRIs）与高催乳素血症有关；然而，文献中发表的病例数量有限。
本研究旨在调查在自发报告数据库中，SSRIs 暴露与报告高催乳素血症风险之间的关联。
从 1985 年至 2009 年 12 月，对法国药物警戒数据库中自发报告的所有涉及高催乳素血症的药物不良反应（ADR）病例进行了审查。描述了 SSRIs 使用者中高催乳素血症病例。在病例/非病例分析中，通过计算报告比值比（ROR）及其 95%置信区间（CI），评估报告的高催乳素血症病例与 SSRIs 使用之间的关联。
共收集了 11863 例含有 SSRIs 的报告，其中 187 例报告了高催乳素血症 ADR。受试者的平均年龄为 39.7±13.5 岁，主要为女性（71%）。我们观察到使用 SSRIs 作为抗抑郁药时，高催乳素血症报告的风险增加（总体 ROR 为 3.3；95%CI 为 2.8，3.8），特别是氟伏沙明（ROR 为 4.5；95%CI 为 2.8，7.2）、西酞普兰（ROR 为 3.9；95%CI 为 2.6，5.8）、氟西汀（ROR 为 3.6；95%CI 为 2.8，4.7）和帕罗西汀（ROR 为 3.1；95%CI 为 2.3，4.2）。度洛西汀、米那普仑和舍曲林与高催乳素血症报告风险增加无关。
使用 SSRIs 治疗与报告的高催乳素血症风险增加有关。在调查诊断为高催乳素血症的病因时，医生应系统询问使用 SSRIs 的情况。所有 SSRIs 化合物的标签均应提及高催乳素血症的风险。
