Dopamine agonists have been associated with an increased risk of developing impulse control disorders (ICDs). The US Food and Drug Administration (FDA) issued a safety warning in 2016 of a possible association between ICDs and aripiprazole. Recently, one large epidemiological study has confirmed this risk. In the present study, we aim to determine whether the safety signal of ICDs associated with aripiprazole detected by the FDA is replicated in the European pharmacovigilance database (EudraVigilance). We searched for all suspected spontaneous cases of ICDs associated with aripiprazole in EudraVigilance up to 23 February 2017. To assess the association between ICD cases and each dopamine agonist drug, we calculated the proportional reporting ratios (PRRs). Among 4 905 110 events of all types recorded in EudraVigilance, we found 160 cases of ICDs associated with aripiprazole. Aripiprazole fulfilled the criteria to generate a safety signal; PRR (95% confidence interval): 16.39 (13.97-19.24). Notably, the association seemed the strongest for the depot formulation of aripiprazole; PRR (95% confidence interval): 27.13 (17.22-42.75). Our analysis of the data contained in EudraVigilance confirms the safety signal detected last year by the FDA. Interestingly, for the first time, we show that the association seems the strongest for the intramuscular depot formulation of aripiprazole.

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阿立哌唑和冲动控制障碍：肌肉注射制剂风险更高？

多巴胺激动剂与发生冲动控制障碍（ICD）的风险增加有关。美国食品药品监督管理局（FDA）在2016年发布了安全警告，警告说ICD与阿立哌唑之间可能存在关联。最近，一项大型流行病学研究已经证实了这种风险。在本研究中，我们旨在确定由FDA检测到的与阿立哌唑相关的ICD的安全性信号是否在欧洲药物警戒数据库（EudraVigilance）中复制。我们搜索了截至2017年2月23日在EudraVigilance中所有与阿立哌唑有关的ICD疑似自发病例。为了评估ICD病例与每种多巴胺激动剂之间的关联，我们计算了比例报告比率（PRR）。在EudraVigilance中记录的4905110种所有类型的事件中，我们发现了160例与阿立哌唑有关的ICD。阿立哌唑符合产生安全信号的标准；PRR（95％置信区间）：16.39（13.97-19.24）。值得注意的是，对于阿立哌唑的制剂而言，该关联似乎最强。PRR（95％置信区间）：27.13（17.22-42.75）。我们对EudraVigilance中包含的数据的分析证实了FDA去年检测到的安全信号。有趣的是，我们首次显示出这种联系对于阿立哌唑的肌肉内制剂似乎是最强的。我们对EudraVigilance中包含的数据的分析证实了FDA去年检测到的安全信号。有趣的是，我们第一次显示出这种联系对于阿立哌唑的肌肉内制剂似乎是最强的。我们对EudraVigilance中包含的数据的分析证实了FDA去年检测到的安全信号。有趣的是，我们第一次显示出这种联系对于阿立哌唑的肌肉内制剂似乎是最强的。