Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, Raebareli (NIPER-R), Lucknow (UP) -226002, India.
CNS Neurol Disord Drug Targets. 2020;19(2):109-114. doi: 10.2174/1871527319666200303120147.
Lurasidone was approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia, as well as for the treatment of bipolar depression. However, emerging reports have indicated various adverse drug reactions with the use of lurasidone. Thus, in this article, we have analyzed the risk profile of lurasidone in the established therapeutic indication. A total of 419 studies were published from October 2010-July 2019 regarding lurasidone. After the inclusion and exclusion criteria, 17 studies were selected for the analysis of risk. The adverse drug reactions (ADRs) of these studies were categorized as per the innovator summary of product characteristics (SmPC). Finally, the unlisted ADRs were analyzed by using the Naranjo probability algorithm. Telogen effluvium, thrombocytopenia, restless leg syndrome and hypersexuality were found with the use of lurasidone and fall under the unlisted category. The causality assessment has shown a probable correlation of lurasidone with hypersexuality, restless leg syndrome, thrombocytopenia and possible relation with telogen effluvium. In conclusion, lurasidone is a novel and efficacious pharmacological treatment for bipolar depression and schizophrenia. However, more data regarding the safety of this drug in a large population is needed.
鲁拉西酮已获美国食品药品监督管理局（FDA）批准，用于治疗精神分裂症和双相情感障碍的抑郁症。然而，新出现的报告表明，使用鲁拉西酮会引起各种不良反应。因此，在本文中，我们分析了鲁拉西酮在既定治疗适应证中的风险概况。共有 419 项研究于 2010 年 10 月至 2019 年 7 月发表，涉及鲁拉西酮。在纳入和排除标准后，选择了 17 项研究进行风险分析。这些研究的药物不良反应（ADR）按照原研药产品特性摘要（SmPC）进行分类。最后，使用 Naranjo 概率算法分析了未上市的 ADR。使用鲁拉西酮时发现休止期脱发、血小板减少症、不宁腿综合征和性欲亢进等不良反应，且这些不良反应均属于未上市类别。因果关系评估表明，鲁拉西酮与性欲亢进、不宁腿综合征、血小板减少症可能具有相关性，与休止期脱发可能具有相关性。总之，鲁拉西酮是一种新型有效的治疗双相情感障碍和精神分裂症的药理学药物。然而，需要更多关于这种药物在大人群中的安全性数据。
