Indraccolo Ugo, Conzadori Sara, Greco Pantaleo
Complex Operative Unit of Obstetrics and Gynecology, Azienda Ospedaliero-Universitaria of Ferrara, Arcispedale Sant'Anna, Cona-Ferrara.
Department of Morphology, Surgery and Experimental Medicine, Section of Obstetrics and Gynecology, University of Ferrara.
Recenti Prog Med. 2019 Feb;110(2):98-99. doi: 10.1701/3112.31006.
The 19 of February 2018 the Italian Medicines Agency (AIFA - Agenzia Italiana del Farmaco) temporary stopped the new administration of Ulipristal Acetate (UPA) for treating uterine leiomyomas symptoms, because liver injury and hepatic failure had been reported in relationship with UPA use. After the European Medicines Agency review of risks of UPA, the 3 of August 2018 the AIFA produced another note, disclosing that a cause-effect relationship between the UPA use and liver injury is not proved and that some patients can be discontinuously treated if surgery is not recommended. However, a close monitoring of hepatic function must be done in Ulipristal users. As Ulipristal has not been prescribed since February 2018 in our center, the rate of surgical operations for uterine leiomyomas significantly doubled. Therefore it will be useful know exactly which restricted indications allow to use UPA for more than 3 months. In this way it could be minimized the risks of liver injury and it could be prevented the rise of surgeries for uterine leiomyomas.
2018年2月19日，意大利药品管理局（AIFA - 意大利药品管理局）暂时停止了醋酸乌利司他（UPA）用于治疗子宫平滑肌瘤症状的新给药，因为有报告称肝损伤和肝衰竭与UPA的使用有关。在欧洲药品管理局对UPA的风险进行审查后，2018年8月3日，AIFA发布了另一则通知，披露UPA使用与肝损伤之间的因果关系未得到证实，并且如果不建议手术，一些患者可以间断治疗。然而，必须对使用乌利司他的患者进行肝功能密切监测。由于自2018年2月以来我们中心未再开具乌利司他，子宫平滑肌瘤的手术率显著翻倍。因此，确切了解哪些受限适应症允许使用UPA超过3个月将是有用的。这样可以将肝损伤风险降至最低，并防止子宫平滑肌瘤手术量的增加。
