EMA 建议限制使用乌利司他(ulipristal)在子宫肌瘤中的使用
由于出现重度肝损伤病例,欧洲药品管理局(European Medicines Agency, EMA)建议对乌利司他的使用加以限制。[81]
此前,EMA 药物警戒风险评估委员会(Pharmacovigilance Risk Assessment Committee, PRAC)建议撤销药物在欧洲的上市许可。[82] 但是,经过慎重考虑,他们已经证实,对于无其他治疗选择患者,乌利司他对控制子宫肌瘤的获益可能超过该风险。因此,他们现在建议仍然可使用乌利司他治疗无法接受手术的绝经前患者(或手术后无明显效果者)。乌利司他勿用于待手术治疗患者控制子宫肌瘤。
2018 年,在重度肝损伤(包括导致移植的肝衰竭)得以报道后,EMA 对乌利司他治疗子宫肌瘤的获益和风险进行了审查,已采取措施将其风险最小化。[83] 然而,尽管遵循风险最小化措施,但此类病例之后又发生了另一例重度肝损伤,导致肝移植,因此 EMA 在 2020 年初启动了新的安全性审查。英国药品和医疗产品监管署 (Medicines and Healthcare products Regulatory Agency, MHRA) 也发布了乌利司他药物安全更新说明,提出了相似的建议。[85]
在一些国家,乌利司他被批准用于紧急避孕单剂量给药;此类限制不适用于该指征。
原始更新来源external link opens in a new window
小结
定义
病史和体格检查
诊断性检查
治疗流程
撰稿人
作者

Medical Director
Reproductive Endocrinology & Infertility
Baptist Medical Center
San Antonio Reproductive Associates
San Antonio
TX
利益声明
MM declares that he has no competing interests.

Laboratory Director
San Antonio Reproductive Associates
Odessa Reproductive Medicine Center
San Antonio
TX
利益声明
IE declares that she has no competing interests.
Dr Mitwally and Dr Elnahhas would like to gratefully acknowledge Dr Robert J. Fischer the previous contributor to this topic. RJF declares that he has no competing interests.
同行评议者
Chairman
Department of Obstetrics and Gynecology
Naval Medical Center
Portsmouth
VA
利益声明
EM declares that he has no competing interests.
Doctor
Department of Obstetrics and Gynecology
Naval Medical Center
Portsmouth
VA
利益声明
AN declares that she has no competing interests.
Consultant Gynaecologist
University Department of Obstetrics and Gynaecology
Royal Free Hospital
London
UK
利益声明
AM declares that he has no competing interests.
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