Department of Transplant Surgery, Brigham and Women's Hospital, Boston, MA, USA.
Am J Transplant. 2013 Jun;13(6):1383-9. doi: 10.1111/ajt.12238. Epub 2013 Apr 25.
The mycophenolic acid (MPA) preparations are one of the most commonly used immunosuppressants in the United States. However, these agents carry a black box warning regarding their use during pregnancy due to an association with increased risk of miscarriage and congenital defects. To ensure that the benefits of MPA outweigh the risks, the Food and Drug Administration (FDA) required all manufacturers of MPA products to propose risk evaluation and mitigation strategies (REMS). Four years after initially calling for proposals, the FDA approved a single shared REMS system in September 2012. The elements of the MPA REMS include a medication guide and elements to assure safe use (ETASU). The medication guide, which was previously FDA-approved in 2008, should continue to be distributed to patients, and the ETASU requires physicians to complete training and obtain patient signatures on the "Patient-Prescriber Acknowledgement Form." A single, national, voluntary pregnancy registry is available, and pregnant patients should be encouraged to participate. Although the impact of the MPA REMS on clinical practice is not clear, it is a step toward increasing the understanding of fetal risks with MPA products among patients and possibly practitioners.
霉酚酸（MPA）制剂是美国最常用的免疫抑制剂之一。然而，由于这些药物与流产和先天缺陷风险增加有关，因此在怀孕期间使用时带有黑框警告。为了确保 MPA 的益处超过风险，美国食品和药物管理局（FDA）要求所有 MPA 产品制造商提出风险评估和缓解策略（REMS）。在最初提出建议四年后，FDA 于 2012 年 9 月批准了一个单一的共享 REMS 系统。MPA REMS 的要素包括用药指南和确保安全使用的要素（ETASU）。用药指南于 2008 年获得 FDA 批准，应继续分发给患者，ETASU 要求医生完成培训并在“患者-处方者确认表”上获得患者签名。一个单一的、全国性的、自愿的妊娠登记处可用，应鼓励孕妇参加。尽管 MPA REMS 对临床实践的影响尚不清楚，但它是提高患者和可能的从业者对 MPA 产品胎儿风险认识的一步。
