Jödicke Annika M, Dahmke Hendrike, Damke Beat, Schäublin Martina, Kullak-Ublick Gerd A, Weiler Stefan
Regional Pharmacovigilance Centre Zurich, Department of Clinical Pharmacology and Toxicology, University Hospital Zurich and University of Zurich, Switzerland.
Swissmedic, Bern, Switzerland.
Swiss Med Wkly. 2017 May 10;147:w14432. doi: 10.4414/smw.2017.14432. eCollection 2017.
Sayana® was introduced as the first depot medroxyprogesterone acetate-containing contraceptive that is administered via subcutaneous injection. Within 10 months, the Regional Pharmacovigilance Centre (RPVC) Zurich received several anonymous reports of serious local reactions after Sayana® administration. In this retrospective study, individual case safety reports (ICSRs) on local adverse drug reactions (ADRs) related to Sayana® were analysed from the WHO pharmacovigilance database.
International, national and regional ICSRs during Sayana® administration up to 1 January 2016 were examined. Data on ADRs were retrieved from the WHO Global Database VigiBase™. Demographic data, drug administration information, duration of Sayana® treatment, latency time of the ADR, and its course, severity and outcomes were analysed.
Worldwide, 398 ICSRs after Sayana® use were registered in the database. We identified 20 reported terms that were potentially used to describe a persistent lipodystrophy. When only cases containing one or more of these 20 reported terms were selected, 323 (81.2%) international ICSRs remained for analysis. Of those, 91.6% (n = 296) were categorised as serious. The majority of the reactions (n = 193, 54.4%) did not recover. In the 67 Swiss ICSRs, 77 ADRs were reported using 10 different terms including severe or persistent local reactions like lipodystrophy, atrophy or fat necrosis. Thirty-two patients (47.7%) did not recover. All 11 regional cases reported to the RPVC Zurich were categorised as serious ADRs. For the majority of the patients (n = 7, 63.6%) the interval between the application of Sayana® and development of the lipodystrophy was between 2 and 4 months. Most of the reactions were irreversible (n = 9, 81.8%). One patient underwent plastic surgery for artificial infill of the dent.
Persistent local injection site reactions such as lipodystrophy, fat tissue necrosis or atrophy occur frequently after subcutaneous Sayana® use. These adverse drug reactions were recently integrated in the Swiss product information. Physicians and patients should be informed and advised about these potentially irreversible effects.
Sayana®是首款通过皮下注射给药的含醋酸甲羟孕酮长效避孕针。在10个月内，苏黎世地区药物警戒中心（RPVC）收到了几例关于使用Sayana®后出现严重局部反应的匿名报告。在这项回顾性研究中，从世界卫生组织药物警戒数据库分析了与Sayana®相关的局部药物不良反应（ADR）的个体病例安全报告（ICSR）。
检查了截至2016年1月1日使用Sayana®期间的国际、国家和地区ICSR。从世界卫生组织全球数据库VigiBase™中检索ADR数据。分析了人口统计学数据、药物给药信息、Sayana®治疗持续时间、ADR的潜伏时间及其病程、严重程度和结局。
在全球范围内，数据库中登记了398例使用Sayana®后的ICSR。我们确定了20个报告术语，可能用于描述持续性脂肪营养不良。当仅选择包含这20个报告术语中的一个或多个的病例时，仍有323份（81.2%）国际ICSR用于分析。其中，91.6%（n = 296）被归类为严重。大多数反应（n = 193，54.4%）未恢复。在67份瑞士ICSR中，使用10个不同术语报告了77例ADR，包括严重或持续性局部反应，如脂肪营养不良、萎缩或脂肪坏死。32例患者（47.7%）未恢复。向苏黎世RPVC报告的所有11例地区病例均被归类为严重ADR。对于大多数患者（n = 7，63.6%），使用Sayana®与出现脂肪营养不良之间的间隔为2至4个月。大多数反应是不可逆的（n = 9，81.8%）。一名患者接受了整形手术以人工填充凹陷处。
皮下使用Sayana®后，经常会出现持续性局部注射部位反应，如脂肪营养不良、脂肪组织坏死或萎缩。这些药物不良反应最近已纳入瑞士产品说明书中。应告知医生和患者这些潜在的不可逆影响。
