Chen Lin, Bao Rui, Tian Xiaojiang
Department of Pharmacy, Women and Children's Hospital of Chongqing Medical University, CHONGQING, 400021, China.
Department of Pharmacy, Chongqing Health Center for Women and Children, CHONGQING, China, Postal code 400021.
Heliyon. 2024 Aug 28;10(17):e37112. doi: 10.1016/j.heliyon.2024.e37112. eCollection 2024 Sep 15.
The levonorgestrel-releasing intrauterine system (LNG-IUS) is an established, long-acting contraceptive option. With the widespread use of the LNG-IUS, drug-reported adverse events (AEs) have also garnered significant attention. In this study, we conducted a real-world analysis using the FDA's Adverse Event Reporting System (FAERS) database to assess the incidence of AEs associated with LNG-IUS use. Data from FAERS spanning from 2004Q1 to 2024Q1 were reviewed, with a focus on reports in which LNG-IUS was the primary suspected and secondary suspect drug. Signal detection was carried out utilizing Standardized MedDRA Queries (SMQ) and Preferred Terms (PT), with reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC) employed to identify Signals of Disproportionate Reporting (SDR) for AEs. A positive SDR was defined when all three methods indicated significance. Analysis of 13 SMQs revealed notable SDRs in ear and eye disorders, cardiac arrhythmias, and lipodystrophy. Of the 61 suspected SDRs identified at the PT level, nearly half were not previously documented in labeling. Key potential signals of AEs associated with LNG-IUS use included increased heart rate, papilledema, idiopathic intracranial hypertension, cervical dysplasia, ruptured ovarian cyst, and uterine embedment and perforation. The findings underscore the importance of signal detection using FAERS data for identifying safety concerns related to LNG-IUS. Long-term observational studies are warranted to confirm and further elucidate these potential safety signals.
左炔诺孕酮宫内节育系统（LNG-IUS）是一种成熟的长效避孕选择。随着LNG-IUS的广泛使用，药物报告的不良事件（AE）也受到了广泛关注。在本研究中，我们使用美国食品药品监督管理局（FDA）的不良事件报告系统（FAERS）数据库进行了一项真实世界分析，以评估与使用LNG-IUS相关的AE发生率。回顾了FAERS从2004年第一季度到2024年第一季度的数据，重点关注LNG-IUS为主要可疑药物和次要可疑药物的报告。利用标准化医学术语集查询（SMQ）和首选术语（PT）进行信号检测，采用报告比值比（ROR）、比例报告比值（PRR）和信息成分（IC）来识别AE的不成比例报告信号（SDR）。当所有三种方法均显示有统计学意义时，定义为阳性SDR。对13个SMQ的分析显示，在耳部和眼部疾病、心律失常和脂肪代谢障碍方面存在显著的SDR。在PT水平上确定的61个可疑SDR中，近一半在标签中未曾记录。与使用LNG-IUS相关的AE的关键潜在信号包括心率加快、视乳头水肿、特发性颅内高压、宫颈发育异常、卵巢囊肿破裂以及子宫嵌入和穿孔。这些发现强调了利用FAERS数据进行信号检测以识别与LNG-IUS相关的安全问题的重要性。有必要进行长期观察性研究以确认并进一步阐明这些潜在的安全信号。
