Martins S, Costa S, Sousa M, Moreira F, Martín-Suaréz A, Jesus Â
LAQV/REQUIMTE, Escola Superior de Saúde, Instituto Politécnico do Porto, Rua Dr. António Bernardino de Almeida, 400, 4200-072 Porto, Portugal; Departamento de Ciencias Farmacéuticas, Universidad de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), Campus Miguel de Unamuno, E-37007, Salamanca, Spain; Instituto Português de Oncologia do Porto FG, EPE, Rua Dr. António Bernardino de Almeida, 4200-072 Porto, Portugal.
LAQV/REQUIMTE, Escola Superior de Saúde, Instituto Politécnico do Porto, Rua Dr. António Bernardino de Almeida, 400, 4200-072 Porto, Portugal.
Rev Esp Med Nucl Imagen Mol (Engl Ed). 2025 Jun 9:500166. doi: 10.1016/j.remnie.2025.500166.
Tc-tetrofosmin is a diagnostic radiopharmaceutical used to evaluate cardiac pathologies. Despite the lower incidence of reactions compared to other drugs, radiopharmaceuticals can still cause adverse reactions. For this reason, pharmacovigilance plays a crucial role in detecting, understanding, evaluating and preventing them.
This study aims to review the available literature,on the safety of Tc-tetrofosmin, and to analyze spontaneous adverse drug reaction reports from the European EudraVigilance database.
A literature review was conducted according to PRISMA methodology. An analysis of spontaneous notifications was carried out in EudraVigilance, until 2022.
The review identified a selection of 7 articles. The most reported adverse reactions were skin irritation, strange taste in the mouth and nausea. Regarding the EudraVigilance analysis, 220 notifications were identified, accounting for 477 adverse reactions. The majority belong to males (51%), between 18-64 years (45%). Health professionals were the main reporters (84%). The most prevalent System Organ Class was "general disorders and administration site conditions" (21%) and the most reported adverse reaction was pruritus (10%). Approximately 67% of reactions were considered serious, with 6 fatal cases recorded.
The results demonstrated that adverse reactions associated with Tc-tetrofosmin do occur and should not be minimized. Over a period of 17 years, only 220 notifications were recorded, which may highlight potential challenges in pharmacovigilance for radiopharmaceuticals. Therefore, raising awareness about the importance of reporting adverse reactions is crucial.
锝-替曲膦是一种用于评估心脏疾病的诊断性放射性药物。尽管与其他药物相比反应发生率较低，但放射性药物仍可能引起不良反应。因此，药物警戒在检测、理解、评估和预防这些反应方面起着至关重要的作用。
本研究旨在回顾有关锝-替曲膦安全性的现有文献，并分析来自欧洲药物警戒数据库的自发药物不良反应报告。
根据PRISMA方法进行文献综述。在欧洲药物警戒数据库中对自发报告进行分析，截至2022年。
该综述筛选出7篇文章。报告最多的不良反应是皮肤刺激、口腔异味和恶心。关于欧洲药物警戒分析，共识别出220份报告，涉及477例不良反应。大多数为男性（51%），年龄在18 - 64岁之间（45%）。医疗专业人员是主要报告者（84%）。最常见的系统器官类别是“全身性疾病和给药部位状况”（21%），报告最多的不良反应是瘙痒（10%）。约67%的反应被认为是严重的，记录到6例死亡病例。
结果表明，与锝-替曲膦相关的不良反应确实存在，不应被忽视。在17年的时间里，仅记录到220份报告，这可能凸显了放射性药物药物警戒方面的潜在挑战。因此，提高对报告不良反应重要性的认识至关重要。
