PDF(Pubmed)
Abstract：
Tafamidis is the world\'s first and only oral drug approved to treat the rare disease transthyretin amyloid cardiomyopathy (ATTR-CM). Medicines are known to have different adverse reactions during the course of treatment. However, the current limited clinical studies did not identify significant adverse drug reactions to tafamidis. Tafamidis has been on the market for 5 years now, a large number of adverse drug event (ADE) reports with tafamidis as the primary suspected drug have been reported in the United Food and Drug Administration\'s adverse event reporting system (FAERS). We retrieved 8170 adverse event reports in FAERS with tafamidis as the first suspected drug, and mined these reports for positive signals to perform risk warnings for potentially possible adverse events with tafamidis. We found that a large number of adverse events associated with the primary disease were reported due to insufficient awareness of ATTR among the reporters, leading to a large number of positive signals reported in the cardiac disorders system. We also found that tafamidis has the potential to cause an adverse event risks of ear and labyrinth disorders system and urinary tract infection bacterial, which deserve continued clinical attention.
摘要：
Tafamidis是世界上第一个也是唯一一个被批准用于治疗罕见疾病转甲状腺素蛋白淀粉样心肌病（ATTR-CM）的口服药物。已知药物在治疗过程中有不同的不良反应。然而,目前有限的临床研究未发现对他法米的显著不良反应.Tafamidis已经上市5年了，美国食品和药物管理局的不良事件报告系统(FAERS)已经报告了大量以tafamidis为主要可疑药物的不良药物事件(ADE)报告.我们在FAERS中检索了8170份不良事件报告，其中Tafamidis是第一个可疑药物，并挖掘这些报告中的积极信号，以对tafamidis潜在可能的不良事件进行风险警告。我们发现，由于报告者对ATTR的认识不足，报告了大量与原发疾病相关的不良事件，导致心脏疾病系统中报告的大量阳性信号。我们还发现，tafamidis有可能引起耳和迷宫系统疾病和尿路感染细菌的不良事件风险，值得临床继续关注。
