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Acute Renal Failure in a Patient with Rivaroxaban-Induced Hypersensitivity Syndrome: A Case Report with a Review of the Literature and of Pharmacovigilance Registries

机译:患有利伐沙巴班诱导的超敏反综合征的患者急性肾功能衰竭:一个案例报告,审查文献和药物检察官的审查

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Direct oral anticoagulants (DOACs) are among the most commonly prescribed medications, and DOAC-associated kidney dysfunction may be a problem that is underrecognized by clinicians. We report on the case of an 82-year-old patient who, two weeks after the prescription of rivaroxaban for atrial fibrillation, was hospitalized for a drug-induced hypersensitivity syndrome whose main clinical manifestations were low-grade fever with a petechial rash in the legs and acute renal failure (ARF). Within one week after rivaroxaban withdrawal, the patient’s clinical condition improved and the renal function normalized. In a review of the literature, we only found five case reports of rivaroxaban-related ARF: two patients had tubulo-interstitial nephritis (TIN), two had anticoagulant-related nephropathy (ARN), and the last one had IgA nephropathy. As some recent publications suggest that kidney injury due to anticoagulation drugs may be largely underdiagnosed, we also analyzed the data from the VigiAccess database, the World Health Organization pharmacovigilance program that collects drug-related adverse events from 134 national registries worldwide. Among all the rivaroxaban-associated adverse events reported in VigiAccess since 2006, 4,323 (3.5%) were renal side effects, of which 2,351 (54.3%) were due to unspecified ARF, 363 (8.4%) were due to renal hemorrhage (characteristically associated with ARN), and 24 (0.6%) were due to TIN. We also compared these results with those reported in VigiAccess for other DOACs and vitamin K antagonists. This analysis suggests that the frequency of renal adverse events associated with rivaroxaban and other DOACs may be appreciably higher than what one might currently consider based only on the small number of fully published cases.
机译:直接口服抗凝血剂(DOAC)是最常见的药物中,DoAC相关的肾功能障碍可能是临床医生令人未知的问题。我们报告了一个82岁患者的案件,患者在罗西昔帕班的处方于心房颤动后两周内,为药物诱导的过敏综合征住院,其主要临床表现为低于患者的患者腿和急性肾功能衰竭(ARF)。在Rivaroxaban戒断后一周内,患者的临床状况改善和肾功能标准化。在对文献的审查中,我们只发现了五个案例报告的罗马洛巴班相关的ARF:两名患者患有无纺育肾炎(锡),两种患有抗凝血相关的肾病(ARN),最后一个有Iga肾病。随着最近的一些出版物表明,由于抗凝药物引起的肾脏损伤可能主要是下降,我们还分析了VigiaceCess数据库的数据,世界卫生组织药物理解计划从全世界134名国家注册机构收集毒品相关不良事件。在PermiaceCess以来的所有rivaroxaban相关不良事件中,4,323(3.5%)是肾脏副作用,其中2,351(54.3%)由于未指明的ARF,363(8.4%)由于肾脏出血(特征相关)与ARN)和24(0.6%)锡。我们还将这些结果与VigiaCelcess的其他DoACs和维生素K拮抗剂进行了比较。该分析表明,与Rivaroxaban和其他DoAC相关的肾不利事件的频率可能会明显高于目前仅基于少量完全发布的案例所考虑的DOAC。

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