美国FDA就与安进罕见病药物有关的肝损伤病例发出警告

格隆汇04-01

美国食品药品监督管理局(FDA)表示，已发现服用安进公司用于治疗一组罕见自身免疫性疾病的药物的患者出现肝损伤病例，并敦促医疗机构一旦怀疑肝脏受损，应立即停止治疗。FDA已确认76例药物性肝损伤病例，有证据表明与Tavneos存在因果关系，其中包括7例胆管缺失综合征(VBDS)病例和8例死亡。此次安全警告加剧了监管机构对Tavneos的审查。FDA此前曾要求安进自愿撤回Tavneos，而安进公司拒绝...

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