The FDA has added Boxed Warning to the label of gout medicine Uloric that highlights the increased risk of death with the drug.
Following an in-depth review of results from a safety clinical trial, the FDA has found that there is an increased risk of heart-related death and death from all causes with Uloric. Besides adding the Boxed Warning, the FDA is limiting the approved use of Uloric only to patients who have failed or do not tolerate another gout medicine Allopurinol.
Uloric, indicated for the chronic management of hyperuricemia in patients with gout, and developed by Takeda, was approved by the FDA in 2009.
The results of the FDA-mandated postmarketing study, published in The New England Journal of Medicine online, in March 2018, revealed that the "treatment with Uloric resulted in overall rates of major cardiovascular events that were similar to those associated with Allopurinol treatment among patients with gout who had coexisting cardiovascular disease. However, cardiovascular death and deaths from any cause were more frequent in the Uloric group than in the Allopurinol group".
Last June, a citizen petition was filed with the FDA requesting the immediate withdrawal of Uloric from the market.
Uloric is expected to go generic in June 2019, according to reports.
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FDA 在痛风药物 Uloric 的标签中添加了 Boxe 警告，强调该药增加了死亡风险。
在对一项安全临床试验的结果进行深入审查后， FDA 发现与心脏相关的死亡和死亡风险增加的所有原因与 Uloric有关 。除了添加 Boxe 警告之外， FDA 还限制已经批准的 Uloric 的使用，仅限于那些不能容忍另一种痛风药物 Allopolinol 的患者。
Uloric ，用于痛风患者高尿酸血症的慢性管理，由武田（Takeda）开发，于2009年获得 FDA 批准。
FDA 授权的上市后研究结果于2018年3月发表在《新英格兰医学杂志》网络版上。结果显示，在同时患有心血管疾病的痛风患者中，与别嘌醇治疗相关的主要心血管事件发生率相似。然而，在 Uloric 组和Allopolinol 组对比中，前者更易导致心血管死亡和全因死亡。
去年6月，美国食品和药物管理局（ FDA ）提交了一份公民请愿，要求立即撤回 Uloric 的市场。
据报道， Uloric 有望在2019年6月上市。
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