FDA 在痛風藥物 Uloric 的說明書中添加黑框警告，強調服用該藥會增加心臟相關性死亡和全因死亡的風險，並限制已獲批的 Uloric 的使用，僅限於那些不能接受痛風藥物 Allopolinol 的患者。
The FDA has added Boxed Warning to the label of gout medicine Uloric that highlights the increased risk of death with the drug.
FDA 在痛風藥物 Uloric 的標籤中添加了 Boxe 警告，強調該藥增加了死亡風險。
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.
在對一項安全臨床試驗的結果進行深入審查後， FDA 發現與心臟相關的死亡和死亡風險增加的所有原因與 Uloric有關 。除了添加 Boxe 警告之外， FDA 還限制已經批准的 Uloric 的使用，僅限於那些不能容忍另一種痛風藥物 Allopolinol 的患者。
Uloric, indicated for the chronic management of hyperuricemia in patients with gout, and developed by Takeda, was approved by the FDA in 2009.
Uloric ，用於痛風患者高尿酸血癥的慢性管理，由武田（Takeda）開發，於2009年獲得 FDA 批准。
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".
FDA 授權的上市後研究結果於2018年3月發表在《新英格蘭醫學雜誌》網絡版上。結果顯示，在同時患有心血管疾病的痛風患者中，與別嘌醇治療相關的主要心血管事件發生率相似。然而，在 Uloric 組和Allopolinol 組對比中，前者更易導致心血管死亡和全因死亡。
閱讀更多 匯眾醫療 的文章
