Uloric (febuxostat): Boxed Warning Added - Due to Increased Risk of Death with Gout Medicine
AUDIENCE: Health Professional, Patient, Pharmacy
ISSUE: FDA has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.
BACKGROUND: Uloric was FDA-approved in 2009 to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Uloric works by lowering uric acid levels in the blood. Gout is a chronic disease that affects approximately 8.3 million adults in the U.S. The number of medicines to treat gout is limited and there is an unmet need for treatments for this disease.
RECOMMENDATION:
Patients should tell your health care professional if you have a history of heart problems or stroke and discuss the benefits and risks of using Uloric to treat your gout. Do not stop taking Uloric without first talking to your health care professional, as doing so can worsen your gout. Seek emergency medical attention right away if you experience the following symptoms while taking Uloric:
．Chest pain
．Shortness of breath
．Rapid or irregular heartbeat
．Numbness or weakness on one side of your body
．Dizziness
．Trouble talking
．Sudden severe headache
Health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol. Counsel patients about the cardiovascular risk with Uloric and advise them to seek medical attention immediately if they experience the symptoms listed above.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Drugs/DrugSafety/ucm631182.htm
Uloric（febuxostat）於2009年經美國FDA核准後上市，用於治療成人痛風。痛風的發生主要是體內尿酸積聚，導致一個或多個關節突然發紅、腫脹和疼痛。Uloric透過降低血液中的尿酸而達到治療痛風的作用。痛風是一種慢性病，影響美國大約830萬成年人，而目前能夠治療痛風的藥物有限。美國FDA發布相關藥物安全警訊：與另一種痛風藥物allopurinol相比，使用Uloric會增加死亡之風險。此結論是基於美國FDA針對一安全性相關之臨床試驗結果，深入回顧後發現Uloric會增加與心臟相關的死亡以及任何原因的死亡之風險。
如果病人有心臟病或中風病史，應告訴醫療專業人員，以確認使用Uloric治療痛風的益處和風險。在與醫療專業人員確認前，不要自行停止服用Uloric，以免痛風惡化。如果在服用Uloric時出現以下症狀，請立即尋求醫療協助：
．胸痛
．呼吸急促
．心跳快速或不規則心跳
．身體單邊麻木或無力
．頭暈
．說話困難
．突發劇烈頭痛
醫療專業人員開立Uloric，應僅用於失敗或不耐受allopurinol的病人。需提醒使用Uloric病人有關的心血管風險，並建議若遇到上述症狀時應立即就醫。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Drugs/DrugSafety/ucm631182.htm
[Posted 2/21/2019]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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