Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death
AUDIENCE: Rheumatology, Internal Medicine, Patient
ISSUE: FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when the medicine was approved in 2009. Once the final results from the manufacturer are received, FDA will conduct a comprehensive review and will update the public with any new information.
The febuxostat drug labels already carry a Warning and Precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with febuxostat compared to allopurinol. These problems included heart attacks, strokes, and heart-related deaths. As a result, FDA required an additional safety clinical trial after the drug was approved and on the market to better understand these differences, and that trial was finished recently.
The safety trial was conducted in over 6,000 patients with gout treated with either febuxostat or allopurinol. The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery. The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol. However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.
BACKGROUND: Febuxostat is FDA-approved 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. Febuxostat works by lowering uric acid levels in the blood.
RECOMMENDATION: Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
痛風可能發生於尿酸累積，造成一個或多個關節的紅、腫、痛，febuxostat可降低血中尿酸的量，因此美國FDA許可用於治療成人痛風。Febuxostat因上市前的臨床試驗發現與allopurinol相較，有較高比例出現心臟相關副作用，包含心臟病發(heart attacks)、中風(strokes)以及心臟相關的死亡(heart-related deaths)，因此已於仿單加註關於心血管相關風險的警語，並且美國FDA要求廠商於2009年此藥上市時需執行額外的安全性相關臨床試驗，目前此試驗即將結束。
此安全性相關之臨床試驗納入超過6000位使用febuxostat或allopurinol之痛風病人，分析其心血管相關風險(複合終點：合併心臟相關的死亡(heart-related death)、非致命的心臟病發(non-deadly heart attack)、非致命的中風(non-deadly stroke)以及血流供應至心臟不足而需要緊急手術(a condition of inadequate blood supply to the heart requiring urgent surgery)。其期中分析之結果顯示整體而言，febuxostat與allopurinol相較並未增加複合終點(合併心臟相關的死亡、非致命的心臟病發、非致命的中風以及因血流供應至心臟不足而需要緊急手術)之風險；然而當分開分析心血管相關事件，febuxostat與allopurinol相較，可能會增加心臟相關死亡以及整體死亡率(death from all causes)之風險。