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[Posted 08/26/2020]
Invokana, Invokamet, Invokamet XR (canagliflozin): MedWatch Safety Alert - Boxed Warning about Risk of Leg and Foot Amputations Removed
AUDIENCE: Patient, Health Professional, Endocrinology, Pharmacy
ISSUE: Based on FDA's review of new data from three clinical trials, the boxed warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) prescribing information was removed.
FDA reviews of new clinical trial data demonstrated additional heart- and kidney-related benefits, which led to additional approved uses. Specifically, in 2018, canagliflozin was approved to reduce the risk of major heart-related events such as heart attack, stroke, or death in patients with type 2 diabetes who have known heart disease; and, in 2019, it was approved to reduce the risk of end-stage kidney disease, worsening of kidney function, heart-related death, and being hospitalized for heart failure in certain patients with type 2 diabetes and diabetic kidney disease.
Collectively, these newly identified effects of canagliflozin on heart and kidney disease show significantly enhanced benefit of this medicine. Safety information from recent clinical trials also suggests that the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored. Based upon these considerations, FDA concluded that the boxed warning should be removed.
BACKGROUND: Canagliflozin belongs to a class of medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.
RECOMMENDATION: Health care professionals and patients should continue to recognize the importance of preventative foot care and monitor for new pain, tenderness, sores, ulcers, and infections in the legs and feet. Risk factors that may predispose patients to the need for amputation should be considered when choosing antidiabetic medicines.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://reurl.cc/Z7Vg8V
Canagliflozin屬於第2型鈉-葡萄糖共同轉運蛋白（sodium-glucose cotransporter-2, SGLT2）抑制劑，其降低血糖的機轉，主要是增加體內糖分經由腎臟尿液的排泄量。根據美國FDA回顧三個臨床試驗的最新結果，建議刪除有關canagliflozin（Invokana，Invokamet，Invokamet XR）仿單中有關截肢風險的加框警語。
美國FDA檢視新的臨床試驗數據，顯示此藥對心臟和腎臟相關的其他益處，因而核可其他適應症用途。2018年canagliflozin已核准用於第2型糖尿病合併心臟疾病之病人，以降低重大心臟相關事件的風險，例如心臟病發作、中風或死亡；2019年canagliflozin再核准用於第2型糖尿病合併糖尿病腎病變患者，以降低末期腎臟疾病、腎功能惡化、心臟相關的死亡及因心衰竭住院的風險。
整體來說，canagliflozin新確認對心臟和腎臟疾病的效果，已增強使用此藥品的益處。近期臨床試驗的安全性結果亦顯示，儘管canagliflozin會增加截肢的風險，但其風險低於先前的報告，尤其是病人已進行適當監測時。基於這層考量，美國FDA建議應刪除加框警語。
醫療照護人員和病人應了解預防性足部護理的重要性，並監測腿部是否出現新的疼痛、壓痛、瘡、潰瘍和感染。選擇糖尿病藥物時，應考慮可能增加病人截肢的危險因子是否存在。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/Z7Vg8V
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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