藥物警訊

Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings

AUDIENCE: Endocrinology, Internal Medicine, Nephrology, Pharmacy

ISSUE: FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.

BACKGROUND: Canagliflozin and dapagliflozin are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes. They belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin and dapagliflozin lower blood sugar by causing the kidneys to remove sugar from the body through the urine.

From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases* of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use (see Drug Safety Communication for the Data Summary). This number includes only reports submitted to FDA, so there are likely additional cases about which we are unaware.

RECOMMENDATION: Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin. These include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs). Assess kidney function prior to starting canagliflozin or dapagliflozin and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.

Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet. Patients should not stop taking their medicine without first talking to their health care professionals. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Read the patient Medication Guide you receive with your canagliflozin or dapagliflozin prescriptions. It explains the benefits and risks associated with the medicine.

Read the MedWatch safety alert, including link to the Drug Safety Communication, at: 
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm

美國FDA發布藥品安全警訊，服用降血糖藥品SGLT2抑制劑canagliflozin和dapagliflozin可能增加急性腎衰竭之風險。美國FDA已將此訊息加註於藥品仿單中並增加相關建議事項。

經統計自2013年3月canagliflozin核准上市到2015年10月，確診為因服用canagliflozin或dapagliflozin發生急性腎衰竭通報美國FDA之案例報告共有101件，部分案例甚至需住院且接受透析治療。

美國FDA建議醫療人員在處方canagliflozin和dapagliflozin前，應先考量可能造成病人發生急性腎衰竭的因素，如血容量減少、慢性腎功能不全、充血性心衰竭和正在服用如利尿劑、降壓藥（angiotensin-converting enzyme (ACE) inhibitors、angiotensin receptor blockers (ARBs)和非類固醇消炎止痛藥(NSAIDs)）。開始使用canagliflozin和dapagliflozin前應評估病人腎功能，並定期追蹤。若病人發生急性腎衰竭，應立即停藥並治療。

美國FDA建議正在服用canagliflozin和dapagliflozin之病人若發現有疑似急性腎衰竭之症狀，如尿量減少、下肢水腫，應立即就醫。在尚未與醫療人員連絡前請勿自行停藥，以免導致血糖控制不當而造成傷害。

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm
[Posted 06/14/2016]

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