Canagliflozin (Invokana and Invokamet) and Dapagliflozin (Farxiga and Xigduo XR) - Increased Warnings Regarding Risk of Acute Kidney Injury
June 16, 2016
FDA received 101 reports of acute kidney injury associated with canagliflozin (73 patients) or dapagliflozin (28 patients) from March 2013 to October 2015. Most patients required hospitalization and some required dialysis or treatment in an intensive care unit. Over half of the patients developed acute kidney injury within 1 month of starting treatment with canagliflozin or dapagliflozin. Acute kidney injury resolved in the majority of patients following discontinuation of canagliflozin or dapagliflozin. However, some patients did not experience complete resolution. Four patients died despite drug discontinuation. FDA updated canagliflozin and dapagliflozin product labels to include details regarding the risk of acute kidney injury, patient risk factors, and management recommendations.
Canagliflozin and dapagliflozin are sodium-glucose cotransporter 2 (SGLT2) inhibitors used to treat type 2 diabetes in adults. They are available as single agents (Invokana, Farxiga) and in combination with metformin (Invokamet, Xigduo XR). Health care professionals should follow the current prescribing information for canagliflozin and dapagliflozin, and monitor patients for acute kidney injury risk factors such as hypovolemia, known renal impairment, heart failure, or use of other medications that can affect renal function (eg, diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, nonsteroidal anti-inflammatory drugs). Monitor renal function prior to starting SGLT2 inhibitors and throughout treatment. Patients should not stop taking canagliflozin or dapagliflozin without discussing the decision with their health care professional because uncontrolled blood sugar levels can cause serious health problems. Advise patients with an acute illness resulting in decreased food or fluid intake or severe vomiting or diarrhea to discuss temporarily stopping cangliflozin or dapagliflozin with their health care provider. Advise patients to contact their health care professional if they experience swelling in the lower limbs or decreased urine output.
More information is available at the following links:
- FDA MedWatch Alert:
- FDA Drug Safety Communication:
June 16, 2016;University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.