FDA Increases Kidney Warnings in “Drug Safety Communication for Type 2 Diabetes Medicines Invokana, Invokamet, Farxiga, and Xigduo XR

The U.S. Food and Drug Administration (FDA) recently strengthened the existing warning about the risk of acute kidney injury for the Type 2 diabetes medicines Invokana and Invokamet (canagliflozin) and Farxiga and Xigduo XR (dapagliflozin ). Based on recent reports, the agency revised the warnings on the drug labels for these medications to include information about acute kidney injury and also added recommendations to minimize this risk.

Invokana, Invokamet, Farxiga, and Xigduo XR are prescription medicines used in collaboration with diet and exercise to help lower blood sugar levels in adults diagnosed with Type 2 diabetes. The drugs are in the class of medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, which lower blood sugar by causing the kidneys to release sugar from the body through the urine. Untreated, Type 2 diabetes may lead to serious health problems, including blindness, nerve and kidney damage, and heart disease.

Patients experiencing signs and symptoms of acute kidney injury—decreased urine output and increased leg and foot swelling—should immediately seek medical attention and should not stop taking their medication unless advised to do so by their physicians. Acute kidney injury is a serious condition in which the kidneys suddenly cease working, which leads to dangerous levels of wastes building up in the body; however, abruptly stopping prescribed medication may lead to sometimes dangerous, uncontrolled blood sugar levels.

Federal regulators note that health care professionals should consider any influences that may incline patients diagnosed with Type 2 diabetes to acute kidney injury before those patients are treated with Invokana, Invokamet, Farxiga, or Xigduo XR. Factors include decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and nonsteroidal anti-inflammatory drugs (NSAIDs). Kidney function should also be assessed before starting these drugs and patients should be routinely monitored while taking these drugs. Should acute kidney injury occur, the FDA advises physicians to promptly discontinue the medication and treat the kidney issues.

Since Invokana, Invokamet, Farxiga, and Xigduo XR were approved in March 2013 and to October 2015, the FDA has received reports of 101 confirmable cases of acute kidney injury that, in some cases, involved hospitalization and dialysis treatment, with these drugs. Since this number includes just those reports submitted to the FDA Adverse Event Reporting System (FAERS), it is likely that additional cases occurred that have not been reported to the agency.

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