FDA strengthens kidney injury warnings on type 2 diabetes drugs

diabetes illus250x03 FDA strengthens kidney injury warnings on type 2 diabetes drugs Stronger warnings about acute kidney injury will be added to the safety labels of a class of type 2 diabetes treatments, which includes the prescription medications Invokana, Invokamet, Farxiga, and Xigduo XR, the Food and Drug Administration (FDA) announced in a Drug Safety communication.

The medications, which include the active drug ingredient canagliflozin or dapagliflozin, are prescription medicines that belong to a class of diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. They work by lowering blood sugar by causing the kidneys to remove the sugar from the body through the urine.

Since Invokana became the first drug in the class to be approved by the FDA in March 2013 through October 2015, the FDA has received 101 reports of confirmable cases of acute kidney injury, some of which required hospitalization and dialysis. “This number only includes reports were submitted to the FDA, so there are likely additional cases about which we are unaware,” the FDA said.

Health care professionals are advised to consider factors that may predispose patients to acute kidney injury prior to starting them on these medications, such as 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).

Kidney function should also be assessed prior to starting these medications. If acute kidney injury occurs, the FDA recommends that the medication be promptly discontinued and the kidney impairment treated.

“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,” the FDA said. “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.”

Since 2013, Invokana and other SGLT2 inhibitors have been linked to an increased risk of lower limb amputations, serious urinary tract infections, bone fractures, decreases in bone density, and ketoacidosis, a serious condition in which too much acid builds up in the blood.

Source: FDA