FDA Raises Kidney Injury Warnings for Some Diabetes Medications

The U.S. Food and Drug Administration (FDA) reported a new requirement strengthening the current warning about the dangers of acute kidney injury involving certain diabetes medications. Drugs containing canagliflozin, (with trade names Invokana and Invokamet) and dapagliflozin (brand names Farxiga and Xigkuo XR) have received modification in the drug labeling informing consumers of acute kidney injury risks as well as recommendations to minimize this risk.

Canagliflozin and dapagliflozin are sodium-glucose co-transporter 2 (SGLT2) inhibitors that along with diet and exercise help lower blood glucose in adults with type 2 diabetes. These medications decrease blood glucose by causing the kidneys to remove sugar from the body through the urine.

Canagliflozin was approved in March 2013. Through October 2015, the FDA has received 101 reports of cases of acute kidney injury. Of those cases, 73 were related to canagliflozin, and 28 with canagliflozin or dapagliflozin use. Hospitalization was necessary for 96 cases, 22 of which were admitted to the intensive care unit. There were 4 deaths reported during hospitalization.

Dialysis was given to 15 patients, 3 of whom had a history of chronic kidney disease or previous acute kidney issues. Approximately half of the reported cases of acute kidney injury occurred within 1 month of starting the drug. Most patients improved upon discontinuing the medication.

Healthcare providers are advised to consider factors that may predispose patients to acute kidney injury prior to administering canagliflozin or dapagliflozin. Risk factors include decreased blood volume, chronic kidney insufficiency, congestive heart failure. Care is to be taken with additional drugs used by patients, such as diuretics, ACE inhibitors, ARBs, and NSAIDs.

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