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FDA issues warning label update for diabetes drug; cites risk for infections

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The FDA has called for additional warning labels on type 2 diabetes medications that contain sodium-glucose cotransporter-2 inhibitors after a safety review found the medications were associated with an excess risk for blood and urinary tract infections, according to a press release.

An alert was previously issued by the FDA in May about the risk for ketoacidosis in patients who consumed sodium-glucose cotransporter-2 (SGLT2) inhibitors, including Invokana (canagliflozin, Janssen Pharmaceuticals), Farxiga (dapagliflozin, AstraZeneca AB) and Jardiance (empagliflozin, Boehringer Ingelheim). The medications are FDA approved for use with diet and exercise to reduce blood sugar in adults with type 2 diabetes.

FDA investigators identified 73 cases of ketoacidosis between March 2013 and May 2015 among patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors. In addition, the agency was notified of 19 cases of UTIs that escalated to life-threatening blood and kidney infections from March 2013 to October 2014. All cases were hospitalized, and several were admitted to an ICU or treated with dialysis for kidney failure.

The new warning labels of all SGLT2 inhibitors address these safety issues and provide prescription and surveillance recommendations, the release said. Manufacturers of SGLT2 inhibitors are required to conduct a postmarketing study and report cases of ketoacidosis in patients who receive the medication. They also must follow patients for 5 years to collect additional data.

The FDA recommends that health care professionals assess ketoacidosis and UTIs in patients who present with nausea, vomiting, abdominal pain, tiredness and trouble breathing after taking SGLT2 inhibitors. They also advise patients to stop taking SGLT2 inhibitors if they experience symptoms of ketoacidosis or UTI. The incidence of ketoacidosis can occur with SGLT2 inhibitors even if blood sugar levels are “not very high,” the release said.

Adverse events related to the use of SGLT2 inhibitors should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.