FDA issues safety warning on SGLT2 inhibitors for diabetes

The US Food and Drug Administration yesterday warned that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors.

This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. The FDA is requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine, and were first approved in 2013, with others in as recently as 2017.

The FDA warned that SGLT2 inhibitors, which include AstraZeneca's Farxiga (dapagliflozin), Eli Lilly's Jardiance (empagliflozin), Johnson & Johnson’s Invokana(canagliflozin) and Merck & Co’s Steglatro (ertugliflozin), have been linked with cases of necrotising fasciitis of the perineum, also referred to as Fournier's gangrene. The agency said that it is requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors.