FDA: Cases of Rare Gangrene of Genital Area Tied to Diabetes Drug Class

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The FDA is requiring a new warning be added to the prescribing information and patient Medication Guide of all SGLT2 inhibitors.
The FDA is requiring a new warning be added to the prescribing information and patient Medication Guide of all SGLT2 inhibitors.

The Food and Drug Administration (FDA) has issued a warning regarding rare cases of necrotizing fasciitis of the perineum associated with sodium-glucose cotransporter-2 (SGLT2) inhibitors, a class of drugs approved to treat type 2 diabetes.

Necrotizing fasciitis of the perineum, also known as Fournier's gangrene, is a serious infection of the genitals and area around the genitals. Over a 5-year period (March 2013 to May 2018), the FDA identified 12 cases (7 men and 5 women) of Fournier's gangrene in patients taking an SGLT2 inhibitor. The infection developed within several months of the patients starting SGLT2 therapy and the drug was discontinued in most cases. All patients required surgery and there was 1 reported death.

SGLT2 inhibitors are currently approved as adjunct to diet and exercise to lower blood glucose in adults with type 2 diabetes. They work by causing the kidneys to remove sugar from the body through the urine. Approved drugs in the SGLT2 inhibitor class include: 

  • canagliflozin (Invokana)
  • canagliflozin and metformin (Invokamet, Invokamet XR)
  • dapagliflozin (Farxiga)
  • dapagliflozin and metformin extended-release (Xigduo XR)
  • dapagliflozin and saxagliptin (Qtern)
  • empagliflozin (Jardiance)
  • empagliflozin and linagliptin (Glyxambi)
  • empagliflozin and metformin (Synjardy, Synjardy XR)
  • ertugliflozin (Steglatro)
  • ertugliflozin and metformin (Segluromet)
  • ertugliflozin and sitagliptin (Steglujan)

As a result, the FDA is requiring a new warning be added to the prescribing information and patient Medication Guide of all SGLT2 inhibitors. Healthcare professionals should assess patients for Fournier's gangrene if they present with symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4ºF, or feel general malaise. 

Treatment should be initiated immediately with broad-spectrum antibiotics and surgical debridement if needed. The SGLT2 inhibitor should be discontinued and the patient's glucose levels should be closely monitored; alternative treatment for glycemic control should be considered.

For more information visit FDA.gov.

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