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FDA Warns SGLT2 Inhibitors Linked to Fournier's Gangrene Outbreak


In late August, the U.S. Food and Drug Administration (FDA) issued a warning after 12 cases of Fournier’s gangrene linked to FDA-approved sodium-glucose cotransporter-2 (SGLT2) inhibitors, which is a class of type 2 diabetes medicines.

Fournier’s gangrene is a rare but serious—potentially fatal—bacterial infection of tissue underneath the skin surrounding muscles, fat, nerves, and blood vessels of the perineum, which is the area of the body between the anus and the scrotum or vulva.

In combination with diet and exercise, SGLT2 inhibitors lower blood sugar in adults diagnosed with type 2 diabetes, prompting the kidneys to eliminate sugar in the body through urination. Initially approved five years ago, medicines in these inhibitors include empagliflozin, ertugliflozin, dapagliflozin, and canagliflozin.

Patients should seek immediate medical treatment if they experience the following symptoms:

  • Swelling of the genitals
  • Swelling of the area between genitals and back of the rectum
  • Redness
  • Tenderness
  • 100.4 F or above fever
  • The general feeling of being unwell

The bacteria from Fournier’s disease enters the body through either a break or cut in the skin. Then, the bacteria rapidly spreads and destroys the tissues they infect. While this condition is considered rare among adults with diabetes, having diabetes is certainly a risk factor.

The 12 cases included seven men and five women, who were hospitalized and needed surgery. Several patients required multiple disfiguring surgeries, some experienced complications, and one patient passed away.

An estimated 1.7 million patients received an SGLT2 inhibitor prescription in 2017.

SGLT2 Inhibitors approved by the FDA include:

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

If you live in Kansas City have contracted Fournier’s gangrene through the use of FDA-approved SGLT2 inhibitors, our experienced legal team at Bertram & Graf, L.L.C. can help you file a product liability claim to obtain financial compensation which covers medical expenses, lost wages, and pain and suffering. For more information, contact us and schedule a free consultation today.