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FDA Warns SGLT2 Inhibitors Could Lead to Fournier’s Gangrene

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The U.S. Food and Drug Administration (FDA) recently warned consumers that a class of type 2 diabetes medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors has been linked to a rare but serious infection of the genitals and the genital area called necrotizing fasciitis of the perineum (Fournier’s Gangrene).

The FDA approved SGLT2 inhibitors in 2013 to help to lower a person’s blood sugar by causing the kidneys to excrete it from the body through the urine. Medications in the SGLT2 class include Invokana (canagliflozin), Farxiga (dapagliflozin), Jardiance (empagliflozin), and Steglatro (ertugliflozin).

What is Fournier’s Gangrene?

Fournier’s Gangrene is a very rare but life-threatening bacterial infection affecting the tissue beneath the skin surrounding the muscles, nerves, fat, and blood vessels of the perineum. In men, this is the area between the scrotum and the anus; in women, this is the area between the anus and the vulva. The bacteria typically get into the body through a cut or some type of break in the skin.

The types of infections that lead to Fournier’s gangrene include:

Fournier’s Gangrene is characterized by scrotum pain and redness that progresses rapidly to gangrene and sloughing of the tissue. The condition can rapidly spread from the genitals to the thighs, stomach, and chest.


Patients should seek medical attention immediately if you experience any symptoms … and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.

FDA.gov

The FDA identified 12 instances of Fournier’s Gangrene among patients who had been prescribed an SGLT2 inhibitor from March 2013 to May 2018. There may be more cases that the agency is not aware of. All these patients were hospitalized and required surgery (some multiple surgeries), and one person died as a result. Fournier’s gangrene developed within several months of the patients starting an SGLT2 inhibitor. While being diabetic is a risk factor for the development of Fournier’s Gangrene, the condition is still considered uncommon with diabetic patients.

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