FDA Warning: Life-Threatening Genital Gangrene Linked To Certain Type 2 Diabetes Drugs
The FDA has just issued a warning that a certain class of common type 2 diabetes drugs, sodium-glucose cotransporter-2 inhibitors (SGLT2), has been linked to a dozen new cases of a rare infection called necrotizing fasciitis of the perineum, or Fournier’s gangrene.
Fournier’s gangrene affects the tissue under the skin that surrounds the muscles, nerves, fat, and blood vessels under the perineum (area between the anus and the back of a person’s external genitalia). The bacteria enters through a cut or break in the skin and rapidly destroys the infected tissue. It’s an extremely rare infection, but having diabetes puts a person at greater risk for developing gangrene in the first place, partly because gangrene can develop when diabetic foot ulcers become inflected.
But the FDA’s warning was a specific response to the identification of 12 reported cases of Fournier’s gangrene in those taking an SGLT2 inhibitor between March 2013 and May 2018. Though Fournier’s gangrene generally occurs much more often in males, five of the 12 identified cases were women. The infection developed after seven days to 25 months of the patients starting to take SGLT2 inhibitors, and average onset time was about nine months.
All 12 cases required hospitalization and surgery, and one person has died as a result of the infection. Among those taking anti-diabetic drugs other than SGLT2 inhibitors, the FDA only identified six cases of Fournier’s gangrene over a more than 30-year period. All six of those cases were in men.
In response to the increased frequency of cases among those taking SGLT2 inhibitors, the FDA is requiring that new warnings be added to the prescribing information and to the patient medication guide for all SGLT2 drugs. Below is a list of the current FDA-approved SGLT2 inhibitors:
Brand Name / Active Ingredient
Inokana / canagliflozin
Invokamet / canagliflozin and metformin
Invokamet XR / canagliflozin and metformin extended-release
Farxiga / dapagliflozin
Xigduo XR / dapagliflozin and metformin extended-release
Qtern / dapagliflozin and saxagliptin
Jardiance / empagliflozin
Glyxambi / empagliflozin and linagliptin
Synjardy / empagliflozin and metformin
Synjardy XR / empagliflozin and metformin extended-release
Steglatro / ertugliflozin
Segluromet / ertugliflozin and metformin
Steglujan / ertugliflozin and sitagliptin
What to do if you have concerns
The FDA is advising anyone experiencing symptoms of tenderness, redness, or swelling on or around the genitals or perineum, or a fever above 100.4 or general feeling of being unwell, to seek medical attention. While still rare, Fournier’s gangrene can escalate quickly and should be addressed immediately.
SGLT2 inhibitors can also cause yeast infections, which can cause limited genital itching, redness, and discharge. Unlike Fournier’s gangrene, yeast infections are not associated with a fever or feeling unwell.
Patients should talk to a medical professional about their concerns before changing their medications. Patients wishing to notify the FDA of an adverse event related to or believed to be related to a medication can report the incident to the FDA MedWatch program.