The incidence of a serious genital infection, the Fournier’s gangrene, has been noted to rise with the use of SGLT2 inhibitors. This has prompted the FDA to add an alert with its use.

SGLT2 inhibitors include dapagliflozin, canagliflozin, empagliflozin, and ertugliflozin. These drugs have recently been marketed for the treatment of type 2 diabetes patients.

Although these drugs have several advantages like reduction of blood pressure and have good cardiovascular outcomes, recurrent urinary tract infections and volume depletion are common adverse effects of these drugs.

Urinary tract infections, although can become problematic at times, but are not scary enough to influence the physicians to limit its use.

The recent warning by the FDA regarding the use of SGLT2 inhibitors and associated serious genital infection like necrotizing fasciitis of the perineum may become a barrier to its use since these infections can be life-threatening.


FDA issues warning with the use of SGLT2 inhibitors!

The FDA issued a warning alert with the use of these drugs after reports were received regarding the incidence of a severe genital infection. 12 cases of necrotizing fasciitis of the perineum also called Fournier’s gangrene in diabetic patients using SGLT2 inhibitors were identified over the past five years.

Necrotizing fasciitis of the perineum is rarely found in women but 5 of these 12 cases were women. All the 12 reported cases required hospitalization. Out of these, half required multiple surgeries.

Four patients developed complications like diabetic ketoacidosis, acute kidney injury, and septic shock. One out of the twelve patients died and two were shifted to the rehabilitation center.

Although diabetes itself is associated with severe skin and soft tissue infections, the drugs SGLT2 inhibitors have been specifically associated with the genital infection – the Fournier’s gangrene or necrotizing fasciitis.

Studies were reviewed and only 6 cases of Fournier’s gangrene were identified from 1984 to 2018. All of these 6 cases were male patients with diabetes.


What is Fournier’s gangrene or necrotizing fasciitis of the perineum?

Necrotizing fasciitis is basically the destruction of fascia and subcutaneous fats by invasive bacterial pathogens. It is usually divided into Type 1 and type 2 disease.

Type 1 necrotizing fasciitis is polymicrobial while type 2 is associated with streptococcal beta hemolytic infections.

Necrotizing fasciitis of the perineum or Fournier’s gangrene is especially more common in patients with Type 2 Diabetes Mellitus, intravenous drug users, obesity, patients with traumatic wounds, immunosuppression, and surgeries.

One out of every fourth patient with Fournier’s gangrene dies. So early recognition is critical as rapid progression and extensive destruction of the soft tissue and surrounding structures can occur.

genital infection
clinical features of Fournier’s gangrene – a serious genital infection

Symptoms of Fournier’s gangrene and why this is a serious genital infection

Symptoms of Fournier’s gangrene include redness, swelling, vesicles and bulla formation in the genital area.

Patients can develop signs of systemic toxicity including high-grade fever, low blood pressure, and acidosis. Absent pain sensation in the area precedes the bluish-blackish discoloration or gangrene formation.

Extensive necrosis of the skin occurs followed by involvement of the vessels and nerves. Thus, patients may lose their limbs, undergo orchiectomy (removal of the testis) and most importantly they may not survive.

genital infection
treatment of Fournier’s gangrene

Treatment of Fournier’s gangrene – a serious genital infection

Surgery and extensive debridement is the mainstay of treatment undercover of broad-spectrum antibiotics which should especially cover the anaerobic organisms.

These include imipenem and meropenem, piperacillin/tazobactam and clindamycin or metronidazole. Prognosis is relatively poor in these cases especially in elderly diabetic patients and patients with other systemic diseases like cirrhosis renal failure and heart failure.

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[…] Balanitis, pyelonephritis, tissue necrosis, urinary tract infection (UTI), vaginitis: Diabetic patients are at risk of developing genitourinary tract infections. The risk of these infections is increased several times with the use of empagliflozin and other SGLT2 inhibitors. Patients should be promptly evaluated for these infections if they develop fever, burning micturition, flank pain, urgency, and pyuria. Severe genital infections like Necrotizing fasciitis have been reported with its use including fatal… […]

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[…] Recurrent urinary tract infections, and urogenital infections including severe tissue necrosis: Diabetic patients are prone to develop genitourinary tract infections. The risk of these infections is increased several times with the use of empagliflozin and other SGLT2 inhibitors. Patients should be evaluated for these infections if they develop flank pain, fever, burning micturition, urgency, and pyuria. Severe genital infections like Necrotizing fasciitis have been reported with its use including fatal… […]

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[…] increases the risk of urinary tract and genital infections and […]

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[…] necrosis and Necrotizing fasciitis, […]

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[…] SGLT2 inhibitors have been associated with an increased incidence of necrotizing fasciitis of the perineum (Fournier gangrene). […]