Qtern and other type-2 diabetes medications have been linked to Fournier’s gangrene, a “flesh eating bacteria” affecting the genital area.

In August 2018, the U.S. Food and Drug Administration (FDA) recently warned patients that Fournier’s gangrene has been reported in patients taking a certain type of diabetes medication known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.

The FDA has required new warnings for Fournier’s gangrene to be added to SGLT2 inhibitor labeling so that the public is more informed.

SLGT2 inhibitors include: canagliflozin (sold under brand names Invokana, Invokamet, and Invokamet XR), dapagliflozin (sold under brand names Farxiga, Xigduo XR, and Qtern), empagliflozin (sold under brand names Jardiance, Glyxambi, Synjardy, and Synjardy XR), and ertugliflozin (sold under brand names Steglatro, Segluromet, and Steglujan).

Fournier’s gangrene, also known as necrotizing fasciitis or “flesh eating bacteria”, is a bacterial infection which attacks the muscles, nerves, fat, and blood vessels of the genital area. The condition is extremely rare and is estimated to affect around 1.6 of 100,000 men every year, mostly between the ages of 50 to 79. The bacteria which causes the condition enters the body through a cut in the skin. After it enters the body, the bacteria can spread very quickly and destroy massive amounts of tissue.

However, Fournier’s gangrene has been reported in patients taking SGLT2 inhibitors such as Qtern to manage their type-2 diabetes. Between March 2013 to May 2018, the FDA received reports of 12 cases of Fournier’s gangrene. Of the 12 cases, seven were men but five were women. Outside of these reports, Fournier’s gangrene is rarely reported in women.

For reference, only six cases of Fournier’s gangrene were reported between 1984 and 2018, all of which affected men.

The patients involved in the reports developed Fournier’s gangrene an average of 9.2 months after starting Qtern or another SGLT2 inhibitor, but development time varied from 7 days to 25 months.

All of the patients were hospitalized and required surgery to remove the tissue affected by their Fournier’s gangrene. Five of the patients required additional surgery and one patient required skin grafts.

However, more serious complications did occur. Four patients developed complications including diabetic ketoacidosis, acute kidney injury, and septic shock. Two patients were transferred to a rehabilitation hospital, and one patient died.

SGLT2 inhibitors are commonly prescribed to treat type 2 diabetes, with 1.7 million patients filling prescriptions for the drugs in 2017. Patients on Qtern or another SGLT2 inhibitor should be vigilant for any signs of Fournier’s gangrene while on the medications. Warning signs may include tenderness, redness, or swelling of the genitals and a temperature higher than 100.4 F.

Fournier’s gangrene can quickly develop and worsen with extreme damage to genital tissue, so medical attention should be sought right away if a patient suspects they may have the condition. Fournier’s gangrene can be treated with antibiotics, but surgery may be necessary depending on the extent of tissue damage.

Join a Free Diabetes Medications & Flesh-Eating Infection Lawsuit Investigation

The type-2 diabetes medications linked to the flesh-eating infection include:

• Invokana
• Invokamet/Invokamet XR
• Farxiga
• Xigduo XR
• Qtern
• Jardiance
• Glyxambi
• Synjardy/Synjardy XR
• Steglato
• Segluromet
• Steglujan

If you or a loved one took one of the type-2 diabetes medications listed above and suffered from a flesh-eating genital infection, you may qualify to join this diabetes medication lawsuit investigation. Fill out the FREE form on this page for more information.

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