The FDA says a rare flesh-eating infection that attacks the genital region has been identified in 12 patients taking diabetes medications known as SGLT2 inhibitors.

The flesh-eating infection that has been reported by the U.S. Food and Drug Administration resulted in the hospitalization of all 12 and death of one identified patient.

The class of drugs linked to the flesh-eating infection were approved by the drug regulatory agency starting in 2013. They include medications sold under the following brand names:

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

SGLT2 inhibitors act to lower blood sugar in type-2 diabetes patients by inhibiting the process in the kidneys where excess sugars are reabsorbed into the bloodstream. Instead of re-absorption, the extra glucose is eliminated from the body via the kidneys and urine output.

The rare but serious flesh-eating infection is known as Fournier’s gangrene. Fournier’s gangrene tends to attack the tender tissue of the testicular, penis, and perineal area. On average, it is seven times more common in men than women, and the most vulnerable age group is between 50 and 60 years of age.

The bacteria that appears to cause the flesh-eating infection is believed to enter through a small break in the skin, according to a Daily Mail article. It can spread throughout an area very quickly, and the perineal area is particularly vulnerable.

This flesh-eating infection can be stopped in its tracks if it found and treated early. Treatment typically requires the removal of layers of infected tissue. This necessity can lead to dangerous complications, from which there is an average fatality rate of 30 percent.

In 2009, it was reported in a professional urology journal that Fournier’s gangrene was so rare as to only occur in 1.6 out of 100,000 males in the U.S. This statistic, however, was arrived at prior to the introduction of SGLT2 inhibitors, so it is unknown how much of an effect these medications have had on the rate of incidence.

Without this medication consideration, it was known that immune systems compromised through liver impairment, excess weight, and diabetes were big contributing factors in its development.

The Cases

The 12 reported cases of Fournier’s gangrene were divided among five women and seven men and were reported to the FDA between the springs of 2013 and 2018. Five of the identified patients required multiple surgical interventions, and one patient needed skin grafting to repair the damage caused from the flesh-eating infection.

The surgeries needed in some situations were very disfiguring and will probably be followed by some reconstruction. Although the locations of the reported patients were not publicized, the ages involved ranges from 38 to 78, according to the Daily Mail.

FDA Intervention

While the FDA has made it clear that this situation is rare, it cautions patients taking this class of drugs to be on the look out for swelling and redness in this area accompanied with a fever. Patients should also know that if there is decaying tissue, there might be an odd smell emanating from the area. The FDA will now require that a warning be added to the patient Medication Guide and drug labeling.

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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