Invokana and similar diabetes drugs have been linked to an increased risk of developing a rare flesh-eating bacteria in the genital area, according to a recent FDA communication.

The Food and Drug Administration (FDA) circulated a new warning that SGLT2 inhibitors can increase the chances of a flesh-eating bacteria infection known as Fournier’s gangrene, a specific gangrene of the perineum, which is the area between the genitals and the rectum.

The potentially deadly infection is so rare that prior to 2013, only six cases were seen among patients over the course of 30 years.

The FDA says approximately 1.7 million patients received a prescription for an SGLT2 inhibitor in the U.S. in 2017. Invokana (canagliflozin) was the first SGLT2 inhibitor to be approved in the U.S. in March 2013. Other drugs in this class linked to an increased risk of developing the flesh-eating bacteria are

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

The FDA reports a spike in reported cases of Fournier’s gangrene since SGLT2 inhibitors entered the market. A total of 12 incidents of the serious flesh-eating bacteria infection were reported to the FDA between March 2013 and May 2018. The FDA fears there could be even more victims with unreported infections. The dozen reported cases included seven men and five women. All of the patients were hospitalized and had surgery.

According to the FDA, “Some patients required multiple disfiguring surgeries, some developed complications, and one patient died.”

Warning signs of Fournier’s gangrene can include tenderness, redness or swelling of the genitals or the perineum, a fever over 100.4 degrees Fahrenheit, and a general feeling of being ill. Symptoms can quickly worsen.

Fournier’s gangrene starts in the tissue under the skin that surrounds muscles, nerves, fat and blood vessels of the perineum, but dead or dying tissue is often found in the genitals and can spread to the thighs, stomach and chest. Surgery to remove dead tissue often leaves patients disfigured. The flesh-eating bacteria usually enters the body through a cut or break in the skin.

Treatment for the flesh-eating bacteria includes antibiotics and surgery to remove gangrenous tissue and to drain the infection. The patient’s use of an SGLT2 inhibitor is halted, and blood glucose levels are closely monitored to determine a different course of treatment to control blood sugar.

Rare Flesh-Eating Bacteria Latest SGLT2 Issue

SGLT2 inhibitors control blood sugar levels in patients with type-2 diabetes by redirecting excess sugar away from the blood stream. Instead of re-entering the blood, excess sugar (glucose) exits the body through the kidneys and out the urine

Previous FDA Drug Safety Communications have been issued over the last few years regarding SGLT2 inhibitors and increased risks of kidney problems, ketoacidosis, serious urinary tract infections and leg and foot amputations. Patients with diabetes already are a population known to have an increased risk of kidney problems and of circulatory issues that can result in serious infections and potential amputations.

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.

Learn More