The FDA recently warned the public that a class of diabetes drugs known as SGLT2 inhibitors could cause some patients to develop Fournier’s disease, a flesh-eating infection that attacks the genitals and surrounding area.

While this condition is much more common in men than women, all patients on SGLT2 inhibitor medications should be wary for signs of Fournier’s disease.

The FDA issued this warning after Fournier’s disease was linked to one fatality and 11 other serious injury cases, in which patients were left with mutilated genitals and were hospitalized. The FDA announced in August 2018 that Invokana side effects and those of other SGLT2 inhibitors may be linked to Fournier’s disease, requiring manufacturers to add the disease.

The FDA is now calling for Fournier’s disease to be included on the list of Invokana side effects and other SGLT2 inhibitor labels as well as the patient medication guide.

The FDA stated it had received reports of 12 cases of Fouriner’s disease from patients who were prescribed SGLT2 inhibitors for type-2 diabetes treatment purposes, with five women and seven men submitting the reports between March 2013 and May 2018.

The FDA further stated that one of the patients died, and all of them had to undergo surgery to remove dead tissue. Five of the patients reportedly required more than one surgery and one needed a skin grafting, with two of them transferred to a rehabilitation hospital.

Other patients required multiple reconstruction surgeries, and further fueled the concern of the FDA.

Overview of Fournier’s Disease

Fournier’s disease is a rare infection that most patients will not experience. When it does happen, bacteria enter the body through a cut or break in the skin and begins to attack the flesh near and behind the genitals.

Patients between the ages of 50 and 60 face an increased risk, with signs of symptoms including fever, pain, and swelling in the genital area. While Fournier’s disease can be detected quickly and treated, patients may need multiple surgeries to remove the infected tissue.

It is important to note that between 20 and 40 percent of patients die from this condition, so it is important for Fournier’s disease to be added to the warning labels of SGLT2 inhibitor drugs.

According to a 2009 study in the Journal of Urology, there are approximately 1.6 cases per 100,000 males in the United States and are most likely in patients with compromised immune systems including those who are suffering from type-2 diabetes. In 2017, it was estimated that 1.7 million people were prescribed SGLT2 inhibitors like Invokana.

Invokana and other SGLT2 inhibitors work by signaling the kidneys to remove excess sugar from the body through urination, and are supposed to be used in conjunction with diet and exercise.

While there are a number of serious Invokana side effects patients should be wary of, the recent association with Fournier’s disease only adds to the concern.

SGLT2 inhibitor patients who develop Fournier’s disease may be able to file legal action against manufacturers for allegedly failing to disclose this condition.

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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