Diabetes Drugs That Can Trigger Flesh-Eating Disease in the Genital Area

If you watch any TV you have probably seen commercials for type-2 diabetes drugs such as Jardiance (empagliflozin) and Farxiga (dapagliflozin). You have heard the refrain, right? “Jardiance is a little pill with a big story to tell…” Some of the Farxiga commercials just repeat the name [FAR-SEE-GUH] over and over without telling you what the drug is for. These drugs (and others such as Invokana, Synjardy and Steglatro) are called SGLT2 inhibitors. On August 29, 2018 the FDA warned about “serious infection of the genital area with SGLT2 inhibitors for diabetes.” The agency was referring to Fournier’s gangrene, a flesh-eating disease “between and around the anus and genitals.”

Do Doctors and Pharmacists Warn About Flesh-Eating Disease in the Perineum?

First, a lot of people are not familiar with the term perineum. If a television commercials warns about a “rare, life-threatening bacterial infection in the skin of the perineum,” many viewers may be unaware of that delicate location. And many healthcare professionals may not mention that the tissue between the genitals and anus is vulnerable to this complication.

This is a part of the human anatomy that most people would prefer not to think or talk about. But when certain diabetes drugs are prescribed, physicians and pharmacists must warn about potential infections in that area!

Reader Learns About Flesh-Eating Disease and Certain Diabetes Drugs:

The following question and answer ran in our nationally syndicated People’s Pharmacy newspaper column:

Q. My doctor urged me to take Jardiance for type 2 diabetes. When I did some research on this medication, I found that it could cause “necrotizing fasciitis of the perineum.” This is flesh-eating disease of the area from the vagina to the anus. The commercials I’ve seen lately mention this side effect in a less threatening way as an “irritation.” That’s so misleading!

Our response:

A. When we watched a current Jardiance commercial, we found this:

“Serious side effects include increased ketones in blood or urine and infection between and around the anus and genitals, both may be fatal, severe allergic reactions, dehydration, urinary tract or genital yeast infections in men and women and low blood sugar…”

“Tell your doctor about lightheadedness, weakness, fever, pain, tenderness, redness, or swelling between the anus and genitals. You may have increased risk for lower limb loss.”

That is certainly a sobering prospect, even if it is relatively rare. The FDA warns that this entire class of medications, SGLT2 inhibitors, can cause life-threatening complications.

The reader is right to be alarmed. This flesh-eating disease is life-threatening, and every patient prescribed these drugs deserves to understand the full picture. In theory, though, this is quite rare.

The FDA Warning About Flesh-Eating Disease and SGLT2 Inhibitors:

On August 29, 2018 the FDA issued a warning about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes:

“The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.”

Let’s be honest, the description “sodium-glucose cotransporter-2 (SGLT2) inhibitors” does not come trippingly to the tongue. Here are just a few of such drugs:

• Bexagliflozin (Brenzavvy)
• Canagliflozin (Invokana)
• Dapagliflozin  (Farxiga)
• Empagliflozin (Jardiance)
• Ertugliflozin (Steglatro)

In plain English, what the FDA is warning about is a flesh-eating disease that can develop in the tissue between the genitals and the anus in patients taking this class of diabetes drug. It can be fatal.

The pharmaceutical companies behind both Jardiance and Farxiga are big spenders when it comes to TV commercials. If you have somehow missed these ads, here are some links:

Farxiga for chronic kidney disease

Farxiga for type 2 diabetes

Jardiance for type 2 diabetes

Does the Jardiance jingle trigger your memory?

• “I have type 2 diabetes, but I manage it well.
• “It’s a little pill with a big story to tell…
• “Jardiance is really swell
• The little pill with a big story to tell”

The old jingle never mentioned the phrase “flesh-eating disease.” It did not use the term “Fournier’s gangrene.” There was nothing about “necrotizing fasciitis.”

The question we are left with: do people watching these commercials truly understand that a flesh-eating disease could develop between their genitals and their anus and that it could kill them? We have serious doubts.

What Exactly Is This Flesh-Eating Disease?

Fournier’s Gangrene Explained

The official medical name for this flesh-eating disease is Fournier’s gangrene. It is also called necrotizing fasciitis. Here is how the FDA describes it:

“Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. The bacteria usually get into the body through a cut or break in the skin, where they quickly spread and destroy the tissue they infect.”

Named after French dermatologist Dr. Alfred Fournier, who first described it in 1883, this flesh-eating disease is notable for how rapidly it progresses.

Here is how StatPearls describes it (Jan. 2024):

“Fournier gangrene, a relatively rare form of necrotizing fasciitis, is a rapidly progressive disease that affects the deep and superficial tissues of the perineal, anal, scrotal, and genital regions. Named after Dr. Alfred Fournier, the French dermatology and venereal specialist, it was initially described in 1883 as necrotizing fasciitis of the external genitalia, perineal, and perianal region in five of Dr. Fournier’s patients. Also known as necrotizing fasciitis, the disease involves the rapid spread of severe inflammatory and infectious processes along fascial planes affecting adjacent soft tissue; therefore, the disease may initially go unnoticed or unrecognized as there may be minimal or no skin manifestations in its early stages.”

The disease can initially go unnoticed because there may be minimal or no skin signs in its early stages — while destruction is already occurring beneath the surface.

The fatality rate for Fournier’s gangrene is reported at approximately 40%.

Other Names for This Flesh-Eating Disease

You may encounter this condition under several names in the medical literature:

• Necrotizing fasciitis
• Fournier’s gangrene
• Flesh-eating bacteria (or flesh-eating disease)
• Idiopathic gangrene of the scrotum
• Streptococcal scrotal gangrene
• Synergistic necrotising cellulitis
• Phagedena

How Many Cases of Flesh-Eating Disease Have Been Reported?

When the FDA issued its 2018 warning, it had identified only 12 confirmed cases of this flesh-eating disease linked to SGLT2 inhibitors. That has led many prescribers to dismiss the risk as vanishingly rare. But the FDA itself acknowledged that the true number of cases is almost certainly higher, because adverse drug reactions are notoriously underreported.

By June 2019, researchers reporting the Annals of Internal Medicine (June 4, 2019) had identified 55 unique cases of Fournier’s gangrene in patients taking SGLT2 inhibitors between March 2013 and January 2019. Among those patients:

• All required surgical removal of infected tissue
• Eight patients required fecal diversion surgery
• Nine developed sepsis or septic shock
• Four developed acute kidney injury
• Two required amputation of a lower extremity
• Three patients died

An article in Cureus, June, 2024 added further context: researchers believe the elevated sugar levels in the urine caused by SGLT2 inhibitors may create an environment that promotes the growth of the bacteria responsible for this flesh-eating disease, particularly in the urinary and genital regions.

Complete List of Diabetes Drugs Linked to Flesh-Eating Disease

In its 2018 warning, the FDA listed the following medications as containing an SGLT2 inhibitor:

Warning Signs of Flesh-Eating Disease: What the FDA Wants You to Know

The FDA is direct about what patients should watch for. Seek medical attention immediately if you experience:

• Tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum
• Fever above 100.4°F
• A general feeling of being unwell — especially in combination with any of the above

The FDA adds a critical caution: these symptoms can worsen extremely quickly. Do not wait to see if things improve on their own. This flesh-eating disease can become life-threatening in a matter of hours.

“Health care professionals should assess patients for Fournier’s gangrene if they present with the symptoms described above. If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.” — FDA

What Should You Do If You Take These Diabetes Drugs?

We do not want patients to panic, or to stop taking their medication without speaking to their doctor. SGLT2 inhibitors offer real benefits, and for many patients, those benefits outweigh the risks. But you deserve to make that decision with full information.

Here is what we recommend:

• Ask your doctor or pharmacist directly: “What are the signs of a serious skin infection I should watch for?”
• Know the location: the perineum is the area between your genitals and your anus.
• Do not dismiss early symptoms. Redness, swelling, or pain in that area, especially with fever, is a medical emergency.
• If you develop those symptoms, go to an emergency room immediately. Do not wait for a routine appointment.
• Report adverse reactions to the FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch.

There are many options for managing type 2 diabetes. We have discussed them in detail in our eGuide to Preventing and Treating Diabetes, available under the Health eGuides tab. If you know someone with diabetes you might want to pass this article along. Thank you for supporting our work.