Xigduo XR and other diabetes medications may lead to a flesh eating bacterial infection of the genitals known as Fournier’s gangrene.

The U.S. Food and Drug Administration (FDA) recently warned that there may be serious dangers associated with a class of diabetes medications known as SGLT2 inhibitors. A variety of drugs are in this class including Invokana, Invokamet, Invokamet XR, Farxiga, Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Synjardy XR, Steglatro, Segluromet, and Steglujan.

These drugs work to prevent high blood sugar levels by processing excess sugar out of the body through the kidneys. In August 2018, the FDA warned that these medications may increase the risk for a genital flesh eating bacteria infection known as Fournier’s gangrene.

The bacteria which causes the condition typically enters the body through a cut in the skin, from which it can spread very quickly. Fournier’s gangrene affects the perineum and damages the muscles, nerves, fat, and blood vessels in the area. Outside of more recent cases associated with SGLT2 inhibitors, Fournier’s gangrene most commonly occurs in men.

SGLT2 Drugs and Fournier’s Gangrene

“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,” the federal agency said in a statement.

“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.”  This is in addition to these drugs being tied to other complications like ketoacidosis and kidney damage.

Between March 2013 and May 2018, seven men and five women were hospitalized due to Fournier’s gangrene while being treated with SGLT2 inhibitors such as Xigduo XR. Each of the affected patients had to undergo surgery to treat the condition, while some of them required multiple disfiguring surgeries. One of the affected SGLT2 patients died from the condition; some developed complications, according to the FDA’s statement.

Although Fournier’s gangrene is more common in diabetes patients, in over 30 years there were only six cases of the condition in patients taking other diabetes drugs. Combined with the fact that the recent reports started in the same year that the first SGLT2 inhibitor was approved, the evidence pushed the FDA to warn the public about the link.

The federal agency encourages patients taking Xigduo XR and other SLGT2 inhibitors to monitor for signs of Fournier’s gangrene. Potential warning signs include tenderness, redness, or swelling of the genitals or perineum.

If patients treated with Xigduo XR experience these or other symptoms, such as a fever, the FDA says they should seek prompt medical attention. Catching the infection early can mean the difference between life and death.

For patients taking Xigduo XR or another SGLT2 inhibitor but not experiencing symptoms, the FDA urges them to not stop treatment with the drug unless advised by a medical professional. Although Fournier’s gangrene is a frightening condition, untreated diabetes can be life threatening. Therefore, all medication changes should be discussed with a doctor.

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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