The FDA is Warning of Occurrences of a Serious Infection of the Genital Area with the Use of SGLT2 Inhibitors for Treatment of Type 2 Diabetes.

FDA Warning:

The U.S. Food and Drug Administration (FDA) is warning that cases of a 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. The FDA is requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient.

What is Fournier’s Gangrene?

Fournier’s gangrene is a 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. Having diabetes is a risk factor for developing Fournier’s gangrene.

THIS IS CAN BE A SERIOUS INFECTION AND MAY LEAD TO DEATH!

Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.

What are SGLT2 Inhibitors?

SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. First approved in 2013, medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin (see FDA-Approved SGLT2 Inhibitors). In addition, empagliflozin is approved to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

List of FDA-Approved SGLT2 Inhibitors:

Brand Name / Active Ingredient

• Invokana^® / canagliflozin
• Invokamet^® / canagliflozin and metformin
• Invokamet XR^® / canagliflozin and metformin extended-release
• Farxiga^® / dapagliflozin
• Xigduo^® XR / dapagliflozin and metformin extended-release
• Qtern^® / dapagliflozin and saxagliptin
• Jardiance^® / empagliflozin
• Glyxambi^® / empagliflozin and linagliptin
• Synjardy^® / empagliflozin and metformin
• Synjardy XR^®/ empagliflozin and metformin extended-release
• Steglatro^® / ertugliflozin
• Segluromet^® / ertugliflozin and metformin
• Steglujan^® / ertugliflozin and sitagliptin

For a free case evaluation of your potential claim involving Fournier’s Gangrene and Type 2 Diabetes medications, contact The Buchanan Law Office, P.C. by completing the form on this page. The firm is handling Fournier’s Gangrene and SGLT2 Inhibitor lawsuits nationwide. For a consultation with a Fournier’s Gangrene Attorney, contact us now.

Contact Us Today!