SGLT2 Gangrene Infection Risk in Diabetes Patients

Cincinnati Drug Injury Lawyer and Ohio Product Liability attorney reviews diabetes patients reporting SGLT2 gangrene infection and severe SGLT2 inhibitor complications

The U.S. Food and Drug Administration (FDA) recently warned that widely-used SGLT2 inhibitors—common diabetes drugs—may cause a serious genital infection called Fournier’s gangrene, a rare and life-threatening bacterial infection.

The FDA is now reporting at least one SGLT2 gangrene infection associated death and 11 other injuries in which the patients have been hospitalized and undergone surgery. The FDA has identified 12 confirmed cases of Fournier’s gangrene between March 2013 and May 2018.

In 2017, about 1.7 million American patients filled SGLT2 inhibitor prescriptions at pharmacies, according to the FDA. The safety warning includes a number of SGLT2 inhibitors, aimed at lowering blood sugar in adults with type 2 diabetes, including:

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

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Patients should seek medical attention following drug-induced symptoms of fever, tenderness, redness, or swelling of the genitals or the area around the genitals. Infection and symptoms can worsen quickly, so it is important to seek treatment as soon as possible. If a gangrene infection is suspected, start treatment immediately with broad-spectrum antibiotics and discontinue the SGLT2 inhibitor, and provide appropriate alternative therapy for glycemic control.

Joe Lyon is a highly-rated Ohio catastrophic injury lawyer and Cincinnati product safety attorney investigating SGLT2 gangrene infection cases and representing injured plaintiffs nationwide.

SGLT2 Gangrene Infection Risks & Treatment

Having diabetes is the primary risk factor for developing Fournier’s gangrene. The invasive bacteria can enter the body through a cut or laceration and spread quickly. In cases studied by the FDA, an infection developed within several months of the patients starting taking an SGLT2 (sodium-glucose cotransporter-2) inhibitor.

First approved in 2013, SGLT2 inhibitors help lower blood sugar by inducing the kidneys to remove sugar from the body through the urine. The infection, called necrotizing fasciitis of the perineum, is also medically referred to as Fournier’s gangrene. The FDA is not recalling any products, however it is requiring a new Medication Guide warning added to the prescribing information of all SGLT2 inhibitors.

SLGT2 Inhibitor Warnings & Health Risks

Recent studies published by The New England Journal of Medicine concluded that diabetes patients taking SGLT2-inhibitors are at an increased risk of lower limb amputation, bone fractures, kidney and liver failure and heart attacks.

Invokana has been a target for the FDA and consumer safety attorneys of late for a potentially elevated risk of lower limb amputations. The FDA has advised prescribing doctors to discontinue the medication for patients who experience symptoms such as pain, sores or extremity infection.

Fournier’s gangrene is a very rare but dangerous bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. The bacteria can quickly spread and destroy the tissue they infect.

FDA-Approved SGLT2 Inhibitors with the following active ingredients have been noted as potential for severe side effects:

• Canagliflozin
• Metformin
• Dapagliflozin
• Saxagliptin
• Empagliflozin
• Linagliptin
• Ertugliflozin
• Sitagliptin
  

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If you or a loved one has suffered a SGLT2 gangrene infection, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.