Necrotizing fasciitis is a rare and extremely damaging genital disease that historically has affected almost no one; in the thirty-year span preceding 2018, the FDA recorded only six cases of American men developing it. Alarmingly, in just the past five years, 12 cases of Fournier’s gangrene, as the disease is commonly called, have been reported in both men and women taking one of thirteen diabetes drugs. Sold by prominent drug makers Eli Lilly / Boehringer Ingelheim, AstraZeneca, Merck, and Janssen / J&J, the diabetes drugs that cause genital infections are now the subject of an FDA diabetes drug infection warning. This page provides a comprehensive look at what researchers know about necrotizing fasciitis and diabetes drugs.

SGLT2 Inhibiting Diabetes Drugs

A relatively new form of diabetes medication, sodium glucose cotransporter 2-inhibiting drugs have gained popularity in the United States as a dominant treatment for Type 2 diabetes. By releasing excess urine through the bloodstream, SGLT2 inhibitors reduce dangerous blood glucose levels. Of the fourteen drugs approved by the FDA in this class, 13 diabetes drugs have been linked with severe and life-threatening genital infections. SGLT2 drugs include Farxiga, Xigduo XR and Qtern from Astra Zeneca, Jardiance, Glyxambi, Synjardy and Synjardy XR from Boehringer Ingelheim/Eli Lilly, Invokana, Invokamet and Invokamet XR from and Janssen/Johnson & Johnson, and Steglatro, Segluromet and Stelujan from Merck.

Necrotizing Fasciitis from Diabetes Drugs

Necrotizing fasciitis is the medical term for a very rare, flesh-eating genital infection. The infection starts when bacteria enter the skin through a cut or break; the infection rapidly spreads through the tissues, blood vessels, nerves, muscles, and fat beneath the skin in the genital area. The infection destroys any tissues it reaches, so rapid diagnosis and treatment are essential. The new FDA diabetes drug warning cites the following signs and symptoms of genital infections from diabetes drugs: tenderness, redness and swelling of the genitals or perineal area and a fever of 100.4 or greater.

Medical treatment for Fournier’s gangrene includes a broad-spectrum antibiotic and surgical debridement, or removal of the infected tissues. Depending on the severity of the infection, patients may require more than one surgical procedure, may be left permanently disfigured, and may develop other life-threatening conditions including acute kidney damage, septic shock, and diabetic ketoacidosis, or may die as a result of the genital infection.

FDA Diabetes Drug Infection Warning

In August of 2018, the FDA released its first information on the risk of genital infections from diabetes drugs in the form of a drug safety warning. The FDA diabetes drug warning cited 12 cases in twelve years where a patient taking Type 2 diabetes drugs developed a flesh-eating genital infection. Reports to the FDA are believed to represent only a percentage of actual incidents; likely, many more patients have developed necrotizing fasciitis as a result of diabetes medications.

The FDA diabetes drug warning, which concerns 13 of the fourteen drugs in the SGLT2 inhibitor class, requires manufacturers to include a genital infection warning on drug labels moving forward. Drug makers argue the benefits of this glucose-regulator still outweigh its risks, even in light of the risk of life-threatening genital infection. Consumer safety advocates say safe alternatives are available and argue manufacturers are guided by profit motives. The market for SGLT2 inhibiting diabetes drugs is projected to reach $7 billion by the year 2020, making this a massive market and creating significant vested interest among drug companies to gain market dominance despite drug dangers.

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