FDA Warns Diabetes Drugs Can Cause Life-Threatening Genital Infections

8.30.2018

Patients taking a class of type 2 diabetes drugs are being advised by the U.S. Food and Drug Administration (FDA) of a link to a rare but serious flesh-eating infection of the genital area.

The FDA warned on Wednesday, August 29 that it has confirmed multiple cases of Fournier’s gangrene in patients taking SGLT2 inhibitors. Also known as necrotizing fasciitis of the perineum, Fournier’s gangrene is an extremely rare and life-threatening bacterial infection that attacks the genital region. The drugs affected by this warning include Invokana, Farxiga, and Jardiance.

According to the FDA health warning, 12 cases of Fournier’s gangrene were discovered in patients taking SGLT2 inhibitors in the U.S. Seven men and five women underwent surgery to treat the condition, with some patients requiring multiple disfiguring surgeries. Some patients developed complications, with at least one reported death. The FDA also acknowledges that more cases may be discovered.

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.

Patients taking SGLT2 inhibitors should seek immediate medical attention if they experience symptoms of Fournier’s gangrene, including tenderness, redness, or swelling of the genitals, or the area from the genitals back to the rectum, as well as a fever above 100.4 degrees Fahrenheit. The FDA advises that these symptoms can progress quickly, stressing the importance of seeking treatment as quickly as possible.

If you or a loved one have been diagnosed with Fournier’s gangrene after being prescribed SGLT2 inhibitors, contact Wexler Wallace using the form below to speak with an attorney.

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