FDA Warns of Rare Genital Gangrene Linked to Diabetes Drugs

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On Aug. 29, the Food and Drug Administration (FDA) released a safety announcement warning of a potential link between a rare, destructive bacterial infection and diabetes drugs like Invokana, Farxiga and Jardiance.

Known as Fournier’s gangrene, the bacterial infection affects the genitals. The FDA has warned development of the infection may be related to the use of sodium-glucose cotransporter-2 (SGLT2) inhibitors, a class of diabetes drugs that will soon feature updated labeling.

Fournier’s gangrene, also referred to as necrotizing fasciitis of the perineum, is a rare disease with few known causes. It begins in the space between the anus and genitalia (perineum), but it can spread to the legs, torso, and chest.

Widespread antibiotics can slow or stop it in the early stages. If given time, Fournier’s gangrene can kill flesh in the infected areas requiring amputation and reconstructive surgery. Common symptoms can include pain and discomfort in the affected area, which may escalate into necrosis in months.

Fournier’s gangrene affects people between the ages of 50 and 79, and typically impacts men more than women. Though there have been 12 cases of Fournier’s gangrene, there has only been one reported fatality.

In 2017, over 2 million people were prescribed SGLT2 Inhibitors to control high blood sugar. Diabetes is a daily struggle that can be stressful, tiring, and even dangerous. It’s crucial that diabetes medications given to patients are safe and reliable.

According to the FDA, the onset of Fournier’s gangrene typically begins after nine months. The FDA advises anyone taking the medications listed below to immediately contact their doctor to be tested for Fournier’s.

“Healthcare professionals should assess patients for Fournier’s gangrene if they [are] present with the symptoms described,” according to the FDA. “If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary.”

Medication Name Parent Company Invokana, Invokamet, and Invokamet XR Johnson & Johnson Farxiga Astrazeneca Jardiance Eli Lilly and Boehringer Ingelheim Xigduo XR Astrazeneca Qtern Astrazeneca Glyxambi Boehringer Ingelheim Synjardy and Synjardy XR Boehringer Ingelheim Steglujan, Steglatro, and Segluromet Merck & Co.

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