Life-threatening genital infection found in some using common diabetes drugs, FDA says

The U.S. Food and Drug Administration issued a warning on Wednesday that it’s found cases of a rare but life-threatening, flesh-eating genital infection in people taking a certain type of diabetes drugs.

Three of the drugs covered by the warning are the commonly used Invokana, Farxiga and Jardiance, according to Bloomberg.

Others are made by Bristol-Myers Squibb, Merck & Co and Pfizer Inc., Reuters reported. The full list covered by the warning is on the FDA website.

They belong to a class of type 2 diabetes drugs called SGLT2 inhibitors that “lower blood sugar by causing the kidneys to remove sugar from the body through the urine,” the FDA said in its safety announcement.

The FDA estimated that 1.7 million people in the United States last year got a prescription for an SGLT2 inhibitor from a retail pharmacy.

Between March of 2013 - the first year this class of drugs was approved - and May 2018 the FDA “identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor,” the agency reported.

All were hospitalized and needed surgery, the FDA said. One patient died.

Fournier’s gangrene has shown “a predilection for patients with diabetes,” according to the National Center for Biotechnology Information.

It’s an infective “necrotising fascitis” - flesh-eating - disease that invades the genitals and the genital area, according to the NCBI, “which commonly affects men, but can also occur in women and children.”

The bacteria typically enter the body “through a cut or break in the skin, where they quickly spread and destroy the tissue they infect,” the FDA said.

“Having diabetes is a risk factor for developing Fournier’s gangrene; however, this condition is still rare among diabetic patients,” the agency said.

Published reports suggest Fournier’s gangrene is found in 1.6 out of 100,000 American men every year, mostly men ages 50 to 79, the FDA said.

“Although most cases of Fournier’s gangrene have previously been reported in men, our 12 cases included 7 men and 5 women,” noted the agency, which said there might be more cases it doesn’t know about.

The FDA is asking that new warnings about the gangrene risk be added to information given to patients who use all SGLT2 inhibitors.

AstraZeneca told Bloomberg it is already working with the FDA to update its labels “and noted that it hadn’t seen any cases of the condition during the development of Farxiga.”

The FDA recommended that patients and doctors watch for symptoms of the disease a - “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.”