FDA warns of genital gangrene risk with diabetes drug class

The US regulator released an official risk warning of a rare genital infection identified in 12 patients, including one fatality, after using  SGLT2 class drugs for type 2 diabetes.

The infection has been identified in seven men and five women in the US in the last five years, but the FDA warned that more patients have been affected.

All patients have been hospitalised with one registered fatality, several cases with a need of disfiguring procedures and some developing complications.

The necrotising fasciitis of the perineum, also known as Fournier’s gangrene is a rare, but life-threatening infection of the tissue under the skin that surrounds muscles, nerves, fat and blood vessels of the perineum.

The bacteria usually enter the body through a cut or break in the skin, and can quickly spread and destroy the infected tissue.

Diabetes is known a risk factor for developing Fournier’s gangrene; however, this condition is still rare among diabetic patients with only six cases in the last 30 years.

The FDA has warned patients to seek immediate medical attention in the case of any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, accompanied with high fever.

Healthcare professionals have received information to start treatment immediately of any newly identified cases with broad-spectrum antibiotics, surgery if necessary and to discontinue the SGLT2 inhibitor providing appropriate alternative therapy.

The regulator asked pharma companies to revise medical information attached to their SGLT2 products to include the new warning risk.

SGLT2 inhibitors were first approved by the FDA in 2013 for use with diet and exercise to lower blood sugar in adults with type 2 diabetes and currently include Janssen’s Invokana, Eli Lilly & Co’s Jardiance, as well those from Bristol-Myers Squibb, AstraZeneca, Merck & Co and Pfizer.

In 2017, an estimated 1.7 million US patients received a dispensed prescription for an SGLT2 drug.

In May this year, the FDA also requested SGLT2 drug manufacturers to include warnings about the risk of ketoacidosis and serious urinary tract infections, conditions which might result in hospitalisation.