The condition, which is called necrotizing fasciitis and is referred to as Fournier’s gangrene, developed in 12 patients after they took the drugs between March 2013 and May 2018, the FDA said in an advisory Wednesday. All seven men and women were hospitalized, with one patient dying.
Fournier’s gangrene is an infection of the tissue under the skin that surrounds muscles, nerves, fat and blood vessels of the perineum. It usually gets into the body through a cut or break in the skin.
The FDA said Fournier’s gangrene occurs in 1.6 out of 100,000 males annually in the U.S., and most frequently occurs in males 50-79 years. The agency also noted that diabetes is a risk factor for developing the disease.
“Patients should seek medical attention immediately if you experience any symptoms of 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,” the FDA said. “These symptoms can worsen quickly, so it is important to seek treatment right away.”
The FDA is now requiring manufacturers to add information about the risk in the prescribing information and medicine guides for patients.
In 2017, an estimated 1.7 million patients received a dispensed prescription for an SGLT2 inhibitor from U.S. outpatient retail pharmacies, the FDA said. Bloomberg Intelligence reported the drugs are expected to generate as much as $7.1 billion in sales by 2020.
The only drug not in the class linked to the condition is Merck & Co.’s Steglujan.
Affected drugs include Johnson & Johnson’s Invokana, AstraZeneca Plc’s Farxiga and Eli Lilly & Co.’s Jardiance.
“Health care professionals should assess patients for Fournier’s gangrene if they present with the symptoms described above,” the FDA said. “If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels and provide appropriate alternative therapy for glycemic control.”