The U.S. Food and Drug Administration is warning patients and doctors of a rare but, serious infection of the genitals have been reported with a common class of Type 2 diabetes medications called sodium-glucose cotransporter-2 (SGLT2) inhibitors.
The agency reports that in the five years between March 2013 and May 2018, 12 patients developed the condition, called Fournier’s gangrene. All were hospitalized and one patient died.
There may be additional cases which are unreported.
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 get into the body through a cut in the skin, where they quickly spread and destroy the tissue they infect.
“We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.” the FDA said in a statement.
Numerous SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with Type 2 diabetes.
SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.
Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. A chart of approved SGLT2 Inhibitors can be found below.
The FDA warning indicates patients should seek medical attention right away if they experience any symptoms of tenderness, redness, or swelling of the genitals or the area, and have a fever above 100.4 degrees Fahrenheit, the agency said.
Having diabetes is a risk factor for developing Fournier’s gangrene, however, the condition is rare among diabetic patients. Publications report that 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 (3.3 out of 100,000).
According to the FDA, an estimated 1.7 million patients received a prescription for an SGLT2 inhibitor from a U.S. retail pharmacy in 2017.
Patients and health care professionals are encouraged to report side effects involving SGLT2 inhibitors or other medicines to the FDA MedWatch program.