Adverse effects from prescription drugs are extremely common, ranging from relatively minor inconveniences like dry mouth and drowsiness to serious complications that seem worse than the patient’s underlying condition. But while many patients are willing to risk common drug side effects, some are decidedly uncommon. This is the case with a class of type-2 diabetes drug, as a new study confirms a link between SGLT2 inhibitors and flesh-eating bacteria known as Fournier’s gangrene.
Back in August we reported on an FDA warning that it had discovered multiple cases of Fournier’s gangrene in patients taking SGLT2 inhibitors like Janssen Pharmaceutical’s drug Invokana. At the time, only 12 cases of Fournier’s gangrene were discovered in patients taking SGLT2 inhibitors. A new study, published in the Annals of Internal Medicine, confirmed significantly more cases of Fournier’s gangrene in patients receiving SGLT2 inhibitors.
Fournier’s gangrene, also known as necrotizing fasciitis of the perineum, is a rare bacterial infection that attacks the genital region and perineum. This infection of the genitals and scrotum usually gets into the body via a cut or break in the skin and infects tissue that surrounds the muscles, nerves, fat, and blood vessels of the perineum. The infection spreads quickly and destroys the tissue.
Researchers combed through the FDA’s Adverse Event Reporting System and published case reports to compile their research. Between March 1, 2013 and January 31, 2019, they identified 55 unique cases of Fournier’s gangrene linked to SGLT2 inhibitors in patients ranging from age 33 to 87.
According to the study, the onset of Fournier’s gangrene after initiating SGLT2 inhibitor treatment varied from 5 days to 49 months. All affected patients were extremely ill and underwent surgical debridement to remove the unhealthy tissue.
The study also reports that several patients experienced additional complications, including diabetic ketoacidosis, sepsis, acute kidney injury, and infection of lower extremities which required amputation. Three patients died as a result of Fournier’s gangrene.
The study concludes that Fournier’s gangrene is a newly identified safety concern in patients taking SGLT2 inhibitors for type-2 diabetes, and doctors should be aware of the possible complications and early warning signs.
This isn’t the first time SGLT2 inhibitors like Invokana have been linked to adverse effects. Patients have reported kidney failure and impairment, urinary tract infections, and diabetic ketoacidosis. In 2017, the FDA required a black box warning for the type-2 diabetes medication canagliflozin (Invokana, Invokamet, etc.) due to an increased risk of leg and foot amputations.
Anyone taking SGLT2 inhibitors should be aware of the early warning signs of Fournier’s gangrene, which include tenderness, redness, or swelling of the genital region, fever exceeding 100.4 degrees Fahrenheit, dehydration, and anemia. Patients should contact their doctor immediately if they suspect they may have Fournier’s gangrene.
0 Comments