Invokana and similar type 2 diabetes drugs known as SGLT2 inhibitors have been linked to a disturbing new side effect – necrotizing fasciitis of the perineum, a rotting of the genitals also called Fournier’s gangrene. The Food and Drug Administration (FDA) has ordered the drugs’ labels be updated to include a warning about this disturbing new side effect.
Diabetes is one of the risk factors for Fournier’s gangrene, however it is still extremely rare. From March 2013 to May 2018, the FDA identified 12 cases of Fournier’s gangrene in patients taking SGLT2 inhibitors. That number only includes cases that were reported to the FDA or reported in medical literature. The agency says it believes there may be additional cases about which it is unaware.
Of the 12 patients identified, seven were men and five were women. The condition developed within several months after patients started taking a SGLT2 inhibitor and, in most cases, treatment was stopped. All 12 patients were hospitalized and required surgery. Some patients required multiple disfiguring surgeries, and some developed complications. One patient died.
Comparatively, only six cases of Fournier’s gangrene – all in men – were identified in a review of other diabetic drug classes over a period of more than 30 years, the FDA reported.
This rare form of gangrene happens when body tissue is dead or dying (necrosis) due to lack of blood flow or a bacterial infection. Fournier’s gangrene involves an infection of the scrotum, penis or perineum, which is the area between the scrotum and anus for men and the area between the anus and vulva for women. This type of gangrene is typically found in the genitals and can stretch to the thighs, stomach and chest. The disease is most common in men but can affect women and children.
Patients taking an SGLT2 inhibitor should seek immediate medical attention if they experience any symptoms such as tenderness, redness, or swelling of the genitals or the area from the genitals to the rectum, and have a fever above 100.4 F, or a general feeling of being unwell. Symptoms of Fournier’s gangrene can worsen quickly, so medical treatment should be sought immediately.
SGLT2 inhibitors include the following brand-name drugs:
- Invokana, Invokana XR
- Xigduo XR
- Synjardy, Synjardy XR
Invokana, the first SGLT2 to be marketed in the U.S., is also linked to an increased risk of amputations.
Any adverse events related to these medications should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
FDA Safety Communication