A warning has been issued by the U.S. Food and Drug Administration for a popular Type 2 Diabetes Drug which has been linked to a flesh-eating bacteria infection around the genital area.
In a period spanning March 2013 to May 2018, 12 cases of Fournier’s gangrene were identified. The necrotizing fasciitis of the perineum occurs in people who took a sodium glucose cotransporter-2, or SGLT2.
Invokana, Farxiga, and Jardiance are all classified as SGLT2 inhibitors and are taken by around 1.7 million people annually in the U.S. SGLT2 inhibitors are drugs used to control blood sugar by forcing the kidneys to produce extra sugar in one’s urine.
Fournier’s Gangrene and SGLT2 Inhibitors
The FDA classifies Fournier’s gangrene as a rare and serious disease that kills soft tissue, muscle and blood vessels.
Anyone who shows any of the symptoms of Fournier’s gangrene — such as painful urination, swollen areas around the genitals and dehydration — should seek medical attention immediately. Other symptoms include anemia, cracked skins, and a fever.
When left untreated, Fournier’s gangrene can progress quickly and can result in sepsis and organ failure. This can result in hospitalization and sometimes death.
The FDA reported on 12 patients who wound up in the hospital — all of whom required “multiple disfiguring surgeries” and developed complications, including the death of one patient.
A risk factor of Fournier’s gangrene is diabetes, but it is uncommon for this to occur.
Men between 50-79 are prone to this disease — about 1.6 in 100,000 men suffer from Fournier’s Gangrene every year. However, of the 12 aforementioned patients, five were women.
Six cases of Fournier’s gangrene have been identified in diabetes patients in the last 30 years. The FDA says Fournier’s gangrene is the sixth disease attached to SGLT2 inhibitors since 2015. The FDA has now required any company who manufacturers SGLT inhibitors to add a risk warning for Fournier’s gangrene on bottles.
Call an Invokana Attorney today
If you or a loved one has suffered Fournier’s gangrene while taking an SGLT2 inhibitor such as Invokana, Farxiga or Jardiance, call pharmaceutical attorney Stephanie Lyons at Walton Telken Injury attorneys. The call if free and we will not collect fees unless we win your case.