At the end of August, the FDA warned that certain sodium-glucose cotransporter-2 (SGLT2) inhibitors have been linked to Fournier’s gangrene, a life-threatening “flesh-eating” infection.
Known as necrotizing fasciitis, Fournier’s gangrene infects the genital and perineal region of the person infected. Gangrene is characterized by dead or dying tissue caused by a lack of blood flow to the affected region. A bacteria may get into the body through a cut or break in the skin, and tissue that surrounds the muscles, nerves, fat and blood vessels are destroyed.
According to Mayo Clinic, side effects of Fournier’s gangrene include:
- Skin discoloration — ranging from pale to blue, purple, black, bronze or red, depending on the type of gangrene you have
- Swelling or the formation of blisters filled with fluid on the skin
- A clear line between healthy and damaged skin
- Sudden, severe pain followed by a feeling of numbness
- A foul-smelling discharge leaking from a sore
- Thin, shiny skin, or skin without hair
- Skin that feels cool or cold to the touch
The FDA identified 12 cases of Fournier’s gangrene in patients taking an SLGT2 inhibitor between March 2013 and May 2018. Among those, seven were men and five were women, all who were hospitalized and required to undergo surgery. Some needed multiple surgeries due to disfigurement, one patient died and others developed complications.
The agency noted even though Fournier’s gangrene is typically found in men between 50 and 79 years old, women and children may also be susceptible to contracting it. In a variety of cases, gangrene leads to scarring, reconstructive surgery or even amputation of the affected body part.
The FDA announced it would require a new warning to be placed on all SLGT2 inhibitors, some of which include canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, or other diabetes medications such as metformin.
The FDA indicated those who are on the following medications may be susceptible:
SLGT2 inhibitors fall within a class of medications for persons with type 2 diabetes. They lower blood sugar in the body by causing the kidneys to remove sugar through urine. In 2017, roughly 1.7 million patients were prescribed an SLGT2 inhibitor in the United States.
Side effects of SLGT2 inhibitors include yeast infections, urinary tract infections (UTI), and low blood sugar in conjunction with other diabetic medication. However, patients should seek immediate medical attention if they experience tenderness, redness, or swelling of the genital region to the rectum, and have a fever above 100.4 degrees, as the symptoms may worsen at a rapid pace.
Contact a Lawyer Who Handles Fournier’s Gangrene Lawsuits
If you or a loved one contracted Fournier’s gangrene and are prescribed diabetic medication, we would like to speak with you. You may be entitled to compensation by filing a lawsuit. Our lawyers respond promptly to all inquiries and would be honored to speak with you.