FDA Warns of Serious Genital Infection Linked to SGLT2 Inhibitors for Diabetes

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Just last week, the Food and Drug Administration (FDA) released a new warning for SGLT2 inhibitors, a class of drugs used to lower blood sugar in adults with type 2 diabetes. According to the FDA, a serious bacterial infection known as necrotizing fasciitis has been reported in the genital area of some patients taking SGLT2 inhibitors. While this condition is rare and only 12 cases have been confirmed since 2013, necrotizing fasciitis spreads rapidly and can be deadly.

This isn’t the first dangerous side effect associated with SGLT2 inhibitors. Over the past five years, the FDA has released five safety communications about risks related to SGLT2 inhibitors, ranging from decreased bone density and increased acid in the blood to urinary tract infections and leg and foot amputations.

What are SGLT2 inhibitors?

SGLT2 inhibitors reduce blood sugar levels by preventing the kidneys from reabsorbing excess glucose so it’s excreted in the urine.

Drugs in this class include Invokana, Jardiance, Farxiga, Invokamet, Synjardy and Steglujan.

What is necrotizing fasciitis?

Also known as Fournier’s gangrene, necrotizing fasciitis is a rare bacterial infection that spreads quickly in the body and can cause death. Symptoms are broken down into two periods: early and late. Early symptoms of necrotizing fasciitis include fever, pain, and red or swollen skin, while late symptoms include ulcers, blisters, changes in color of the skin, dizziness, tiredness, diarrhea and nausea.

I’m taking an SGLT2 inhibitor. What should I do?

For all SGLT2 inhibitors, the FDA is requiring that a new warning for necrotizing fasciitis be added to both the prescribing information document for health providers and the patient medication guide.

If you are taking an SGLT2 inhibitor and begin to experience any of the symptoms above and/or swelling of the genital area, seek medical attention immediately. Once necrotizing fasciitis appears, it can progress to life-threatening symptoms within days, so understanding the warning signs and contacting your healthcare provider quickly is key.

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