The Food and Drug Administration (FDA) is warning consumers that a certain diabetes drug may cause a flesh-eating bacterial infection in the genital region.
ABC 21 reports the FDA issued the warning Wednesday, stating several cases of Fournier’s gangrene have been reported in connection with sodium-glucose contransporter-2 (SGLT2) inhibitors, which is a medicine approved to lower blood sugar in adults with type 2 diabetes.
Fournier’s gangrene is a life-threatening bacterial infection that can be found in tissue underneath the skin that surrounds muscles, nerves, fat and blood vessels. The bacteria usually gets into the body via a cut or break in the skin.
According to the FDA, between March 2013 and May 2018, 12 cases of Fournier’s gangrene have been identified in patients taking one of the inhibitors. The cases include seven men and five women, all of whom where hospitalized and required surgery. One patient died as a result of the infection.
The FDA believes there may be unreported cases related to the inhibitor. Patients should seek medical attention immediately if they show signs of Fournier’s gangrene, which include the following symptoms: tenderness, redness, or swelling of the genitals; possess a fever above 100.4 F; or general feeling of being unwell.
Also, stop using the SGLT2 inhibitor immediately. The following SGLT2 inhibitors are FDA-approved:
- Invokana
- Active ingredient(s): canagliflozin
- Invokamet
- Active ingredient(s): canagliflozin and metformin
- Invokamet XR
- Active ingredient(s): canagliflozin and metformin extended-release
- Farxiga
- Active ingredient(s): dapagliflozin
- Xigduo XR
- Active ingreident(s): dapagliflozin and metformin extended-release
- Qtern
- Active ingredient(s): dapafliflozin and saxagliptin
- Jardiance
- Active ingredient(s): empagliflozin
- Glyxambi
- Active ingredient(s): empagliflozin and linagliptin
- Synjardy
- Active ingredient(s): empagliflozin and metformin
- Synjardy XR
- Active ingredient(s): empagliflozin and metformin extended-release
- Steglatro
- Active ingredient(s): ertugliflozin
- Segluromet
- Active ingredient(s): ertugliflozin and metformin
- Steglujan
- Active ingredient(s): ertugliflozin and sitagliptin