FDA warns of flesh-eating genital infection linked to diabetes medication
By: Jacob Burbrink, Social Media and Digital Content Manager
(WPTA21) -
The Food and Drug Administration is warning people that some diabetes drugs may cause a flesh-eating bacterial infection of the genitals.
The FDA issued the warning Wednesday, saying cases of Fournier's gangrene have been reported in connection with sodium-glucose cotransporter-2 inhibitors. This is a class medicine approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. The FDA said the bacteria usually gets into the body through a cut or break in the skin.
While having diabetes is a risk factor for the infection, it is still rare. Publications report Fournier's gangrene occurs in 1.6 out of 100,000 males annually in the U.S., and most frequently occurs in males 50-79 years.
The FDA said in the five years from March 2013-May 2018, they identified 12 cases of Fournier's gangrene in patients taking one of the inhibitors. This is compared to only six cases identified in a review of other antidiabetic drug cases over a period of more than 30 years.
The cases included 7 men and 5 women. All of the patients were hospitalized and required surgery. The FDA said some patients required multiple disfiguring surgeries, some developed complications, and one patient died.
The FDA is concerned there may be additional cases that they are not aware of. Patients should seek medical help immediately if they experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell.
Healthcare professionals should assess patients for Fournier’s gangrene if they present with the symptoms described above. If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.
FDA-Approved SGLT2 Inhibitors
| Brand Name | Active Ingredient(s) |
|---|---|
| Invokana | canagliflozin |
| Invokamet | canagliflozin and metformin |
| Invokamet XR | canagliflozin and metformin extended-release |
| Farxiga | dapagliflozin |
| Xigduo XR | dapagliflozin and metformin extended-release |
| Qtern | dapagliflozin and saxagliptin |
| Jardiance | empagliflozin |
| Glyxambi | empagliflozin and linagliptin |
| Synjardy | empagliflozin and metformin |
| Synjardy XR | empagliflozin and metformin extended-release |
| Steglatro | ertugliflozin |
| Segluromet | ertugliflozin and metformin |
| Steglujan | ertugliflozin and sitagliptin |
The FDA is urging patients and healthcare professionals to report side effects involving SGLT2 inhibitors or other medicines to the FDA MedWatch program.
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