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![A search of the FDA Adverse Event Reporting System (FAERS) database from
March 2013, when the first SGLT2 inhibitor was approved, to February 2018 and
the medical literature through May 2018 identified 12 cases of Fournier’s
gangrene in patients taking an SGLT2 inhibitor
[8-29-2018] The U.S. Food and Drug Administration (FDA) is warning that cases
of a rare but serious infection of the genitals and area around the genitals have
been reported with the class of type 2 diabetes medicines called sodium-glucose
cotransporter-2 (SGLT2) inhibitors.
necrotizing fasciitis of the perineum or Fournier’s gangrene, can progress
quickly and must be treated immediately because it can cause severe damage
to the tissues around the genital area.](https://image.slidesharecdn.com/sglt2inhibitorsandnecrotizingfasciitis-180910094330/75/SGLT2-inhibitors-and-RISK-OF-necrotizing-fasciitis-2-2048.jpg)
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SGLT2 inhibitors and RISK OF necrotizing fasciitis
A search of FDA reports and medical literature identified 12 cases of Fournier's gangrene in patients taking SGLT2 inhibitors. Fournier's gangrene is a rare but serious genital infection that can progress quickly and requires immediate treatment to prevent severe tissue damage. Patients taking SGLT2 inhibitors should seek medical attention immediately if they experience tenderness, redness, swelling or fever in the genital or rectal area as symptoms can worsen rapidly. Healthcare providers should assess patients with these symptoms for Fournier's gangrene, start broad-spectrum antibiotics and surgery if needed, discontinue the SGLT2 inhibitor, and provide alternative diabetes treatment.
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SGLT2 inhibitors and RISK OF necrotizing fasciitis
- 2. A search ofthe FDA Adverse Event Reporting System (FAERS) database from March 2013, when the first SGLT2 inhibitor was approved, to February 2018 and the medical literature through May 2018 identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor [8-29-2018] The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. necrotizing fasciitis of the perineum or Fournier’s gangrene, can progress quickly and must be treated immediately because it can cause severe damage to the tissues around the genital area.
- 3. Patients should seekmedical attention immediately if : symptoms of : • Tenderness • Redness • swelling of the genitals or the area from the genitals back to the rectum, • and have a fever above 100.4 F (40C) or a general feeling of being unwell. • These symptoms can worsen quickly, so it is important to seek treatment right away.
- 4. Health care professionalsshould : • assess patients for Fournier’s gangrene if they present with the symptoms • 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.