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FDA WARNS ABOUT SERIOUS GENITAL INFECTION RELATED TO INVOKANA AND SGLT2 DIABETES INHIBITORS

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FDA WARNS ABOUT SERIOUS GENITAL INFECTION RELATED TO INVOKANA AND SGLT2 DIABETES INHIBITORS

Invokana and other sodium-glucose cotransporter-2 inhibitors for diabetes have been approved by the FDA to lower blood sugar by removing it through urine. The drugs have also been approved to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease.

On August 29, 2018, the FDA issued a safety alert regarding reports of serious infection of and in the area around the genitals caused by Invokana and other SGLT2 inhibitors. 

“Necrotizing fasciitis of the perineum” is the fast-advancing death of cells in the soft tissue of the perineal and perianal spaces between the legs and in the genital area. Sometimes, it even involves the abdominal wall and the two hips. This condition can occur in men and women. The FDA is requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient medication guide.

Symptoms of this serious infection include 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. These symptoms can worsen quickly, so it is important to seek treatment right away.

How bad is can it be? It is also commonly called “Fournier’s Gangrene”, which, is as bad as it sounds.

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