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Type 2 Diabetes Medication Causes Genital Infection, FDA Warns

 

The FDA released a public safety alert, warning type 2 diabetes patients taking SGLT-2 inhibitors that they may be at risk of developing necrotizing fasciitis of the genitals and genital area.

Necrotizing fasciitis of the genital area, also called Fournier’s gangrene, is a life-threatening flesh-eating bacterial infection of the skin surrounding the muscles, nerves, fat, and blood vessels in the genitalia. It is most common among men ages 50 to 79 and occurs in about 1.6 of 100,000 men annually in the US. It is very uncommon in women.

The FDA has mandated new prescribing information and patient medication guides making SGLT-2 patients aware of the increased risk of developing Necrotizing fasciitis for the following medications:

  • Canagliflozin (Invokana, Invokamet, Invokamet XR)
  • Dapagliflozin (Farxiga, Xigduo XR, Qtern)
  • Empagliflozin (Jardiance, Glyxambi, Synjardy, Synjardy XR)
  • Ertugliflozin (Steglatro, Segluromet, Steglujan)

type 2 diabetes medication genital infection

12 Reports of Type 2 Diabetes Medication Genital Infection

Since March 2013, the FDA has received 12 reports of type 2 diabetes patients prescribed SGLT-2 inhibitors who have developed necrotizing fasciitis of the genitalia – five women and seven men ranging from 38 to 78 years old. All of the four SGLT-2 drug-types except ertugliflozin were included in the reports – although there have been no reports so far, the FDA stated that ertugliflozin would be expected to run an equal risk to patients.

For these individuals, the window of development ranged from 7 days to 25 months after taking SGLT-2 inhibitors with an average of 9.2 months.

All 12 individuals who reported developing necrotizing fasciitis of the genitalia were hospitalized and underwent surgical procedure to remove the infection.

Five of the individuals underwent more than one surgical procedure. One individual required skin grafting. Four of the individuals dealt with post-surgical complications including diabetic ketoacidosis, acute kidney injury, and septic shock. There was one reported death. Two individuals were transferred to a rehabilitation hospital.

Type 2 diabetes increases the risk of Fournier’s gangrene.

However, an examination of all patients taking type 2 diabetic medications other than SGLT-2 inhibitors from 1984 to 2018 revealed that only six cases of Fournier’s gangrene occurred in patients, all of which were men.

Symptoms of Fournier’s gangrene include tenderness, redness, swelling of the genital area, or running a temperature of 100.4 degrees Fahrenheit or higher.

If you are prescribed an SGLT-2 inhibitor to treat type 2 diabetes, and you show any signs or symptoms of Fournier’s gangrene, seek medical attention right away.

Fournier’s gangrene is a degenerating disease, worsening over time. If caught in its early stages, Fournier’s gangrene can be treated with antibiotics; but if left untreated, surgical procedure may be necessary.

If you are taking an SGLT-2 inhibitor to treat type 2 diabetes, talk to your doctor about the risks of your medication and whether you are eligible for other 2 diabetic treatments.

If you are currently or were ever taking an SGLT-2 inhibitor, and as a result developed necrotizing fasciitis of the genital area / Fournier’s gangrene, contact the offices of TorHoerman Law. You may be eligible to participate in a (type 2 diabetes medication genital infection) lawsuit.

At this time, TorHoerman Law is collecting information for a potential type 2 diabetes medication genital infection lawsuit.

 

 

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