Cases of Necrotizing Fasciitis, Serious Genital Infection with certain Diabetic Medications, FDA warns

By August 30, 2018Blog, Health, News, Public Health

The US Food and Drug Administration has put out a warning about certain Type II Diabetes medications causing cases of genital infection and necrotizing fasciitis in the perineum.

According to Medscape

“The new warning will be added to the prescribing information and the patient medication guides for all single and combination agents in the glucose-lowering SGLT2 inhibitor class of drugs approved to treat type 2 diabetes. Those drugs include the following:

  • Canagliflozin (Invokana, Invokamet, Invokamet XR; Janssen)
  • Dapagliflozin (Farxiga, Xigduo XR, Qtern, AstraZeneca)
  • Empagliflozin (Jardiance, Glyxambi, Synjardy, Synjardy XR; Boehringer Ingelheim/Eli Lilly)
  • Ertugliflozin (Steglatro, Segluromet, Stelujan; Merck)

Necrotizing fasciitis of the perineum, also called Fournier’s gangrene, is an extremely rare but life-threatening bacterial infection of the tissues underlying the skin surrounding the perineal muscles, nerves, fat, and blood vessels. It is estimated to occur in about 1.6 of 100,000 males annually in the United States, most often among those aged 50 to 79 years (3.3/100,000).

However, from March 2013 to May 2018, the FDA received reports of 12 cases of Fournier’s gangrene among patients taking SGLT2 inhibitors, of whom five were women and seven were men. The condition has rarely been reported among women. The patients ranged in age from 38 to 78 years.”

Read on at Medscape to find out about treatment options and what patients and healthcare professionals should do.

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