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FDA Warns of Severe Genital Infection with Diabetes Meds



August 30, 2018 – The FDA warns of rare cases of necrotizing fasciitis – sometimes called "carnivorous bacteria" – of the genitals and genital area in patients taking Type 2 diabetes medications known as SGLT2 inhibitors

The prescription Information and patient medication guidelines for all types of medicines and drug combinations approved for the treatment of type 2 diabetes are supplemented by warnings. They include:

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

Genital necrotizing fasciitis, also known as Fournier gangrene, is a life-threatening bacterial infection of the tissues under the skin that surround the muscles, nerves, fat, and blood vessels in the genital area. It is estimated that about 1

.6 out of every 100,000 men pass through the United States annually, most often between the ages of 50 and 79.

But from March 2013 to May 2018, the FDA received reports of 12 cases of Fournier gangrene in patients SGLT2 inhibitors, of which five were female and seven were male. The condition was rarely reported in women. The patients ranged from 38 to 78 years old.

The condition developed on average 9.2 months after starting the drug. (Development time ranged from 7 days to 25 months.) In most cases, patients stopped taking the drug.

Multiple Surgery, One Death

The reports all contained SGLT2 drugs except ertugliflozin, but "would have expected the same risk for this rare and severe infection as other SGLT2 inhibitors," the FDA said in a statement.

All 12 patients were hospitalized and had to undergo surgery to remove infected tissue. Five needed more than one operation and one needed skin graft. Four patients developed complications, including diabetic ketoacidosis, acute kidney injury and septic shock. One patient died and two were transferred to a rehabilitation hospital.

As diabetes makes Fournier's gangrene more likely, data were examined for patients taking other drugs that lower blood sugar. Between 1984 and 2018, only six cases of Fournier gangrene were identified, all in males.

Continued

An estimated 1.7 million patients received a prescription for a SGLT2 inhibitor in 2017 from US ambulant pharmacies.

Patients Medication should promptly seek medical attention if the tenderness, redness, or swelling of the genitals or genital area is greater than 100.4F.

The infection may quickly worsen, therefore, the patient advised to get help immediately.

The condition is treated with broad-spectrum antibiotics and surgery if needed. Patients should stop taking the medication and take other medications to control their blood sugar levels while monitoring their blood sugar levels.

The FDA is requesting patients to report side effects of taking this or other medicines to FDA MedWatch at 855-543-DRUG. 3784) and pressing 4; E-Mail [email protected]; or fill in an online form.

Medscape Medical News

Sources

FDA: "FDA warns of rare cases of severe genital infection with SGLT2 inhibitors for diabetes."


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