A new FDA warning alerts type-2 diabetes patients that certain diabetes drugs increase the risk of a potentially life-threatening genital infection.

More than a dozen drugs in a class of drugs known as SGLT-2 inhibitors (sodium-glucose cotransporter 2 inhibitors) are included in the FDA warning. SGLT-2 inhibitors were first approved by the FDA in 2013, and are prescribed to help reduce blood sugar levels in type-2 diabetes patients.

The FDA warning advises type-2 diabetes patients taking these SGLT-2 inhibitors of increased risk of developing a rare bacterial infection known as necrotizing fasciitis of the perineum, or Fournier’s gangrene, a potentially deadly infection of the genitals and the area surrounding the genitals.

The bacterial usually enters the body through broken skin, and can spread rapidly. Both males and females are at risk for infection.

Well-known and heavily advertised diabetes drugs like Invokana, Farxiga, and Jardiance are included in the FDA warning. Other SGLT-2 inhibitors that are part of the FDA warning are:

  • Invokamet
  • Invokamet XR
  • Xigduo XR
  • Qtern
  • Glyxambi
  • Synjardy
  • Synjardy XR
  • Steglatro
  • Segluromet
  • Steglujan

Patients taking any of the aforementioned drugs should be on the lookout for any of the following symptoms:

  • Swelling of the genitals
  • Swelling in the area from the genitals to the rectum
  • Tenderness in the genital area
  • Redness in the genital area

If you experience any of these symptoms AND have a fever higher than 100.4 degrees, or a general feeling of sickness, get medical help immediately. The infection must be treated quickly with antibiotics and surgery.

One death and 11 hospitalizations have been reported since FDA approval of the SGLT-2 inhibitors in 2013. A medical study found a 20% mortality rate for those suffering from the infection.

The FDA further stresses that patients using this drug read the accompanying Medication Guide each and every time they refill their prescription to look for important new information about risks or side effects.

The FDA also requests that patients taking this drug, or any drugs, report any adverse reactions or side effects they experience. Reports can be filed through the FDA MedWatch voluntary reporting system at https://www.fda.gov/safety/medwatch/default.htm or by calling 1-800-332-1088.