Amanda Antell  |  December 26, 2018

Category: Diabetes

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FDA Warns Against SGLT2 Inhibitor Diabetes Drugs Linked to Fournier's GangreneCertain type-2 diabetes drugs have been linked to serious genital infections, including Fournier’s gangrene.

The FDA recently issued a notice warning that these rare and serious genital infections had developed soon after patients started their diabetes drugs’ prescriptions. The prescriptions reportedly started between March 2013 to May 2018.

A number of injury reports have been submitted over SGLT2 inhibitor diabetes drugs like Invokana and Jardiance, with seven men and five women reportedly developing Fournier’s gangrene genital infections.

So far, it has been confirmed that one patient has died from Fournier’s gangrene, while the other patients had suffered serious injuries that required surgical repair and hospitalization. In comparison to other type-2 diabetes drugs, the FDA says it only found six reports of Fournier’s gangrene in male patients in the past three decades.

The FDA is now requiring SGLT2 inhibitor manufacturers to update their diabetes drugs’ warning labels to include warnings of potential Fournier’s gangrene genital infections. The SGLT2 inhibitor diabetes drugs potentially associated with Fournier’s gangrene include:

  • Invokana
  • Invokamet/Invokamet XR
  • Farxiga
  • Xigduo XR
  • Qtern
  • Jardiance
  • Glyxambi
  • Synjardy/Synjardy XR
  • Steglatro
  • Segluromet
  • Steglujan

Overview of Diabetes Drugs Fournier’s Gangrene Correlation

SGLT2 inhibitor diabetes drugs work by signaling the kidneys to expel excess sugar through urination, which helps prevent blood glucose levels from getting too high. The first SGLT2 inhibitor was first approved by the FDA in 2013 and quickly became a popular choice for type-2 diabetes patients.

The FDA estimated that approximately 1.7 million patients received prescriptions for these diabetes drugs from a retail pharmacy in 2017. However, the recent association with Fournier’s gangrene has left many patients and doctors wary of these type-2 diabetes drugs.

Each of the SGLT2 inhibitors, except for Merck & Co.’s Steglujan, and the most recent addition to the medication class, has been linked to Fournier’s gangrene. AstraZeneca Pharmaceuticals recently stated that it is working with the FDA in updating Farxiga’s warning label.

Fournier’s gangrene is a genital infection that affects the perineum tissue, which sits under the skin covering the muscles, nerves, fat, and blood vessels. This infection can typically occur from a cut somewhere on the body, which allows infectious bacteria to enter and start attacking the tissue.

Patients who are currently taking SGLT2 inhibitors should be wary of any potential symptoms of Fournier’s gangrene. Patients who develop Fournier’s gangrene will experience redness and swelling in the genital area, along with fever and fatigue. Fournier’s gangrene can be potentially fatal and should be treated immediately.

Patients who have developed Fournier’s gangrene after taking SGLT2 inhibitor diabetes drugs may be eligible for compensation for their injuries and may benefit from participating in a diabetes drugs lawsuit investigation.

Join a Free Diabetes Medications & Flesh-Eating Infection Lawsuit Investigation

The type-2 diabetes medications linked to the flesh-eating infection include:

  • Invokana
  • Invokamet/Invokamet XR
  • Farxiga
  • Xigduo XR
  • Qtern
  • Jardiance
  • Glyxambi
  • Synjardy/Synjardy XR
  • Steglato
  • Segluromet
  • Steglujan

If you or a loved one took one of the type-2 diabetes medications listed above and suffered from a flesh-eating genital infection, you may qualify to join this diabetes medication lawsuit investigation. Fill out the FREE form on this page for more information.

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