By Emily Sortor  |  April 8, 2019

Category: Diabetes

Patient's hands with glucometerDiabetes drugs like Xigduo XR and Farxiga help people with type 2 diabetes manage their condition by enabling excess sugar to be expelled in the urine. They are part of a class of drugs known as SGLT2 inhibitors. However, these drugs can have serious side effects for patients despite their benefits in managing diabetes.

Farxiga is also known by its generic name dapagliflozin, and Xigduo XR is a combination of the drugs dapagliflozin and metformin.

Side Effects of Xigduo XR and Farxiga

In August, the FDA warned that medications made from SGLT2 inhibitors like dapagliflozin have been linked to a rare but serious infection of the genitals. This condition is called necrotizing fascitis of the perineum, also known as Fournier’s gangrene.

Dapagliflozin drugs cause excess blood sugar to be expelled in the urine, and having too much sugar in and around the genitals can reportedly increase a patient’s risk of infection. Some of these infections can be common, like yeast infections and urinary tract infections. However, some of these infections are more serious, like Fournier’s gangrene.

This bacterial infection typically enters the body through a cut or break in the skin. The condition is rare — the FDA has identified 12 cases of Fournier’s gangrene in patients taking drugs similar to Xigduo XR between March 2013 and May 2013.

In these patients, the condition reportedly developed several months after they began taking the drug. All 12 of these patients had to be hospitalized for their condition, and required surgery. Some patients required multiple, disfiguring surgeries, and some had complications related to their condition. Sadly, one patient died from Fournier’s gangrene.

In contrast, the FDA only identified six cases of Fournier’s gangrene in patients taking other diabetes drugs over thirty years of data.

Last summer, the FDA issued a warning about the possibility of developing Fournier’s gangrene as the result of Xigduo XR and Farxiga use.

What are the symptoms of Fournier’s gangrene?

Health Day notes that Fournier’s gangrene can first appear as redness, tenderness, and swelling of the genitals or the area around them, including the area from the genitals back to the rectum. These symptoms can be accompanied by a fever or a “general feeling of being unwell.” 

These symptoms may first not appear severe, but can worsen quickly and require medical attention. If the infection is severe enough, surgery may be required to remove the infected areas. Unfortunately, these surgeries can be disfiguring. However, the condition can be managed much better and these occurrences can be avoided the condition is identified and treated early.

Usage for Xigduo XR and Farxiga

According to dLife.com, a publication focusing on diabetes information, though the FDA warns patients of this serious condition, the agency still approved Farxiga and Xigduo XR for expanded use in patients with type-2 diabetes and moderate renal (kidney) impairment. So more patients may be able to benefit from these drugs, though there is still a risk of infections.  

This expanded use approval for these drugs came earlier this year and was based on a study of the performance of the drug, which reportedly “further confirmed the well-established safety profile for Farxiga and Xigduo XR” despite the drug’s rare but serious risks.

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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