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More than 34 million Americans suffer from diabetes, and approximately 90 to 95% of diabetics have type 2 diabetes.

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, a class of prescription drugs used to lower blood sugar in adults with type 2 diabetes, are marketed as reducing the risk of end-stage kidney disease and other complications of type 2 diabetes. However, this class of drugs – which includes as Invokana, Farxiga and Jardiance, among others – may, in fact, cause serious complications that can lead to debilitating injury and even death.

In May of 2019 the Food and Drug Administration (FDA) issued a warning that drugs such as Invokana, Farxiga and Jardiance can cause a rare condition known as Fournier’s Gangrene: a necrotizing fasciitis of the perineal soft tissue and organs with a high rate of complication and death. As of 2019, the FDA required new warnings about this risk to be added to the prescribing information for all SGLT2 inhibitors and to the patient medication guide.

What is an SGLT2 drug?

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors are a class of FDA-approved prescription drugs used in combination with diet and exercise to lower blood sugar in type 2 diabetic adults. The job of these inhibitors is to cause the kidneys to remove sugar from the body. Given that there are more than 34 million Americans suffering from diabetes, with approximately 90-95% of those patients being diagnosed with type 2 diabetes, these drugs have a broad customer base.

Some of these drugs, such as Invokana, Farxiga and Jardiance, are marketed as being effective in reducing the risk of end-stage kidney disease and other type 2 diabetes complications. That sounds like a miracle for many diabetics until you realize that these medications can lead to debilitating injury and death – something patients are trying to avoid.

In August of 2018, the FDA issued a safety announcement that these medications have severely injured some SGLT2 drug users by causing a condition called Fournier’s Gangrene. As a result,  the FDA began requiring that new warnings about the health risk be added to the prescribing information of all SGLT2 inhibitors, including to the patient medication guide.

What is Fournier’s Gangrene?

Fournier’s Gangrene is a necrotizing fasciitis of the perineal soft tissue and organs. In other words, it’s a bacterial infection of the tissue under the skin around the genitals and surrounding area that causes death of the affected tissue, including muscle, nerves and blood vessels. While this condition is thought to be rare, it has the potential to cause disfigurement, complications, and even death.

Anyone who has been prescribed SGLT2 inhibitors should seek medical attention immediately if they experience any of the following symptoms:

  • Tenderness, redness, or swelling of the genitals or area between the genitals and rectum
  • Fever above 100.4 F
  • General feeling of being unwell

The symptoms of Fournier’s Gangrene can worsen quickly, so it is important to seek treatment right away. Seeking a fast diagnosis and medical treatment can mean the difference between life and death when it comes to this condition.

Diabetes patients need extra care taken when explaining the risks associated with medications they are prescribed. They still have a right to choose whether to accept a risk or look for another lower risk option to treat their diabetes. Without that knowledge, patients may not catch complications in time to help themselves.

If you or a loved one were prescribed an SGLT2 inhibitor and have been diagnosed with Fournier’s Gangrene, you may have a claim against the drug manufacturer and possibly the doctor who prescribed it to you without adequate warning of the risks. The highly experienced pharmaceutical product liability attorneys at Harris Lowry Manton LLP understand the importance of holding drug manufacturers and the medical community accountable for the harm they cause.

You have a right to pursue compensation for your injury and we help you secure what you deserve. Schedule your free case evaluation with one of our caring personal injury attorneys by calling our Savannah office at 912-651-9967, our Atlanta office at 404-961-7650, or by reaching out to us through our contact page to tell us your story.

 

 

 

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