What You Should Know About Fournier’s Gangrene

The U.S. Food and Drug Administration (FDA) issued a warning in late August 2018 about the link between diabetic medications and a rare, yet life-threatening disease called Fournier’s gangrene. The warning is specific to certain FDA-approved inhibitors (SGLT2), which are said to prevent the kidneys from reabsorbing sugar into the blood, therefore helping lower blood sugar, and the risk for heart attack and stroke in adults with type 2 diabetes. These medications include, but are not limited to, Invokana, Jardiance, and other SGLT2 inhibitors produced and distributed by global pharmaceutical companies. The warning was issued as a result of 12 confirmed cases of Fournier’s gangrene linked to taking SGLT2 inhibitors between March 2013 and May 2018. The FDA’s warning states that while there are only 12 confirmed cases linked to SGLT2 inhibitors, to include seven men and five women, the estimated 1.7 million patients who were prescribed these inhibitors in 2017 may potentially be at risk. The pharmaceutical attorneys at Napoli Shkolnik PLLC, along with the FDA, urge any individuals who are or may be experiencing symptoms to seek medical attention immediately. For patients and health professionals who notice side effects from using SGLT2 inhibitors, the FDA requests that you report your symptoms to the FDA MedWatch reporting program right away.

Today, the pharmaceutical lawyers at Napoli Shkolnik PLLC will share useful statistics and facts, and explain the risk factors and symptoms of Fournier’s gangrene. Should you or a loved one fall under the common risk factors or display symptoms, contact a health professional immediately. Then, reach out to Napoli Shkolnik PLLC’s dedicated pharmaceutical litigation team to discuss your potential claim.

Understanding Fournier’s Gangrene

The Mayo Clinic defines gangrene as the “death of body tissue due to lack of blood flow or serious bacterial infection,” which typically affects the extremities. Fournier’s gangrene is a necrotizing infection that is extremely rare, yet often disfiguring and even fatal. This serious bacterial infection affects the tissue under the skin surrounding the soft tissues (muscles, nerves, blood vessels, and fat) of the genital organs; more specifically, the perineum between the vulva and scrotum. While Fournier’s gangrene typically affects men, there have been known cases in women and children.

Useful Stats and Facts

  • Fournier’s gangrene is characterized as “necrotizing fasciitis of the perineum and genitalia”.
  • SGLT2 inhibitors were first approved by the FDA in 2013.
  • SGLT2 inhibitors include dapagliflozin, canagliflozin, empagliflozin, and ertugliflozin.
  • The FDA-approved SGLT2 inhibitor brands include Invokana, Invokamet, Invokamet XR, Farxiga, Glyxambi, Jardiance, Qtern, Segluromet, Steglatro, Steglujan, Synergy, and Synergy XR.
  • Common side effects of SGLT2 inhibitors typically include urinary tract infection, yeast infections, and low blood pressure when combined with other diabetes prescription drugs.
  • The FDA reports 12 confirmed cases in seven men and five women.
  • All 12 cases were hospitalized and underwent surgery.
  • One patient died as a result of the bacterial infection; some patients underwent “multiple disfiguring surgeries;” and some patients developed complications from the infection.
  • In these cases, it is believed Fournier’s gangrene developed over the course of several months after patients began an SGLT2 inhibitor regimen and, typically, the use of the medication was terminated.
  • There have been more than 1,800 cases of Fournier’s gangrene reported worldwide since 1950.
  • Men are 10 times more likely to develop Fournier’s gangrene than women.
  • While men are typically affected, women and children have reported symptoms.
  • Fournier’s gangrene spreads quickly, affecting the area from the genitals (including the scrotum, testicles, penis, and/or perineum) to the rectum in men, and the vulva and anus for women, and may affect the thighs, buttocks, stomach, and chest.
  • Fournier’s gangrene occurs in 1.6 of 100,000 males annually in the United States.
  • In 2017, approximately 1.7 million patients were dispensed a prescription for an SGLT2 inhibitor through retail pharmacies across the United States.

Risk Factors

The most common risk factor for developing the incredibly rare Fournier’s gangrene is diabetes. For men with diabetes between the ages of 50 and 60, the risk is increased. Health professionals believe diabetes is the leading predisposing risk factor because of the link between the use of SGLT2 inhibitors and the onset of necrosis in the genitals. Furthermore, diabetes limits the production and the effects of insulin, the hormone that helps your cells gather blood sugar. Diabetes also causes blood sugar levels to spike, which can cause gradual damage to blood vessels when there is not enough blood flow to a certain part or parts of the body.

Symptoms of Fournier’s Gangrene

Symptoms typically develop quickly, so it is important to seek medical treatment immediately with the onset of the following symptoms:

  • Skin discoloration (often brownish-black in color) in the affected area
  • Swelling, tenderness, and redness in the genitals or area surrounding the genitals
  • Fever above 100.4 F
  • Sudden, severe pain
  • Numbness and/or tingling sensation
  • Abnormal discharge and/or unpleasant odor from discharge
  • Thin, shiny skin
  • Skin feels cold to the touch

Early Detection Is Key

It is imperative that individuals experiencing the above symptoms seek immediate medical attention from a healthcare professional, as early detection and treatment are key. A medical professional can examine the affected area and the symptoms to properly diagnose Fournier’s gangrene, and then determine a treatment plan. Treatment for Fournier’s gangrene may include antibiotics and surgical intervention, when appropriate. The FDA offers a medical guide to assist individuals in reviewing their prescribed medications, which is also given to them with their prescription.

Talk To Our Pharmaceutical Attorneys

If you or a loved one believe you have suffered an injury or death as a result of taking SGLT2 inhibitors for diabetes, or have developed Fournier’s gangrene as a result of your diabetes medication regimen, you may be entitled to compensation. Our team of compassionate pharmaceutical lawyers is highly experienced in pharmaceutical litigation, and can talk with you to determine how to move forward with your claim. With our primary offices in New York City and additional offices located in California, Delaware, Florida, Illinois, New Jersey, Texas, and Michigan, we are ready to assist you.  Please reach out to Napoli Shkolnik PLLC for a free, no-obligation case evaluation with one of our dedicated personal injury attorneys. We are passionate about fighting for your justice, so contact us today to get started.