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The U.S. Food and Drug Administration has issued a safety communication about a potential association between SGLT2 inhibitors and serious adverse events such as amputations and a severe form of gangrene that attacks the genitals. If you or your loved one received treatment with Jardiance or other SGLT2i drug and you suffered amputations or Fournier’s gangrene, also called necrotizing fasciitis of the genitals you may qualify to seek significant compensation. Contact us today to learn more about Jardiance lawsuit eligibility. Our highly experienced drug injury lawyers will protect your rights throughout the entire legal process and ensure you get the maximum compensation available by law for your injuries and losses.
Who Uses Jardiance?
Empagliflozin, sold under the brand name Jardiance is an oral antidiabetic medication that is used as an adjunct therapy with diet and exercise to control blood glucose levels in adults with type 2 diabetes. It is classified in a group of drugs called SGLT2 inhibitors which work by blocking glucose from being absorbed by the kidneys and causing more to be removed from the body in urine. Jardiance was approved by the FDA in 2014.
Jardiance Side Effects
Unfortunately, while marketed and promoted as a safe and effective treatment for type 2 diabetes, treatment with Jardiance has been associated with Fournier’s gangrene, which is sometimes diagnosed as:
- Fournier’s disease
- flesh-eating bacterial infection
- gangrene of the genitals
- necrotizing fasciitis of the genital, perineum, or perianal areas.
According to the FDA communication to healthcare providers and patients, the agency reviewed five years of research and determined that some type 2 diabetes patients who are treated with Jardiance or another SGLT2 inhibitor may develop a rare but potentially deadly form of gangrene that specifically attacks genital tissue. This is rapidly-progressing necrotizing fasciitis may start with genital or anal tissue and quickly spread to the inner-thighs, abdomen, buttocks, and chest. Complications associated with Fournier’s gangrene may include sepsis, organ failure, and death.
It is extremely important that any patient who develops necrotizing fasciitis receives medical attention as quickly as possible. Immediate therapy with antibiotics is required, and all dead and decaying tissue must be removed from the body to stop its progression. Most patients will require hospitalization, and some will remain in the hospital for extended periods of time. Follow-up care is often necessary, and many patients will require reconstructive surgery and possibly adaptive aids.
Jardiance Patients May be Entitled to Significant Compensation
Prescription drug makers have a legal responsibility to ensure their medications are safe before they are released on the market. They have a high duty to warn the healthcare community and patients who depend on the medication of any side effects and adverse events associated with the drug. When they fail their duties and responsibilities, they may be held legally accountable for damages caused by their medications.
We have taken on some of the biggest pharmaceutical giants in the country and recovered billions in compensation on behalf of our clients. We ensure the rights of our clients are protected throughout the legal process and that they get the maximum compensation available by law for damages. If you suffered amputation or gangrene of the genitals after starting treatment with Jardiance, contact us today to for a free consultation. We do not charge a fee for talking with you, and we won’t charge you a fee for taking your case. We take the financial risks, so you can focus on your injuries, and we collect our fee when you win your case.
SGLT2 Inhibitors and Genital Gangrene
Even though diabetics have an increased risk of amputation and even gangrene, an FDA review of medical literature and reports to the Adverse Events database found that those who are treated with SGLT2 inhibitors may face increased risks of gangrene and infection. The FDA identified six cases of genital gangrene over the last 30 years in patients who were treated with antidiabetic medications other than SGLT2is. By comparison, the agency identified 12 cases of genital gangrene over only a five-year period in patients who were treated with SGLT2i medications like Jardiance.
Of the 12 cases of SGLT2i associated gangrene cases, each developed the gangrene relatively early in treatment, and each was required to undergo at least one debridement surgery, and several had to have multiple surgeries to ensure all dead and decaying tissue located and removed. Several of the patients developed serious health complications from the gangrene, and one patient succumbed to these complications.
Since the FDA released the safety communication in August 2018, hundreds of patients have called our injury hotline to report they were diagnosed with necrotizing fasciitis of the genitals. Many of these patients say there were left severely disfigured, some lost limbs, and some required multiple reconstructive surgeries. Unfortunately, we continue to receive calls like this every day.
Symptoms of Fournier’s Gangrene
If you or someone you love takes Jardiance or another SGLT2 inhibitor, you should be aware of the symptoms of Fournier’s gangrene and seek immediate medical attention if any of the symptoms are experienced. These symptoms include:
- general feeling of unwell accompanied by a low-grade fever of 100.4 or more.
- Pain and swelling of the genital and anal areas
- Foul odor coming from the affected area
- Crackling sound when the tissue is rubbed
- Red or dusky looking skin or skin with a purplish black hue
The FDA advises that diabetic patients on SGLT2 inhibitors do not stop taking their medications. If you are concerned about Jardiance and genital gangrene speak to your physician about your concerns work out a treatment plan together. If you experience any symptoms listed, you should seek medical attention immediately. Gangrene progresses rapidly and can quickly lead to severe and potentially deadly health consequences including organ failure and death.
We Can Help
Our attorneys have decades of experience protecting the rights of those who are seriously injured by the medications they need and depend on for their health and well-being. We work side-by-side with patients to hold drug manufacturers accountable for their products and ensure our clients the maximum redress available by law for their injuries and losses. Contact us now to learn more including whether you are eligible to seek compensation through a Jardiance lawsuit.