Also known as Fournier’s gangrene, necrotizing fasciitis of the perineum has been diagnosed in at least 12 diabetes patients who took SGLT2 inhibitors (Invokana, Farxiga, Glyxambi, and others) from March 2013 to May 2018. All patients required hospitalization due to the severity of their symptoms, and one patient died, FDA said in a recall letter on Wednesday.
Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by the side effects of a diabetes drug, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the Problem?
August 29, 2018 – Type 2 diabetes medications from the sodium-glucose co-transporter-2 (SGLT2) inhibitor class that are affected by Wednesday’s FDA warning include:
- Invokana (canagliflozin)
- Invokamet (canagliflozin + metformin)
- Farxiga (dapagliflozin)
- Jardiance (empagliflozin)
- Glyxambi (empagliflozin + linagliptin)
- Xigduo XR (dapagliflozin + metformin)
SGLT2 inhibitor drugs work by removing excess sugar from the kidneys, thereby lowering a person’s blood-sugar levels. Medications from this class have also been linked to a serious side effect known as diabetic ketoacidosis (DKA), which occurs when when cells in the body are unable to get the glucose they need for energy.
Signs and symptoms of necrotizing fasciitis of the perineum include:
- Pain and swelling in the genitals or anal area
- Unpleasant odor coming from the affected skin tissue
- Crackling sound when touching the affected area
FDA is requiring manufacturers of these drugs to add information about the risk of Fournier’s Gangrene to their prescribing information and medicine guides given to patients. Diabetics using the drugs should seek immediate medical attention if they develop tenderness, redness or swelling of the genitals, and if they have even a slight fever of 100.4 degrees Fahrenheit, the agency said.
Do I Have a Diabetes Drug Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in diabetes drug lawsuits. We are handling individual litigation nationwide and currently accepting new Fournier’s gangrene cases in all 50 states.
Free Case Evaluation: Again, if you or a loved one has been diagnosed with necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, after taking an SGLT2 inhibitor drug, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.