The U.S. Food and Drug Administration (FDA) said on Wednesday that a severe genital infection known as necrotizing fasciitis of the perineum, or Fournier’s gangrene, has been linked to type 2 diabetes drugs from the SGLT2 inhibitor class – at least one death and 11 hospitalized.
Free Confidential Lawsuit Evaluation: If you or a loved one has been harmed 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 against the manufacturer and our lawyers can help.
What’s the problem?
August 29, 2018 – Type-2 diabetes patients who take the following sodium-glucose co-transporter-2 (SGLT2) inhibitor drugs may have an increased risk of developing necrotizing fasciitis of the perineum, according to the FDA recall letter:
- Invokana (canagliflozin)
- Invokamet (canagliflozin + metformin)
- Farxiga (dapagliflozin)
- Jardiance (empagliflozin)
- Glyxambi (empagliflozin + linagliptin)
- Xigduo XR (dapagliflozin + metformin)
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. AstraZeneca said it is working with the FDA to updating the labeling, and noted that it hadn’t seen any cases of the condition in pre-approval studies on Farxiga.
Fournier’s Gangrene Symptoms
- Pain and swelling in the genitals or anal area
- Unpleasant odor coming from the affected skin tissue
- Crackling sound when touching the affected area
According to MedScape, necrotizing fasciitis of the perineum is treated with a broad spectrum antibiotic approach that covers staphylococci, streptococci, the Enterobacteriaceae family of organisms, and anaerobes. Surgery is necessary for accurate diagnosis and excision of necrotic tissue. Earlier surgical intervention has been associated with reduced mortality.
Do I Have a Diabetes Drug Class Action Lawsuit?
The Class Action 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 were diagnosed with necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, after taking a type 2 diabetes medication, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.