FDA Warning: Diabetes Drugs Linked to Flesh-Eating Genital InfectionClick here for a free case evaluation
What you need to know!
If you, or someone you know, has taken an oral medication to help control diabetes and developed Fournier’s gangrene or Flesh-Eating Genital Infection, please contact our Fournier’s gangrene attorneys at 1 (800) 515-1496 for a free case evaluation.
FDA warns of risk of genital gangrene linked to diabetes drugs.
The FDA announced that some Type 2 diabetes medications including Invokana have been linked to cases of “necrotizing fasciitis of the perineum,” a “flesh eating” genital infection also called Fournier’s gangrene. The warning comes after the FDA identified cases of the disease in patients taking a SGLT2 inhibitor over the course of 5 years, between March 2013 to May 2018.
The FDA wrote in its warning: “Seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 Fahrenheit or a general feeling of being unwell.” The agency continued, “These symptoms can worsen quickly, so it is important to seek treatment right away.”
The FDA is now requiring a new warning about the risk be added to all SGLT2 inhibitors.
What is Fournier’s Gangrene?
Fournier’s Gangrene is as a genital bacterial infection affecting the perineum, the area located in the genital region for both males and females. It is commonly known as flesh-eating bacteria and also called necrotizing fasciitis. Fournier’s Gangrene is rare but has a mortality rate of 20-30% according to a 2012 study published by ISRN Surgery and US National Library of Medicine.
According to the FDA Report: “Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. The bacteria usually get into the body through a cut or break in the skin, where they quickly spread and destroy the tissue they infect. Having diabetes is a risk factor for developing Fournier’s gangrene.”
The FDA saw an increase in patients identified with the flesh-eating bacteria in the past five years. In fact, the FDA saw double the number of patients with the disease in those five years compared to the number of recorded cases in more than 30 years.
FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
[8-29-2018] The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.
The FDA issued a drug safety communication indicating that drugs belonging to a class of medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors have been linked to cases of serious infections around the genitals. These drugs include:
• Invokamet XR
• Xigduo XR
• Synjardy XR
Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away. Treatment for Fournier’s gangrene include:
• Antibiotics given by IV (through your veins)
• Surgery to remove the dead and dying tissue
• Reconstructive surgery
• Hyperbaric oxygen therapy -- this means you are given pure oxygen while in a pressurized room
Fournier’s gangrene Lawsuits
The manufacturer failed to warn doctors and patients of the risks of taking SGLT2 Type-2 diabetes drugs. If patients would have known of the increased risk for Fournier’s gangrene, patients may have chosen a different drug to help treat their diabetes. In addition, patients could have been monitored closely for potential signs of problems.
Our Fournier’s gangrene Lawyers Can Help
If you or a loved one has taken a SGLT2 diabetes drug and developed Fournier’s gangrene, please contact our office at 1 (800) 515-1496, or or click on the button below, for a free case evaluation. You could be eligible for compensation from the drug manufacturer.
Click here for a free case evaluation