FDA warning: necrotizing fasciitis of the perineum from diabetes medication – Fournier’s gangrene
October 4, 2018 — San Diego, CA. We are now learning about a rare but terrible condition called Fournier’s gangrene that could be linked to common diabetes medication. When the FDA publishes these warnings we investigate what the causes are. This is what we know so far from the FDA website.
From the FDA website: Actual text transcribes
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.
What are SGLT2 inhibitors – Diabetes medication
SGLT2 inhibitors are a class of prescription medicines approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.
In 2017, an estimated 1.7 million patients received prescriptions for an SGLT2 inhibitor from U.S. outpatient retail pharmacies.
Necrotizing fasciitis of the perineum
This rare condition is also known as Fournier’s gangrene (named after French venereologist Jean Alfred Fournier) and is classified as a polymicrobial necrotizing fasciitis of the perineal. It has a high mortality rate and people with this condition should medical help immediately for aggression intervention.
How many people have gotten Fournier’s gangrene from diabetes medication?
This is a rare disease, so far reports have listed one death and 11 people have been hospitalized. However there could be more that haven’t yet been reported. The FDA reports 12 cases of Fournier’s gangrene, seven are men and five are women from March 2013 through May 2018.
Type 2 diabetes medication (SGLT2 Inhibitors) with possible link to Fournier’s gangrene
Brand Name Active Ingredient(s)
Invokamet canagliflozin and metformin
Invokamet XR canagliflozin and metformin extended-release
Xigduo XR dapagliflozin and metformin extended-release
Qtern dapagliflozin and saxagliptin
Glyxambi empagliflozin and linagliptin
Synjardy empagliflozin and metformin
Synjardy XR empagliflozin and metformin extended-release
Segluromet ertugliflozin and metformin
Steglujan ertugliflozin and sitagliptin
Symptoms of necrotizing fasciitis of the perineum
People with necrotizing fasciitis of the perineum have reported having the following symptoms, but these may vary per person. If you have these symptoms –seek medical help immediately – this is a serious condition.
- Pain and or swelling in and or around the genitals or anal area
- Red or purple toned skin in affected areas
- Strong or foul odor from the affected area of the skin
- Cracking or dry skin sounds if the affected skin is touched
- Fever in some cases
Fournier’s gangrene -Treatment Options
The medical community states that this disease should be treated aggressively and most treatment options are high doses of antibiotics and in some cases surgery in the affected areas. Surgery should be performed at first within the first 24 hours, some may need unilateral orchiectomy. In some cases fecal passageways should be contained and/or re-routed from the affected areas.
Diabetes genital infection lawsuit – Now accepting cases
If you have been hospitalized or diagnosed with Fournier’s gangrene or suffer from an infection in your genitals or around your genitals, you may qualify to receive a large cash award and financial compensation from claims and settlements from this diabetes genital infection lawsuit. The lawyers and attorneys at Hood National Law Group are now accepting these debilitating flesh-eating genital infection cases.