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Type 2 diabetes patients starting treatment with medications in a class of drugs called sodium-glucose cotransporter-2 inhibitors or SGLT2i drugs need to be aware of a recent FDA communication warning that these drugs have been associated with amputations and the development of flesh-eating bacterial infection attacks the genital tissues. Though typically diagnosed as Fournier’s gangrene, there are many synonyms for this extremely painful and dangerous condition, including:
- Fournier’s disease
- flesh-eating bacteria
- gangrene of the genitals
- necrotizing fasciitis of the perineum
- necro-fasciitis of the genitals
- necrotizing fasciitis of the genitalia
Patients who develop Fournier’s gangrene have rights and can speak with one of our SGLT2i lawyers to learn about those rights and ensure they are protected. Our lawyers can also help these patients determine if they are entitled to compensation.
Gangrene and Amputations from SGLT2 Inhibitors
The first SGLT2 inhibitor was approved in 2013 as an adjunct treatment for type 2 diabetes. They work by increasing the amount of blood sugar that is excreted in the urine and preventing it from being absorbed by the kidneys. Unfortunately, drugs included in this class of drugs have been associated with the development of Fournier’s gangrene. These drugs include:
- Invokana – active ingredient: canagliflozin – approved in 2013
- Invokamet – active ingredient: canagliflozin and metformin – approved in 2014
- Invokamet XR – active ingredient: canagliflozin and metformin extended-release – approved in 2016
- Farxiga – active ingredient: dapagliflozin – approved in 2014
- Xigduo XR – active ingredient: dapagliflozin and metformin extended-release – approved in 2014
- Qtern – active ingredient: dapagliflozin and saxagliptin – approved 2017
- Jardiance – active ingredient: empagliflozin – approved 2014
- Glyxambi – active ingredient: empagliflozin and linagliptin – approved 2015
- Synjardy – active ingredient: empagliflozin and metformin – approved 2015
- Synjardy XR – active ingredient: empagliflozin and metformin extended-release – approved 2016
- Steglatro – active ingredient: ertugliflozin – approved 2017
- Segluromet – active ingredient: ertugliflozin and metformin – approved 2017
- Steglujan – active ingredient: ertugliflozin and sitagliptin – approved 2017
Each of these drugs is now required to carry a warning for Fournier’s gangrene on the drug labels and in medication guides. Sadly, this does nothing to help the patients who have already been diagnosed with this rare and extremely painful type of gangrene.
Qualifying for SGLT2i Injury Compensation
If you were diagnosed with Fournier’s gangrene after being treated with an SGLT2 inhibitor, you might be entitled to seek compensation. Since the FDA warning about SGLT2 inhibitor medications association with Fournier’s gangrene, our SGLT2 lawyers have received hundreds of calls from patients and more come in every day.
Patients across the country who have been harmed by the prescription medications they rely on have turned to us for help holding drug makers accountable for the injuries their drugs have caused. We have handled some of the most significant drug injury litigation in the country, represented thousands of injured clients against pharmaceutical giants, negotiated tens of thousands of settlements, been awarded billions on behalf of our clients, and we are still going strong.
We’ve Recovered Billions of Dollars for Patients Harmed by Medications
We’ve been standing up to pharmaceutical giants for decades, and our attorneys have recovered billions of dollars in compensation for thousands of our clients. We battle mega-corporations, and we’ve won.
- Takeda Pharmaceuticals – Actos litigation – 900 clients – $180 million settlement
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- Abbott Laboratories – Depakote litigation – 300+ clients – $38 million in damages awarded
- Wyeth/AHP – Fen-Phen litigation – 350 clients – $70 million in damages awarded
- GlaxoSmithKline – Paxil birth defects litigation – 230 clients – $200 million settlement
- Bayer – PPA litigation – 50 clients – $19 million awarded
- Boehringer Ingelheim – Pradaxa litigation – 1,500 clients – $185 million in settlements
- AstraZeneca – Seroquel litigation – 300 clients – Confidential settlement
- Johnson & Johnson – Topamax litigation – 1 client – $4 million – confidential settlements for many more
- Merck – Vioxx litigation – 700 clients – $85 million in damages awarded
- Bayer – Yaz/Yasmin litigation – 700 clients – $100 million settlement
- Eli Lilly – Zyprexa litigation – 700 clients – $700 million global settlement
Fournier’s Gangrene Development Timeline
We’ve developed a brief timeline based on information provided by the FDA. In August 2018, the FDA published a warning communication regarding the association between SGLT2i drugs and the development of this type of gangrene that attacks the genitals. This form of gangrene progresses rapidly and can quickly spread to the anus, buttocks, stomach, chest, inner thighs, and hips. Complications from this type of gangrene include sepsis, the shut down of multiple organs, and possibly death.
Most patients who develop Fournier’s gangrene will need surgical reconstruction of the genital area, some may suffer amputations, and many will be left disfigured and scarred.
- Data were collected in 2001 and 2004 from 593 hospitals in 34 states to determine a rate of occurrence of Fournier’s gangrene and determined that it occurs in 1.6 out of every 100,000 males in the U.S.
- The FDA analyzed the FAERS database from March 2013 when the first SGLT2i drug was approved to February 2018 and reviewed medical literature through May 2018 and identified 12 cases of patients on SGLT2i drugs developing Fournier’s gangrene.
- By comparison, the FDA identified only six cases of Fournier’s gangrene in type 2 diabetes patients being treated with different antidiabetic medications over the past 30 years.
- Of the 12 SGLT2 patients identified by the FDA, seven were male.
- Five of the patients were female.
- The average time to onset was 9.2 months.
- The range of onset, or the time between the start of treatment and the development of gangrene, was between 7 days to 25 months, meaning patients developed the gangrene at any point between the first seven days of starting the medication to within the first 25 months of starting the medication.
- Each of the 12 patients required at least one debridement surgery to remove all dead and decaying tissue and some patients had to endure multiple debridement procedures.
- Several of the 12 patients developed complications from the condition.
- One of the 12 patients died from complications of Fournier’s gangrene.
Symptoms of SGLT2 Fournier’s Gangrene
Any patient who starts treatment with an SGLT2i drug to help control their type 2 diabetes should know the symptoms of SGLT2 inhibitor-associated Fournier’s gangrene. These symptoms include:
- Feeling generally unwell with a fever of 100.4 or higher
- Genital or anal swelling and pain
- Bad odor coming from the affected skin
- Red or dusky looking skin or skin with a purplish black hue
- Skin that sounds crackly if you rub it
Fournier’s gangrene is extremely painful, and it rapidly progresses. If you experience any of these symptoms after starting treatment with an SGLT2 inhibitor, seek medical attention right away. The complications of gangrene are severe and include sepsis, organ failure, and death.
Treatment for Fournier’s gangrene involves the administration of powerful, intravenous, broad-spectrum antibiotics and surgical removal of all the necrotic skin and affected underlying tissue. Additional surgeries may be required to ensure all necrotic tissue is removed.
Some who develop this gangrene may need assistive devices such as urinary catheters and colostomies, and some of these patients will depend on these devices for the rest of their lives. Most patients who develop this gangrene will require one or more reconstructive surgeries and many patients will be left disfigured and scarred. Some will suffer amputations, and unfortunately, some will suffer severe and life-threatening complications.
We Protect the Rights of SGLT2 Patients
Patients across the country are reaching out to our SGLT2 lawyers to find out if they qualify to seek justice and compensation for the severe injuries they suffered from these medications. If you or your loved one developed Fournier’s gangrene after being treated with an SGLT2 inhibitor, you may be entitled to significant damages, including:
- Current and expected future medical expenses
- Funeral expenses
- Loss of consortium
- Missed wages and lost work including lost earning capacity
- Physical pain and emotional suffering
- The increased expenses of living with a disability which may include home renovations for wheelchair access and the costs of in-home rehabilitation or nursing home expenses.
Patients started calling our firm within days of the FDA warning seeking advice and assistance. Hundreds have called us so far, and we are taking more calls daily. These patients want to know how to hold SGLT2i manufacturers accountable for the injuries their drugs caused.
Patients from across the country are working with our SGLT2 lawyers to get justice and compensation for their injuries and losses. These patients accuse the drug makers of failing to inform them of increased risks of developing Fournier’s gangrene, and they want to know why. These patients want to know when the drug makers knew or should have known about the association of SGLT2 medications and Fournier’s gangrene. By failing to warn of the association between these drugs and genital gangrene, patients say the drug makers denied them the opportunity to make informed healthcare decisions. Our clients will suffer the loss of limbs, scars, disfigurement, and for the rest of their lives. Families of those who died from complications of SGLT2i associated Fournier’s gangrene deserve justice.
Our attorneys have been fighting for the rights of patients for decades, and we stand ready to fight for justice for you and your family today. We make sure our clients get the compensation they need and the justice they deserve. Contact our firm today for information about SGLT2 lawsuits and whether you are entitled to seek compensation.