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Type 2 diabetes is considered one of the biggest health crises today with over 3 million cases a year in the United States. Sadly, some of the medications used to treat this very common condition may cause some patients to develop very uncommon conditions including gangrene of the genitals, ketoacidosis, and amputations.
The injuries sustained by patients on Farxiga or other medications included in the SGLT2 inhibitors classification can result in expensive medical treatments, additional home health care, the need for expensive assistive living devices and home modifications. Hundreds of patients have called our injury hotlines seeking legal advice and many want to hold Farxiga maker AstraZeneca accountable through a Farxiga lawsuit.
Many victims of dangerous drugs have received settlements and awards to help compensate them for their losses. In some cases, the families of patients who died from complications of conditions caused by antidiabetic medications have been eligible for wrongful death compensation.
What is Farxiga
Farxiga, dapagliflozin, belongs to a newer generation of antidiabetic medications all approved after 2013 called SGLT2 inhibitors. It is sold individually as Farxiga and in combination with metformin, sold under the brand name Xigduo XR.
Since it’s approval for the market, Farxiga has been associated with a range of adverse events and complications. The FDA has issued numerous warnings and safety communications involving Farxiga including:
- May 2015 – FDA warns Farxiga and other SGLT2i drugs may result in ketoacidosis, a condition in which there is too much acid in the blood. This condition may result in hospitalization.
- 2015 – FDA revises labels of Farxiga and other SGLT2i drugs to include warnings about ketoacidosis and severe urinary tract infections.
- 2015 – FDA warns of potential signals of serious risks identified by the agency’s Adverse Event Reporting system involving Farxiga and other SGLT2i drugs and acute kidney injury
- June 2016 – FDA strengthens existing warning about the risk of acute kidney injury for Farxiga, Invokana, Invokamet, and Xigduo XR.
- 2017 – FDA warns of potential signals of serious risks identified in the Adverse Events Reporting System involving Farxiga and other SGLT2i drugs and Fournier’s gangrene.
- 2018 – FDA warns of rare occurrences of a serious infection of genitals and the area around the genitals called necrotizing fasciitis of the perineum or Fournier’s gangrene. The new warning is added to labels of all SGLT2i drugs including Farxiga.
Most of the Farxiga lawsuits filed on behalf of patients accuse the manufacturer of:
- Manufacturing and distributing a dangerous or defective medication
- Failing to adequately warn the medical community and its patients about the risks of adverse events associated with the drug
- Knowingly concealing risks from the medical community
- Improper marketing and advertising of the medication
These patients are demanding to know when AstraZeneca knew or should have known about the increased risks of severe adverse events and why they didn’t inform the public of those risks.
Farxiga, Gangrene, and Amputations
Some Farxiga lawsuits were filed over patients suffering gangrene and amputations. Any patient who started treatment with Farxiga and then developed a bacterial infection that led to gangrene of the genitals and amputation, you may be entitled to seek significant compensation for your losses through a Farxiga lawsuit. Our attorneys are fighting for victims across the country who were treated with an SGLT2i medication like Farxiga and were then diagnosed with:
- Fournier’s disease
- Fournier’s gangrene
- flesh-eating bacteria
- gangrene of the genitals
- necrotizing fasciitis of the perineum
- necro-fasciitis of the genitals
- necrotizing fasciitis of the genitalia
The FDA issued a safety communication in August 2018 warning that Farxiga and other drugs in the same class were required to carry a warning on the label of an increased risk of developing Fournier’s gangrene or necrotizing fasciitis of the perineum. Sadly, some patients are also suffering amputations after starting type 2 diabetes therapy with Farxiga.
The FDA communications advised that some patients who are treated with an SGLT2i like Farxiga may develop a rare but rapidly progressing bacterial infection that can result in tissue death and decay resulting gangrene. These bacteria and resulting gangrene attack the tissues of the genitals and can quickly spread to the inner thighs, anus, buttocks, and abdomen. Severe health complications associated with Fournier’s gangrene include multiple organ failure, sepsis, and death.
How Rare is Fournier’s Gangrene?
According to the FDA, necrotizing fasciitis of the genitals is an extremely rare condition. The agency identified 12 cases of genital gangrene in patients treated with Farxiga and other SGLT2 inhibitors between 2013 and 2018. However, by comparison, only six cases of genital gangrene were identified over the last 30 years in patients who were treated with drugs other than SGLT2i medications.
Of the 12 SGLT2i patients identified by the FDA, all had to undergo at least one surgical procedure to remove the gangrenous tissue, and some of them had to have many additional surgeries to ensure all the dead and decaying tissue was located and removed. Some of these patients did develop complications, and one patient died from the severity of the complications.
If you are being treated for type 2 diabetes with Farxiga or similar medication, you should be familiar with the symptoms of Fournier’s gangrene:
- a general feeling of unwell accompanied by a fever over 100.4
- foul odor from the affected area
- genital or anal pain
- genital skin with a dusky, red, or purplish appearance
- the skin may make a crackling sound
- swelling of the genital or anal tissues
If you notice any of these symptoms, you must seek medical treatment immediately. The condition can rapidly progress allowing the infection to reach blood and bone. Treatment for genital gangrene involves administration of IV antibiotics and surgical removal of affected tissues. Patients who survive may require reconstructive surgery and assistive devices. Most are left with permanent scarring and disfigurement.
Farxiga Ketoacidosis and Kidney Injury
Farxiga lawsuits continue to mount against pharma giant AstraZeneca over allegations the drug increased the risks of acute kidney injury, bone fractures, and a dangerous condition in which the blood becomes acidic called ketoacidosis.
In 2017, with so many Farxiga lawsuits filed, the U.S. Judicial Panel on Multidistrict Litigation ordered all federally-filed cases be centralized to U.S. District Court for the Southern District of New York.
We Can Help
Any patient who suffers gangrene of the genitals or amputation after being treated with an SGLT2 inhibitor like Farxiga may qualify for significant financial compensation, but you can’t get a dime without a Farxiga lawsuit.
Hundreds of patients have called our firm to report they were diagnosed with gangrene and even lost limbs and the calls are continuing to come in. We’ve been fighting for injured patients for decades, and we know that you need and deserve the maximum amount of compensation available for the injuries and losses you have endured. Contact us now to learn if you qualify.