AstraZeneca’s new treatment for type-2 diabetes, Farxiga, has been linked to a risk of kidney failure and a life-threatening medical condition involving too much acid in the blood called diabetic ketoacidosis (DKA).
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Farxiga induced injury cases in all 50 states. If you or somebody you know was diagnosed with a severe side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
UPDATE: Farxiga Linked to Genital Infections
In August 2018, the FDA issued a Safety Communication after 1 person died and 11 others were hospitalized with a severe genital infection called necrotizing fasciitis of the perineum (Fournier’s gangrene) after taking diabetes drugs in the SGLT2 inhibitor class.
What is Farxiga?
Farxiga (dapagliflozin) is prescribed to help people with type-2 diabetes control their blood-sugar levels. It helps the kidneys remove sugar from the body through the urine, which lowers blood-sugar levels.
When AstraZeneca gained approval for Farxiga in January 2014, it was only the second FDA-approved drug in a new class of diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.
Farxiga Side Effects
- Diabetic ketoacidosis
- Kidney infections
- Kidney failure
- Urinary tract infections
- Fournier’s gangrene (necrotizing fasciitis of the perineum)
Farxiga and Kidney Failure
Having diabetes is a risk-factor for kidney failure. Over time, excess sugar in the bloodstream damages delicate structures in the kidneys, which can lead to nephropathy.
The problem is that Farxia relies on the kidneys to work and increases the amount of sugar that is processed through the kidneys. This is why Farxiga is not recommended for people with moderate to severe renal impairment. Kidney function should also be tested before and during treatment with Farxiga.
How Could Farxiga Cause Kidney Problems?
Experts are concerned that Farxiga could increase the risk of kidney side effects in several ways. Because it is a diuretic, one of the most common side effects is dehydration. This can deplete fluid levels and the amount of blood in the body, which makes it harder for the kidneys to do their job.
Farxiga is associated with a high risk of urinary infections, including rare cases of infections that spread to the kidneys and cause kidney failure. Infections can also scar the kidneys and cause chronic kidney disease.
Invokamet and Kidney Injury
In June 2016, the FDA strengthened warnings about acute kidney injury from Invokana. The agency received 101 confirmed cases of acute kidney injury from March 2013, when Invokana was approved, until October 2015.
Common Medications Increase Risk of Kidney Injury
Risk-factors for acute kidney injury include dehydration, decreased blood volume, chronic kidney insufficiency, congestive heart failure. Medications like diuretics, blood pressure drugs (ARBs and ACE inhibitors), and NSAID painkillers like ibuprofen also increase the risk of kidney injury.
FDA Warning: SGLT2 Inhibitors and Diabetic Ketoacidosis
In May 2015, Farxiga and other drugs in the SGLT2 inhibitor class have been linked to a risk of diabetic ketoacidosis, according to a Safety Communication from the FDA. In December, the FDA updated the label on Farxiga to include ketoacidosis. If you are taking Farxiga, the FDA recommends:
Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.
What is Ketoacidosis?
Diabetic ketoacidosis is a condition that occurs when there is not enough insulin, which forces the body to burn fat cells for fuel. This releases ketones, an acidic waste product that build up in the urine and blood — sometimes with life-threatening consequences.
Recommendation for Patients
Without treatment, diabetics suffering from ketoacidosis can lapse into a coma and die. Therefore, the FDA recommends seeking medical attention if symptoms appear:
“Pay close attention for any signs or symptoms of acidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Seek medical attention immediately if you experience any of these symptoms.”
New Diabetes Drugs Linked to 101 Cases of Ketoacidosis
At least 101 cases of ketoacidosis have occurred in patients on SGTL2 inhibitors as of May 19, according to a new warning from the European Medicines Agency (EMA). The EMA warned about the risk of delayed diagnosis due to mild symptoms and relatively normal blood-sugar levels.
Was Farxiga Marketed “Off-Label” for Weight-Loss?
Public Citizen, a consumer advocacy group, has sent a letter demanding that the FDA issue warning letters and civil fines against AstraZeneca.
The group was concerned that AstraZeneca engaged in illegal “off-label” (unapproved) marketing to promote Farxiga for weight-loss. Farxiga has never been evaluated as a safe and effective treatment for weight-loss, but the fine-print on the label indicates that clinical trials suggested this benefit.
According to Public Citizen, the ads are misleading:
“By inflating the drugs’ perceived benefits, the advertisements dangerously skew the risk-benefit calculations made by physicians and patients in deciding whether to initiate or continue these therapies.”
Public Citizen warns that the risk of serious side effects should be considered against the benefit of weight-loss, including low blood pressure, urinary tract infections, yeast infections, bladder cancer, pancreatitis, and kidney failure.
Farxiga and Bladder Cancer
Farxiga was associated with 10 cases of bladder cancer during clinical trials. The FDA has asked AstraZeneca to warn doctors against prescribing Farxiga to high-risk patients, monitor rates of bladder cancer, and include warnings about this possible side effect on the label.
Farxiga Class Action Lawsuit
Our attorneys are nationally recognized class action lawyers in Texas, but we are not filing a Farxiga class action at this time. Instead, we are filing individual lawsuits and only accepting cases involving very serious side effects.
Do I have a Farxiga Lawsuit?
The Schmidt Firm, PLLC is currently accepting Farxiga induced injury cases in all 50 states. If you or somebody you know was diagnosed with diabetic ketoacidosis, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.