The type-2 diabetes drug Farxiga has been linked to a risk of diabetic ketoacidosis (too much acid in the blood) and severe urinary infections that lead to kidney failure, according to recent warnings from the FDA.
Need a Texas Farxiga Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a severe side effect, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: FDA Strengthens Kidney Injury Warnings
June 2016 — The FDA issued a Safety Communication to warnings about the risk of acute kidney injury from Farxiga. The agency has received over 100 confirmed reports. Risk-factors include common medications like diuretics, blood pressure drugs (ARBs and ACE inhibitors), and painkillers like ibuprofen. Click here to read more.
What is Farxiga?
Farxiga (dapaglifozin) is a prescription medication for the treatment of type-2 diabetes that is made by AstraZeneca. When it was approved in January 2014, it was the second drug in the sodium-glucose cotransporter-2 (SGLT2) inhibitor class to be approved by the FDA. The first was Invokana. All of these medications work by helping the kidneys excrete excess sugar in the urine.
Farxiga Side Effects
- Diabetic ketoacidosis
- Kidney infections
- Kidney failure
- Urinary tract infections
Farxiga and Kidney Failure
Kidney failure is a severe complication of uncontrolled diabetes. It occurs when excess sugar in the bloodstream damages delicate structures inside the kidneys that filter the blood (also known as nephropathy). Unfortunately, because Farxiga forces the kidneys to process even more sugar, some experts are concerned it could further increase the risk of kidney side effects.
In December 2015, the label on Farxiga was updated to warn about kidney failure as a result of urinary tract infections that spread to the kidneys. Bacterial infections in the kidneys can also cause scarring and chronic (long-term) kidney disease. Patients on Farxiga who become dehydrated due to its diuretic effect may also suffer from kidney problems.
FDA Warning: Farxiga and Ketoacidosis
In a Safety Communication issued on May 15, 2015, the FDA warned that all SGLT2 inhibitors, including Farxiga, were associated with diabetic ketoacidosis — a life-threatening condition involving too much acid in the bloodstream.
In December 2015, the FDA updated the label on Farxiga to include ketoacidosis. Between March 2013 and May 2015, the agency received 73 reports of the side effect in patients on SGLT2 inhibitors. Click here to read more.
The FDA warns:
“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.”
What is Ketoacidosis?
Acidosis occurs when there is too much acid in the body. Diabetic ketoacidosis occurs when the body produces high levels of acids known as ketones because it is breaking down fat cells instead of using glucose (sugar) in the bloodstream. Ketones can build up if there is too little insulin in the body.
European Officials Link SGLT2 Inhibitors and 101 Cases of Ketoacidosis
In June 2015, the European Medicines Agency (EMA) reported 101 cases of diabetic ketoacidosis worldwide in patients who used a diabetes drug in the SGLT2 inhibitor class. All of the cases were serious and some patients had to be hospitalized.
The EMA warned:
“ Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports blood sugar levels were only moderately increased. These uncharacteristic blood levels could delay diagnosis and treatment.”
Public Citizen: Farxiga Marketed “Off-Label” for Weight-Loss
In March 2015, the consumer advocacy group Public Citizen demanded that the FDA issue warning letters and civil fines against AstraZeneca for marketing Farxiga “off-label” for weight-loss.
Farxiga has fine-print on the label about studies suggesting a possible weight-loss benefit. However, Farxiga has not been deemed safe or effective for weight-loss and it has serious side effects, including low blood pressure, urinary tract infections, yeast infections, bladder cancer, pancreatitis, and kidney failure.
Public Citizen suggests 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.”
Farxiga and Bladder Cancer
During clinical trials, there were 10 cases of bladder cancer in patients on Farxiga. The FDA has asked AstraZeneca to monitor bladder cancer rates and include information about this potentially deadly side effect on the label. The FDA is also asking AstraZeneca to evaluate cardiovascular side effects in high-risk patients.
Farxiga Class Action Lawsuit
The Clark Firm, LLP is a nationally recognized class action law firm in Texas, but our attorneys are not filing a Farxiga class action at this time. Instead, we are filing individual lawusits and only accepting cases involving very serious side effects.
Need a Farxiga Lawyer in Texas?
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