Farxiga is designed to help control blood sugar levels in type 2 diabetics. The drug is classified as a sodium-glucose co-transporter-2 inhibitor, or SGLT2 inhibitor, and works by helping the kidneys eliminate glucose (sugar) from of the blood. Farxiga was developed in a partnership between AstraZeneca and Bristol-Myers Squibb, and approved by the U.S. Food & Drug Administration (FDA) in January 2014.
Farxiga May Cause Ketoacidosis: FDA Warning
On May 15, 2015, FDA issued a Drug Safety Communication warning that SGLT2 diabetes medicines had been linked to diabetic ketoacidosis (also known as DKA, diabetic acidosis or ketoacidosis). At least 20 reports of ketoacidosis in patients who took SGLT2 inhibitors were filed with the agency between March 2013 and June 6, 2014, according to the warning. Each patient required hospitalization or had to visit the emergency room.
The reports were unusual because most occurred in patients with type 2 diabetes, whereas DKA is typically only seen in individuals with type 1 diabetes, according to the FDA. “We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs,” the agency said.
- Flushed, hot, dry skin
- Blurred vision
- Feeling thirsty
- Frequent urination
- Drowsiness / difficulty waking up
- Rapid, deep breathing
- Strong, fruity breath odor
- Loss of appetite
- Abdominal pain
When diabetic ketoacidosis is severe, it must be treated in a hospital setting. Treatment involves administering insulin and fluids intravenously, and closely monitoring electrolyte levels. It usually takes a few days for the patient’s blood sugar levels to return to normal.
Farxiga Side Effects
- Diabetic ketoacidosis (DKA, diabetic acidosis metabolic acidosis, ketoacidosis)
- Heart attack (myocardial infarction or MI);
- Kidney failure;
- Urinary tract infections (UTIs);
- Yeast infections of the vagina or penis;
- Changes in urination, including urgent need to urinate more often, in larger amounts, or at night;
- Low blood sugar (hypoglycemia);
- Increased fats in your blood (bad cholesterol or LDL),
- And more.
Which Drugs are SGLT2 Inhibitors?
In addition to Farxiga, other type 2 diabetes medications in the SGLT2 inhibitor class include:
- Invokana (canagliflozin)
- Invokamet (canagliflozin and metformin)
- Jardiance (empagliflozin)
- Glyxambi (empagliflozin and linagliptin)
- Xigduo XR (dapagliflozin and metformin extended-release)
Farxiga Litigation Centralized in New York
April 13, 2017 – A panel of judges has agreed to establish a multidistrict litigation (MDL) for all federal product liability lawsuits involving the type 2 diabetes medications Farxiga and Xigduo XR in the U.S. District Court, Southern District of New York.
According to a Transfer Order (PDF) issued Thursday, at least 18 lawsuits alleging kidney damage or diabetic ketoacidosis from Farxiga or Xigduo XR have been filed in federal courts across the U.S.
Plaintiffs filed a petition with the U.S. Judicial Panel on Multidistrict Litigation (JPML) in February, stating that centralization would increase judicial efficiency. JPML agreed that the actions share factual questions arising from allegations, thus implicating numerous common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of Farxiga and Xigduo XR.
FDA Upgrades Farxiga Kidney Injury Warning
June 14, 2016 – Warning labels of the SGLT2 inhibitor diabetes drugs canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) have been revised to include information about a risk of acute kidney injury, according to an FDA Drug Safety Communication issued today. The agency approved canagliflozin in March 2013. From then until October 2015, at least 101 confirmable cases of the condition were reported in patients treated with the drugs.
New Analysis of Ketoacidosis Among Farxiga Users
February 1, 2016 – FDA continues to receive adverse event reports involving ketoacidosis among diabetes patents who take SGLT2 inhibitors like Farxiga. According to the most recent QuarterWatch (PDF) issued by the Institute for Safe Medication Practices (ISMP), at least 80 cases of DKA were reported among Farxiga users during the 12-month period ending June 30, 2015.
FDA Revises Farxiga Warning Label
December 4, 2015 – FDA added new warnings to the labeling of Farxiga and other SGLT2 inhibitor diabetes medications regarding ketoacidosis and severe urinary tract infections (UTIs). The new warnings and precautions will advise patients of these safety issues, and recommend that patients stop taking the drugs if they begin to present symptoms.
AstraZeneca Fails to Win FDA Backing for New Diabetes Drug
October 16, 2015 – AstraZeneca Plc failed to win U.S. approval for a new diabetes medication that combines dapagliflozin (the active ingredient in Farxiga) and saxagliptin (the active ingredient in Onglyza) after regulators asked for additional data that may require new clinical trials, according to Bloomberg News. Following yesterday’s deadline for the FDA to make a decision on an application seeking approval for the treatment, the agency issued a so-called “complete response letter,” requesting further data.
“This is clearly bad news for Astra,” said Sam Fazeli, an analyst with Bloomberg Intelligence. “It’s not clear how long they will have to wait.”
Do I Have a Farxiga Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Farxiga lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Again, if you or a loved one was injured by the side effects of Farxiga (generic: dapagliflozin), you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.