Farxiga Lawsuit in 2024: Get the Right Attorney

Overview

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 drug makers, AstraZeneca and Bristol-Myers Squibb, and approved by the U.S. Food & Drug Administration (FDA) in January 2014.

Farxiga May Cause Ketoacidosis: FDA Warning

According to the FDA, on May 15, 2015, the agency issued a Drug Safety Communication warning that SGLT2 diabetes medicines had been linked to diabetic ketoacidosis (also known as DKA, diabetic acidosis, or ketoacidosis) [1].

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.

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.

Ketoacidosis Symptoms

• 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
• Vomiting
• Confusion

Treatment

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:

• Invokamet
• 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 – According to an FDA, warning labels of the SGLT2 inhibitor diabetes drugs canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) have been revised to include information about the risk of acute kidney injury [2].

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 – The FDA continues to receive adverse event reports involving ketoacidosis among diabetes patients who take SGLT2 inhibitors like Farxiga.

According to the 2016 study issued by the Institute for Safe Medication Practices (ISMP), at least 80 cases of DKA were reported among Farxiga users during the 12 months ending June 30, 2015 [3].

FDA Revises Farxiga Warning Label

December 4, 2015 – The 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 – As claimed by Bloomberg News, 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 [4].

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.

Following yesterday’s deadline for the FDA to decide on an application seeking approval for the treatment, the agency issued a so-called “complete response letter,” requesting further data.

See all related dangerous drug lawsuits our attorneys covered so far.

FAQs

1. What Is Diabetic Ketoacidosis, and How Is It Linked to Farxiga Use?

Diabetic ketoacidosis (DKA) is a severe condition where the body produces excess acids (ketones). Farxiga use has been linked to increased DKA risk, especially in type 2 diabetics.

2. What Should Patients Know about the FDA Warnings Regarding Farxiga?

The FDA has issued warnings about Farxiga, highlighting the risks of diabetic ketoacidosis, severe urinary tract infections, and kidney injury. Patients should be aware and monitor symptoms closely.

3. How Does Farxiga Compare to Other SGLT2 Inhibitors in Terms of Risks?

Farxiga shares similar risks with other SGLT2 inhibitors, including DKA, kidney injury, and infections, but each drug’s specific side effect profile may vary slightly based on individual patient response.

Do I Have a Farxiga Lawsuit?

The Pharmaceutical Litigation Group at Schmidt & Clark, LLP 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.

References:

1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-revises-labels-sglt2-inhibitors-diabetes-include-warnings-about-too-much-acid-blood-and-serious
2. https://www.fda.gov/Drugs/DrugSafety/ucm505860.htm
3. https://www.ismp.org/sites/default/files/attachments/2018-01/2015Q4_0.pdf
4. https://www.bloomberg.com/tosv2.html?vid=&uuid=4ebbe727-74e0-11ef-ae1a-12d56fb1623a&url=L25ld3MvYXJ0aWNsZXMvMjAxNS0xMC0xNi9hc3RyYXplbmVjYS1mYWlscy10by13aW4tZmRhLWJhY2tpbmctZm9yLWNvbWJpbmVkLWRpYWJldGVzLWRydWc=