Xigduo XR, a type 2 diabetes drug made by AstraZeneca, has been linked to adverse health risks including diabetic ketoacidosis (DKA), kidney failure, heart attack, urinary tract infections (UTIs) and more.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by Xigduo XR, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturers and our lawyers can help.
Update: Xigduo XR Litigation Centralized in New York
April 13, 2017 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federal lawsuits involving Farxiga and Xigduo XR be centralized for pretrial handling in the Southern District of New York. JPML agreed that the actions share factual questions arising from the allegations, thus implicating numerous common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of Farxiga and Xigduo XR.
What is Xigduo XR?
Xigduo XR combines dapagliflozin and metformin hydrochloride extended-release to help manage blood sugar levels in patients with type 2 diabetes mellitus. The drug is classified as a sodium-glucose cotransporter-2 (SGLT2) inhibitor, and works by allowing extra blood sugar to be removed from the body through the urine. Xigduo is manufactured by AstraZeneca, and was approved by the U.S. Food & Drug Administration (FDA) in October 2014.
In addition to Xigduo XR, other type 2 diabetes medication in the SGLT inhibitor class include:
- Invokana (canagliflozin)
- Invokamet (canagliflozin and metformin)
- Farxiga (dapagliflozin)
- Glyxambi (empagliflozin and linagliptin)
- Jardiance (empagliflozin)
New Diabetes Drugs Linked to Ketoacidosis: FDA Warning
On May 15, 2015, FDA issued a warning regarding SGLT2 inhibitors and an increased risk of diabetic ketoacidosis (also known as DKA, diabetic acidosis, metabolic acidosis or ketoacidosis). This condition is characterized by the accumulation of acids called ketones in the blood, which if left untreated can lead to diabetic coma and even death.
From March 2013 to June 6, 2014, at least 20 cases of ketoacidosis in patients treated with SGLT2 inhibitors were reported to the FDA Adverse Event Reporting System (FAERS). Although the complication is typically found in type 1 diabetes patients with high blood sugar levels, most of the cases reported to FAERS involved type 2 diabetics with only slightly raised blood levels. Ketoacidosis is caused by low insulin levels in the blood, which forces body cells to burn fat instead of glucose for energy, resulting in the production of ketones.
All cases of ketoacidosis associated with SGLT2 inhibitors required emergency hospitalization or emergency room visits. Since June 2014, additional reports of the complication have continued to be received by the FDA.
Ketoacidosis Warning Signs
Diabetic ketoacidosis usually develops slowly; however, when vomiting occurs, the condition can develop within hours. Early symptoms include:
- Thirst or a very dry mouth
- Frequent urination
- High blood glucose (blood sugar) levels
- High levels of ketones in the urine
Later symptoms may include:
- Dry or flushed skin
- Nausea, vomiting, abdominal pain
- Difficulty breathing
- Fruity odor on breath
- Confusion / hard time paying attention
It is important to remember that ketoacidosis is a serious medical condition. If you are experiencing any of the above symptoms, call your doctor right away or go to the nearest hospital emergency room.
Xigduo Side Effects
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Acidosis, Ketoacidosis)
- Heart Attack (Myocardial Infarction or MI)
- Kidney Failure (Renal Failure)
- Kidney Cancer
- Kidney Infections (Pyelonephritis)
- Kidney Stones
- Bone Fractures
- Bone Abnormalities
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Lactic Acidosis
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
Black Box Warning
Because it contains metformin, Xigduo XR may increase the risk of lactic acidosis, which is caused by the buildup of lactic acid in the body. The condition occurs when cells make lactic acid (from glucose) faster than it can be metabolized. Xigduo XR labels contain a black box warning about the risk of lactic acidosis.
Has the Drug Been Recalled?
To date, no recall has been issued for Xigduo XR, and the drug continues to be prescribed to diabetes patients around the country. Xigduo XR settlements have not yet been paid to victims and the litigation is still ongoing. As more complaints continue to be filed, the expected settlement amounts will continue to increase. In order to be considered for a settlement, you should contact our lawyers immediately to learn more about your legal rights.
FDA Strengthens Kidney Warnings on Xigduo XR
June 14, 2016 – The FDA issued a drug safety communication today announcing that it has upgraded warning labels of the SGLT2 inhibitors canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) to include information about acute kidney injury and how to minimize risk for it. Between March 2013 and October 2015, the agency received reports at least 101 confirmed cases of the condition, some of which required hospitalization and dialysis, in patients treated with the drugs.
Do I Have an Xigduo XR Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Xigduo XR lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by the side effects of Xigduo XR, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and we can help.