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Xigduo Ketoacidosis Lawsuit

Xigduo Ketoacidosis Lawsuit

AstraZeneca’s type-2 diabetes drug Xigduo is subject to a new FDA warning about diabetic ketoacidosis (DKA), a life-threatening side effect involving too much acid in the bloodstream.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Xigduo XR induced injury cases in all 50 states. If you or somebody you know has been diagnosed with 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 toll free 24 hours a day at (866) 920-0753.

What is the problem?

Xigduo helps people with diabetes control blood-sugar levels. It contains meformin extended-release (XR) and dapagliflozin, a new member of the SGLT2 inhibitor class. Dapagliflozin and other SGLT2 inhibitors work by forcing the kidneys to remove extra glucose (sugar) from the bloodstream in urine.

The problem is that dapagliflozin was linked to 80 cases of metabolic acidosis in 2015, according to a review (PDF) of side effect reports by the Institute for Safe Medication Practices (ISMP).

In May and December 2015, the FDA issued Safety Alerts about the risk of ketoacidosis from SGLT2 inhibitors, including Xigduo XR. The agency ordered AstraZeneca to update the Warnings & Precautions to include stronger warnings.

Does Xigduo Have a “Black Box” Warning?

Yes. There is a “Boxed Warning” about the risk of lactic acidosis in the Prescribing Information (PDF) for Xigduo XR. It is a side effect of metformin that causes too much acid in the blood and body tissues.

What is Diabetic Ketoacidosis?

Patients on Xigduo XR, especially those with uncontrolled diabetes, can develop diabetic ketoacidosis (DKA). This condition, also called metabolic acidosis, occurs when the blood and body fluids are too acidic.

DKA is caused by a buildup of ketones, which are produced when the body metabolizes fat. It usually occurs when there is a shortage of insulin and the body can’t use blood-sugar (glucose) from food for energy.

The risk of DKA increases for people who have recently had an infection, surgery, illness (cold, flu, vomiting, etc.), reduced fluid or food intake, emotional stress, trauma, and more. Unfortunately, infections are some of the most common side effects of Xigduo.

What Should I Do?

Patients on Xigduo XR should be vigilant for symptoms of ketoacidosis and seek emergency medical attention if symptoms appear. In many cases, blood-sugar levels are only slightly higher than normal. Therefore, it is a good idea to use urine test strips to check ketone levels.

The most common symptoms of ketoacidosis include:

  • Nausea
  • Vomiting
  • Abdominal or stomach pain
  • Tiredness
  • Trouble breathing
  • Confusion
  • Unconsciousness

How Is Ketoacidosis Treated?

In the hospital, patients will receive intravenous (IV) medications and fluids to balance blood acidity. They typically receive fluids, minerals (potassium), electrolytes, and insulin. With treatment, most people suffer no long-term health problems and go home in a couple days.

Do I have a Xigduo Lawsuit?

The Schmidt Firm, PLLC is currently accepting Xigduo XR induced injury cases in all 50 states. If you or somebody you know has been diagnosed with 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 toll free 24 hours a day at (866) 920-0753.

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