Xigduo XR is a diabetes medication that contains dapagliflozin, an ingredient linked to dozens of cases of diabetic acidosis. In December 2015, the FDA ordered AstraZeneca to strengthen warnings about this life-threatening side effect.
Need a Texas Xigduo 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 ketoacidosis, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Xigduo XR and Diabetic Ketoacidosis (DKA)
Xigduo XR contains dapagliflozin and the extended-release version of metformin. It is manufactured by AstraZeneca and was approved in October 2014. Xigduo XR belongs to the SGLT2 inhibitor class of diabetes medications, which remove sugar from the body in urine.
In December 2015, the FDA warned about the risk of ketoacidosis from Xigduo XR in a Safety Communication. The agency received 73 reports of patients who were hospitalized with ketoacidosis after taking an SGLT2 inhibitor between March 2013 and May 2015.
In all of 2015, dapagliflozin was linked to 80 reports of metabolic acidosis, according to a report (PDF) on FDA adverse events by the Institute for Safe Medication Practices (ISMP).
Xigduo “Black Box” Warning
The Prescribing Information (PDF) for Xigduo XR has a “Black Box” warning about the risk of lactic acidosis from metformin. Like ketoacidosis, this side effect also causes too much acid in the bloodstream.
What is Ketoacidosis?
Diabetic Ketoacidosis (DKA), also known as metabolic acidosis, occurs when the blood and body fluids become too acidic due to toxins called ketones. Ketones are produced when the body metabolizes fat for energy rather than using glucose (sugar) in the bloodstream from food.
What Causes Ketoacidosis?
Ketoacidosis is most common in people with type-1 diabetes who missed a dose of insulin and have uncontrolled blood-sugar levels. Other risk-factors include recent illness (cold, flu, diarrhea, vomiting, etc.), trauma, infection, stress, eating less than normal, and more.
What Should I Do?
The FDA recommends discontinuing Xigduo and seeking emergency medical attention if you develop symptoms of ketoacidosis. You can check your ketone levels with a urine test strip.
Symptoms of Ketoacidosis
In patients on Xigduo, ketoacidosis can occur even when blood-sugar levels are normal or only slightly increased. Symptoms may include:
- Nausea
- Vomiting
- Abdominal or stomach pain
- Tiredness
- Trouble breathing
- Confusion
- Unconsciousness
How Is Diabetic Acidosis Treated?
Hospitalization is usually necessary to treat acidosis. The goal of treatment is decreasing acidity in the blood and balancing blood-sugar levels, if necessary. Most patients receive intravenous (IV) fluids, electrolytes, minerals like potassium, and insulin. With treatment, ketoacidosis is usually reversible without long-term complications. Most patients go home in a day or two.
Need a Xigduo Lawyer in Texas?
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