The type-2 diabetes drug Xigduo XR contains two medications that have been linked to elevated acid levels, including lactic acidosis and diabetic ketoacidosis. The label has also been updated to warn about kidney failure as a complication of severe urinary infections.
Need a Texas Xigduo XR 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 a severe side effect, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: FDA Strengthens Kidney Injury Warnings
June 2016 — The FDA issued a Safety Communication to warnings about the risk of acute kidney injury from Xigduo XR. The agency has received over 100 confirmed reports. Risk-factors include common medications like diuretics, blood pressure drugs (ARBs and ACE inhibitors), and painkillers like ibuprofen. Click here to read more.
What is Xigduo XR?
Xigduo XR is a once-daily oral medication that helps adults with type-2 diabetes control their blood-sugar levels. It was created by AstraZeneca and approved by the FDA in October 2014. It helps prevent hyperglycemia (high blood sugar) with a combination of two medications:
- Dapagliflozin: Sold alone under the brand-name Farxiga. It belongs to a new class of diabetes drugs, sodium glucose co-transporter 2 (SGLT2) inhibitors, that helps the kidneys remove glucose (sugar) from the body in the urine.
- Metformin HCl extended-release: First-line treatment for diabetes since the 1950s.
What is the problem?
Xigduo XR contains two medications that have both been linked to life-threatening side effects involving too much acid in the bloodstream. The Prescribing Information carries a so-called “Black Box” warning about lactic acidosis, a severe side effect of metformin. Recently, the FDA has also warned about reports of diabetic ketoacidosis associated with dapagliflozin.
Xigduo Side Effects
Xigduo and Kidney Failure
Xiguo and other SGLT2 inhibitors remove sugar from the blood through the kidneys. Uncontrolled diabetes can damage the kidneys and cause nephropathy. Unfortunately, Xigduo may further increase the risk of kidney side effects because it relies on the kidneys to remove extra sugar from the body.
The label on Xigduo has been updated to include warnings about urinary infections that spread to the kidneys and cause kidney failure. Infections can also cause scarring in the kidneys and chronic kidney disease. Because Xigduo is a diuretic, one of the most common side effects is dehydration, which can impair renal function due to low blood pressure and decreased blood-volume.
FDA Safety Warning for Xigduo XR
In May 2015, Xigduo XR was named in a Drug Safety Communication in which the FDA warned that all new diabetes drugs in the SGLT2 inhibitor class had been linked to a life-threatening side effect known as diabetic ketoacidosis (ketosis).
The European Medicines Agency (EMA) reported that as of May 19, at least 101 cases of diabetic ketoacidosis had been reported worldwide in patients on diabetes drugs in the SGLT2 inhibitor class. The agency warned:
“All cases were serious and some required hospitalisation. Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports blood sugar levels were only moderately increased. These uncharacteristic blood levels could delay diagnosis and treatment.”
What is Ketoacidosis?
Many people with diabetes die from diabetic ketoacidosis every year. This condition is caused by low insulin levels, which forces the body to start burning fat cells for fuel. The breakdown of fat cells releases toxic acids known as ketones, which build up in the body and cause complications. Ketoacidosis is treatable in a hospital, but untreated cases can result in deadly cerebral edema (brain swelling) or coma.
Symptoms of Diabetic Ketosis
Diabetic ketosis can develop in less than 24 hours. Symptoms may include:
- Frequent urination
- Excessive thirst
- Increased appetite
- Deep, rapid breathing
- Nausea and vomiting
- Abdominal pain
- Fruity-smelling breath
- Dry mucous membranes
- Low blood pressure
- Confusion or coma
Xigduo Class Action Lawsuit
Our attorneys are nationally recognized class action lawyers in Texas, but we are not filing a Xigduo class action at this time. Instead, we are filing individual lawsuits and only accepting cases involving very serious side effects.
Need a Xigduo XR Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Xigduo XR lawyers for a free lawsuit review.