Xigduo XR, a once-daily drug for type-2 diabetes, has been linked to several life-threatening side effects involving too much acid in the bloodstream, including diabetic acidosis and lactic acidosis. The FDA has also updated the label to include kidney failure as a complication of severe urinary tract infections.
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 was diagnosed with a severe side effect, 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 us toll-free 24 hours a day at (866) 920-0753.
UPDATE: Xigduo XR Linked to Genital Infections
In August 2018, the FDA issued a Safety Communication after 1 person died and 11 others were hospitalized with a severe genital infection called necrotizing fasciitis of the perineum (Fournier’s gangrene) after taking diabetes drugs in the SGLT2 inhibitor class.
What is Xigduo XR?
Xigduo XR is a prescription medication developed by AstraZeneca for the treatment of adults with type-2 diabetes. It actually contains two different medications that help prevent hyperglycemia in different ways:
- Dapagliflozin: Created by AstraZeneca and sold alone as Farxiga, it belongs to the sodium glucose co-transporter 2 (SGLT2) inhibitor class and works by helping the kidneys excrete glucose (sugar) in urine.
- Metformin HCl extended-release: Since the 1950s, it has been a first-line treatment for people with diabetes. It works by decreasing the amount of insulin the body needs to maintain normal blood-sugar levels.
Black Box Warning: Lactic Acidosis
The Prescribing Information for Xigduo XR includes a “Black Box” warning about lactic acidosis, a severe side effect of metformin that occurs when too much lactic acid accumulates in the blood. The FDA has also warned about the risk of diabetic ketoacidosis from Xigduo XR.
Xigduo Side Effects
- Diabetic ketoacidosis
- Kidney infections
- Kidney failure
- Urinary tract infections
- Fournier’s gangrene (necrotizing fasciitis of the perineum)
Xigduo and Kidney Failure
Xigduo can potentially lead to kidney failure in several ways. The FDA has received reports of kidney failure in patients who developed severe urinary infections that spread to the kidneys. Bacterial infections that spread to the bloodsream (urosepsis) can also causes a sudden drop in blood pressure and acute kidney failure. Chronic (long-term) kidney failure can also occur after infections permanently scar the kidneys.
Another problem with Xigduo is that it significantly increases a patient’s risk of dehydration. Patients on Xigduo urinate much more frequently, which can decrease the amount of water and blood in the body. This makes it much harder for the kidneys to do their job.
Xigduo XR and Kidney Injury
In June 2016, the FDA strengthened warnings about acute kidney injury from Xidguo XR. The agency received 101 confirmed cases of acute kidney injury from March 2013, when Invokana was approved, until October 2015.
Common Medications Increase Risk of Kidney Injury
Risk-factors for acute kidney injury include dehydration, decreased blood volume, chronic kidney insufficiency, congestive heart failure. Medications like diuretics, blood pressure drugs (ARBs and ACE inhibitors), and NSAID painkillers like ibuprofen also increase the risk of kidney injury.
Xigduo and Diabetic Nephropathy
Type-2 diabetes is also a risk-factor for nephropathy, which is a kidney disease that occurs when excess sugar in the bloodstream damages the delicate filtering structures inside the kidneys after many years. Because Xigduo relies on the kidneys to work, some experts warn that it may further increase these risks. It is a good idea to check kidney function before starting treatment with Xigduo and periodically afterward. People with pre-existing kidney disease should not take Xigduo.
FDA Warning: Xigduo and Ketoacidosis
The U.S. Food and Drug Administration (FDA) received 20 reports of diabetic ketoacidosis in patients taking SGLT2 inhibitors between March 2013 and June 2014.
Xidguo XR was not approved until October 2014, but the FDA has continued to receive reports of this side effect and included Xigduo XR in a Drug Safety Communication published in May 2015. On December 4, 2015, the FDA updated the label on Xigduo to include ketoacidosis. If you are taking this medication, the FDA warns:
“Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.”
European Officials Warn About 101 Cases of Ketoacidosis
As of May 19, there have been at least 101 cases of ketoacidosis reported worldwide in patients on SGTL2 inhibitors, according to a new warning from the European Medicines Agency (EMA). Because symptoms may be relatively mild, there is an increased risk of complications due to delayed diagnosis:
“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 Diabetic Ketoacidosis?
Every year, many people with type-2 diabetes die from diabetic ketoacidosis. This medical condition occurs when the body starts burning fat as an energy source because it does not have enough insulin to use sugar (glucose) in the bloodstream. When fat cells are broken down, they release ketones — toxic acidic waste products — that accumulate until they cause complications.
Warning Signs & Symptoms
In some cases, symptoms of ketoacidosis appear in as little as 24 hours. They commonly 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.
Do I have a Xigduo XR Lawsuit?
The Schmidt Firm, PLLC is currently accepting Xigduo XR induced injury cases in all 50 states. If you or somebody you know was diagnosed with diabetic ketoacidosis or kidney failure, 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 us toll-free 24 hours a day at (866) 920-0753.
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