Xigduo Lawyers No Longer Reviewing Lawsuits
The product liability lawyers at Saiontz & Kirk, P.A. are no longer accepting new claims for individuals who have been hospitalized due to ketoacidosis or suffered kidney failure that may have been caused by side effects of Xigduo XR, which combines the new-generation diabetes drug Farxiga with metformin. This page is maintained for informational purposes only.
AstraZeneca introduced Farxiga in early 2014, as a member of a new class of diabetes drug that works in a unique way by impacting the normal function of the kidney. Only a few months later, Xigduo XR was introduced as a combination therapy that contains both Farxiga and the older diabetes drug metformin.
As a growing number of users report problems with Xigduo XR and Farxiga, it appeared that the drug makers may have failed to adequately research these new diabetes drugs or provide adequate warnings for consumers or the medical community about the risk of:
- Kidney Failure
- Diabetic Ketoacidosis (DKA), Ketosis or Acidosis
- Heart Attack or Stroke
- Wrongful Death
New cases are no longer being accepted.
Xigduo XR Problems
Xigduo (dapagliflozin and metformin) was approved in October 2014, only months after Johnson & Johnson’s Janssen subsidiary introduced their combination therapy Invokamet, which combines Invokana with metformin.
All of the drugs are part of a new class of medications introduced in recent years, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work in a unique way by impacting the normal function of the kidneys to cause more sugar to be excreted in the urine. This is designed to increase glucose production and lower blood glucose levels among diabetics. The addition of metformin decreases production of glucose in the liver.
As more diabetics use these new drugs, a growing number of adverse event reports have been submitted involving problems with Xigduo XR, Farxiga and other SGLT2 inhibitors.
It now appears that Xigduo XR side effects may increase the risk that individuals will suffer serious and potentially life-threatening injuries that are not adequately disclosed on the warning label for Xigduo XR or Farxiga.
▸ Xigduo XR Ketoacidosis Warnings
In May 2015, the FDA issued a drug safety communication about the potential link between Xigduo XR and ketoacidosis, ketosis, acidosis or other conditions involving a build up of acid levels in the blood, indicating that users of SGLT2 inhibitor diabetes drugs have been hospitalized or required emergency room treatment after suffering symptoms of the serious condition.
In December 2015, the FDA announced that it was requiring new label warnings on Xigduo XR and similar diabetes drugs, which would warn patients to stop using the drug immediately and seek medical assistance if they began experiencing signs of ketoacidosis.
While diabetic ketoacidosis (DKA) is a common side effect among individuals suffering from type 1 diabetes, it is not often seen among type 2 diabetics, which is what Xigduo is designed to treat.
In December 2015, the FDA announced that stronger Xigduo warnings will be required, indicating that users should stop taking the diabetes drug and seek immediate medical assistance if they experience side effects of ketoacidosis on Xigduo XR, which may include:
- Difficulty Breathing
- Nausea or Vomiting
- Abdominal Pain
- Confusion, Fatigue or Sleepiness
The agency urged users of the new diabetes drugs to be aware of the potential risk and to seek immediate medical treatment if they experience potential Xigduo XR problems.
Xigduo XR ketoacidosis lawsuits were reviewed as a result of the drug maker’s failure to provide adequate warnings at the time their new diabetes drug was introduced. New cases are no longer being accepted. This page is maintained for informational purposes only.
▸ Xigduo XR Kidney Failure Risk
As more diabetes patients are prescribed Xigduo XR, Farxiga, Invokana, Invokamet or other SGLT2 inhibitors, concerns have emerged about the potential risk of kidney failure as well.
Invokana was the first member of this new class of medications to hit the market, and it has been linked to a large number of adverse events involving kidney problems, including:
- Kidney Failure
- Kidney Impairment
- Kidney Stones
- Urinary Tract Infections
- Abnormal Weight Loss
- Hypersensitivity Reactions
Given the similar mechanism of action, there are concerns that Xigduo XR side effects may also increase the risk of kidney failure or other kidney damage.
The stronger warnings required by the FDA in December 2015 indicate that users should also seek immediate medical assistance if they show signs of a urinary tract infection, as this could be an indication of a more dangerous blood or kidney infection that could lead to kidney failure and even wrongful death.
Since the medications work by impacting the normal function of the kidney, some experts have raised questions about why the drug makers did not recognize the potential link between Xidguo and kidney failure before the medication was introduced. In addition, given the minimal benefits provided in treating type 2 diabetes, questions have been raised about whether the Xigduo XR risks may outweigh the benefits. As a result, the lawyers at Saiontz & Kirk, P.A. believe the FDA should consider requiring a Xigduo recall.
Xigduo Class Action Lawyers
Individuals hospitalized due to ketoacidosis or diagnosed with kidney failure may be entitled to financial compensation through a Xigduo class action lawsuit or individual injury claim. Potential claims for heart attacks and strokes were also being reviewed, as well as Xigduo wrongful death lawsuits. New cases are no longer being accepted. This page is maintained for informational purposes only.