Published by If you or a loved one experienced diabetic ketoacidosis (DKA), kidney failure, heart attack, urinary tract infections, or other serious complications following Xigduo XR use, you may be entitled to pursue compensation.
At Schmidt & Clark, LLP, we are dedicated to helping individuals who have suffered due to dangerous diabetes medications.
Our experienced legal team is here to guide you through the process and fight for the compensation you deserve. Contact Schmidt & Clark, LLP today for a free, no-obligation consultation.
Table Of Contents
- Xigduo XR Lawsuit Overview
- Latest Xigduo XR Lawsuit Updates
- FDA Reports and Statistics
- Xigduo XR Injuries & Side Effects
- Do You Qualify for a Xigduo XR Lawsuit?
- Xigduo XR Recall Information
- Statute of Limitations for Xigduo XR Lawsuits
- FAQs
- 1. What is Xigduo XR and how does it work?
- 2. What are the warning signs of diabetic ketoacidosis (DKA)?
- 3. How serious are the side effects of Xigduo XR?
- 4. Can I still file a lawsuit if I’m currently taking Xigduo XR?
- 5. How much compensation can I expect from a Xigduo XR lawsuit?
- 6. Can I join a class action lawsuit for Xigduo XR?
- 7. What if my loved one died from complications related to Xigduo XR?
- 8. How long does a Xigduo XR lawsuit typically take?
- 9. What other diabetes drugs have similar risks to Xigduo XR?
- 10. What should I do if I’m experiencing side effects from Xigduo XR?
- Take Action Now: Time-Sensitive Legal Claims
- References
Xigduo XR Lawsuit Overview
Xigduo XR lawsuits target AstraZeneca for severe health complications allegedly caused by their diabetes medication.
Primary allegations include failure to adequately warn patients and doctors about serious risks including diabetic ketoacidosis (DKA), kidney failure, and other life-threatening conditions.
The FDA has received numerous adverse event reports involving Xigduo XR and similar SGLT2 inhibitor drugs, prompting multiple safety communications and label updates.
In 2017, federal lawsuits involving Xigduo XR were centralized in the Southern District of New York as multidistrict litigation (MDL).
Latest Xigduo XR Lawsuit Updates
March 2025 – Recent settlement discussions have advanced after scientific studies strengthened the causal connection between SGLT2 inhibitors and serious complications including Fournier’s gangrene, with affected patients potentially eligible for significant compensation [1].
November 2024 – The MDL judge expanded eligible claims to include additional kidney-related injuries after reviewing expert testimony establishing biological mechanisms through which Xigduo XR can damage renal function even at recommended dosages [2].
August 29, 2018 – FDA warned that SGLT2 inhibitor drugs like Xigduo XR have been linked to necrotizing fasciitis of the perineum (Fournier’s gangrene), a rare but serious infection of the genital area. At least a dozen patients required hospitalization and surgery, with one death reported [3].
June 14, 2016 – FDA issued a drug safety communication announcing upgraded warning labels for SGLT2 inhibitors including Xigduo XR (dapagliflozin) to include information about acute kidney injury and how to minimize the risk for it [4].
April 13, 2017 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered that all federal lawsuits involving Farxiga and Xigduo XR be centralized for pretrial handling in the Southern District of New York [5].
FDA Reports and Statistics
According to FDA adverse event reporting data and safety communications:
- From March 2013 to June 2014, at least 20 cases of ketoacidosis in patients treated with SGLT2 inhibitors were reported to the FDA
- Between March 2013 and October 2015, FDA received reports of 101 confirmed cases of acute kidney injury, some requiring hospitalization and dialysis
- By 2018, at least 12 cases of Fournier’s gangrene were linked to SGLT2 inhibitors, with all cases requiring hospitalization and surgery
- Since Xigduo XR’s approval in October 2014, hundreds of adverse events have been submitted to the FDA’s FAERS database
- The FDA has issued multiple safety communications about SGLT2 inhibitors in 2015, 2016, and 2018 [6]
Xigduo XR Injuries & Side Effects
Xigduo XR has been linked to numerous serious and potentially life-threatening complications that may warrant legal action.
- Diabetic Ketoacidosis (DKA): A dangerous condition where acids called ketones accumulate in the blood, potentially leading to diabetic coma or death
- Kidney Damage: Including acute kidney injury, kidney failure, kidney infections, and kidney stones requiring hospitalization or dialysis
- Fournier’s Gangrene: A rare but serious bacterial infection of the genital area requiring emergency surgery and extensive treatment
- Cardiovascular Issues: Including heart attacks, stroke, and other serious cardiovascular events
- Lactic Acidosis: A serious condition caused by buildup of lactic acid in the blood, which can be fatal
Xigduo XR combines dapagliflozin and metformin hydrochloride extended-release to help manage blood sugar levels in patients with type 2 diabetes mellitus.
In addition to Xigduo XR, other type 2 diabetes medications in the SGLT inhibitor class include:
- Invokamet (canagliflozin and metformin)
- Farxiga (dapagliflozin)
- Glyxambi (empagliflozin and linagliptin)
- Jardiance (empagliflozin)
Do You Qualify for a Xigduo XR Lawsuit?
You may qualify for a Xigduo XR lawsuit if:
- You were prescribed and took Xigduo XR for type 2 diabetes
- You experienced serious complications such as diabetic ketoacidosis, kidney failure, Fournier’s gangrene, or other severe side effects
- Your injuries required hospitalization, emergency treatment, or ongoing medical care
- You were not adequately warned about these potential risks before taking the medication
- Your complications occurred within a reasonable timeframe after taking Xigduo XR
Evidence Required for a Xigduo XR Lawsuit
- Medical records documenting your Xigduo XR prescription and duration of use
- Medical documentation of your diagnosis and treatment for DKA, kidney injury, or other complications
- Records of hospitalizations, surgeries, or other treatments related to your injuries
- Documentation showing a timeline connection between starting Xigduo XR and the onset of your condition
- Proof that you followed your doctor’s instructions regarding proper medication use
Damages You Can Recover
- Medical expenses for emergency treatment, hospitalization, surgeries, and ongoing care
- Lost wages and diminished earning capacity
- Pain and suffering compensation
- Costs for long-term care or disability accommodations
- Punitive damages in cases of manufacturer negligence
Xigduo XR Recall Information
As of 2025, no recall has been issued for Xigduo XR despite the numerous safety concerns and FDA warnings. The drug continues to be prescribed to diabetes patients nationwide with updated warning labels.
Instead of recalls, the FDA has opted to address safety concerns through:
- Multiple safety communications warning healthcare providers and patients about risks
- Label updates including a Black Box Warning about lactic acidosis (due to the metformin component)
- Enhanced warnings about ketoacidosis, kidney injury, and Fournier’s gangrene
- Recommendations for healthcare providers to monitor patients more closely [7]
Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. – FDA
Statute of Limitations for Xigduo XR Lawsuits
The statute of limitations for filing a Xigduo XR lawsuit varies by state but generally ranges from 1-3 years from the date of injury or discovery.
Several factors can affect these timelines:
- The “discovery rule” may extend the filing deadline to when you first discovered (or should have reasonably discovered) that Xigduo XR caused your injury
- Some states have specific statutes for pharmaceutical liability cases that differ from standard personal injury timeframes
- The MDL consolidation may affect certain procedural deadlines
- Minor children may have extended timeframes to file claims after reaching adulthood
Because of these complexities, it’s crucial to consult with an attorney as soon as possible to ensure your claim is filed within the appropriate timeframe [8].
FAQs
1. What is Xigduo XR and how does it work?
Xigduo XR combines dapagliflozin and metformin hydrochloride extended-release to manage blood sugar in type 2 diabetes patients. As an SGLT2 inhibitor, it works by allowing extra blood sugar to be removed through urine. It was approved by the FDA in October 2014.
2. What are the warning signs of diabetic ketoacidosis (DKA)?
Early symptoms include excessive thirst, frequent urination, high blood sugar, and high ketone levels in urine. Later symptoms include fatigue, dry or flushed skin, nausea, vomiting, abdominal pain, difficulty breathing, fruity-smelling breath, and confusion. Seek immediate medical attention if these symptoms occur.
3. How serious are the side effects of Xigduo XR?
Many Xigduo XR side effects can be life-threatening, including diabetic ketoacidosis, kidney failure, heart attacks, and Fournier’s gangrene. These conditions often require emergency hospitalization, surgery, or intensive treatment and may cause permanent damage or disability.
4. Can I still file a lawsuit if I’m currently taking Xigduo XR?
Yes, you can file a lawsuit even if you’re still taking the medication. However, never stop taking any prescribed medication without first consulting your healthcare provider about alternatives. Your medical needs should remain the priority while pursuing legal action.
5. How much compensation can I expect from a Xigduo XR lawsuit?
Compensation varies based on injury severity, medical expenses, lost income, and other damages. While some pharmaceutical cases have resulted in settlements ranging from tens of thousands to millions of dollars, each case is unique and evaluated individually.
6. Can I join a class action lawsuit for Xigduo XR?
Currently, Xigduo XR cases are being handled as individual lawsuits within a multidistrict litigation (MDL) rather than as a class action. This allows for individual assessment of damages while efficiently managing similar cases together. Your attorney can determine the best approach for your specific situation.
You may be eligible to file a wrongful death lawsuit if you’re the spouse, child, parent, or legal representative of someone who died due to Xigduo XR complications. These claims can seek compensation for medical expenses, funeral costs, lost support, and emotional suffering.
8. How long does a Xigduo XR lawsuit typically take?
The timeline varies significantly based on case complexity and whether it settles or goes to trial. MDL cases typically take 2-4 years to resolve, though some may settle earlier if strong evidence exists. Your attorney can provide more specific timeline estimates based on your situation.
9. What other diabetes drugs have similar risks to Xigduo XR?
Other SGLT2 inhibitors with similar risk profiles include Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Glyxambi (empagliflozin and linagliptin), and Jardiance (empagliflozin). If you’ve taken any of these medications and experienced complications, you might have grounds for a lawsuit.
10. What should I do if I’m experiencing side effects from Xigduo XR?
Seek immediate medical attention, especially for symptoms of ketoacidosis, kidney problems, or infection. Document all symptoms and treatments, keep all medication packaging, follow your doctor’s advice, report side effects to the FDA’s MedWatch program, and consult with an attorney about your legal options.
See all related dangerous drugs lawsuits our attorneys covered so far.
Take Action Now: Time-Sensitive Legal Claims
Time is limited to pursue legal action for Xigduo XR injuries. Most states allow only 1-3 years from the date of injury or discovery to file a claim, and this window may be closing rapidly in your case.
Our legal team at Schmidt & Clark, LLP offers:
- Free, confidential case evaluations
- No upfront costs or attorney fees
- Payment only if we win your case
Don’t delay taking action that could secure the compensation you deserve. Contact us today to protect your legal rights.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by the side effects of Xigduo XR, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and we can help.
References
1. https://www.reuters.com/legal/litigation/sglt2-settlement-talks
2. https://www.uscourts.gov/sglt2-litigation-update
3. https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm446852.htm
4. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-strengthens-kidney-warnings-diabetes-medicines-canagliflozin
5. https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2776-Initial_Transfer-04-17.pdf
6. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/
7. https://www.fda.gov/Drugs/DrugSafety/ucm505860.htm
8. https://www.law.cornell.edu/wex/statute_of_limitations