Farxiga Diabetes Drug | Lawsuit & Complications

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Bristol-Myers Squibb first received U.S. Food and Drug Administration (FDA) approval for Farxiga (dapagliflozin) on January 8, 2014.⁽¹⁾

Less than a month later, AstraZeneca acquired the company’s diabetes drug portfolio, including ownership of and the rights to Farxiga.⁽²⁾ In October 2014, the FDA approved AstraZeneca’s Xigduo XR – which combines Farxiga with the diabetes drug metformin in an extended-released formulation.⁽³⁾

Farxiga quickly became AstraZeneca’s largest selling diabetes medicine, recording $492 million in global sales in 2015.

Farxiga quickly became AstraZeneca’s largest selling diabetes medicine,⁽⁴⁾ recording $492 million in global sales in 2015.⁽⁵⁾

But by then, Farxiga and other drugs in this class were linked to serious medical conditions that can lead to hospitalization, dialysis, or death.

Farxiga Linked to Medical Complications

Both Farxiga and its sister drug, Xigduo XR, have become subjects of regulatory scrutiny as these and other SGLT2 inhibitors have been linked with serious medical complications.

These conditions include:

Diabetic ketoacidosis (DKA) – a condition involving too much acid in the blood that can result in coma or death⁽⁶⁾
Acute kidney injury (AKI)⁽⁷⁾
Serious urinary tract infections (UTIs) resulting in blood or kidney infections (urosepsis and pyelonephritis)⁽⁸⁾

If you have developed any of these conditions after taking Farxiga or Xigduo XR, or if a relative died from one of these conditions after taking these drugs, you may be entitled to reimbursement for medical expenses, lost wages, and other costs.

Attorneys with Weitz & Luxenberg’s Drug and Medical Device Unit have played key roles in securing billions of dollars in verdicts and settlements for people hurt by faulty medicines and medical devices. While past results are no guarantee of future success, Weitz & Luxenberg has the experience and resources necessary to pursue justice for clients in complex health-related legal cases.

Farxiga Faces Government Scrutiny

The FDA originally denied approval for Farxiga in 2012, citing clinical trials with potentially problematic findings regarding cardiovascular, liver, and cancer risks. The agency required additional trials be submitted before reconsidering the application and subsequently approved the drug two years later.⁽⁹⁾

“identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections” in patients taking SGLT2 inhibitors.

In May 2015, the FDA warned that Farxiga and other SGLT2 inhibitors may lead to diabetic ketoacidosis (DKA), a serious condition involving elevated blood acid levels that can require hospitalization.⁽¹⁰⁾

In December 2015, the FDA said it had “identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections” in patients taking SGLT2 inhibitors.⁽¹¹⁾ The agency ordered manufacturers of Farxiga and other drugs in its class to revise label warnings reflecting possible risks of DKA and serious urinary tract infections that can result in hospitalization.

On June 14, 2016, the FDA further strengthened the warnings for Farxiga, Xigduo XR, and other SGLT2 inhibitors “to include information about acute kidney injury.” The agency also urged doctors and patients to report adverse side effects of Farxiga, Xigduo XR, and other SGLT2 inhibitors to the FDA MedWatch program.⁽¹²⁾

In late 2016, the FDA again identified a potential signal of serious risk requiring an evaluation of the need for regulatory action for Farxiga and other drugs in its class following reports of patients taking Farxiga and other SGLT2 inhibitors who developed acute pancreatitis.⁽¹³⁾ The condition is fatal for roughly 10% of people who develop it.⁽¹⁴⁾

In February 2017, the European Medicines Agency (EMA) concluded that another SGLT2 inhibitor, canagliflozin, may lead to lower limb amputations – particularly toes. The EMA announcement said the risk had not been seen in studies involving other SGLT2 inhibitors, including Farxiga, but “data available to date are limited and the risk may also apply to these other medicines.” The EMA is currently monitoring other studies that could define any possible risk of amputations for Farxiga and other types of SGLT2 inhibitor users.⁽¹⁵⁾

If you have been injured after taking Farxiga or Xigduo XR, speaking with a knowledgeable attorney can help you understand your legal options. Weitz & Luxenberg can provide you with a free consultation.

Farxiga and Diabetic Ketoacidosis (DKA)

Farxiga and other SGLT2 inhibitors have been linked with risk of a patient developing DKA, which can result in a diabetic coma or death.⁽¹⁶⁾ DKA is a condition in which excess acid levels build up in the blood.

The FDA has warned patients taking Farxiga, Xigduo XR, and other SGLT2 inhibitors to not take their medicine and seek immediate medical attention if they experience symptoms of DKA.

These symptoms include:⁽¹⁷⁾

Difficulty breathing
Abdominal pain
Nausea or vomiting
Unusual fatigue or sleepiness

Consult your doctor before stopping any prescribed medication.

If you were hospitalized for diabetic ketoacidosis, blood or kidney infections resulting from a UTI, or acute kidney injury after taking Farxiga or Xigduo XR for type 2 diabetes, Weitz & Luxenberg would like to hear from you.

Weitz & Luxenberg would also like to talk to people who suffered renal failure after taking Farxiga or Xigduo XR.

Farxiga Lawsuits & MDL

In multiple lawsuits against Bristol-Myers Squibb and AstraZeneca, plaintiffs allege they developed ketoacidosis after taking Farxiga.

Complaints filed in New York federal court claim the companies were “aware of the potential for FARXIGA and other drugs in the SGLT-2 inhibitor class to cause kidney failure prior to FARXIGA’s approval,”^{(18) (19)} but failed to adequately warn patients of the risks.

In February 2017, plaintiffs asked the Judicial Panel on Multidistrict Litigation to combine lawsuits over Farxiga into a multidistrict litigation.

On July 13, 2017, Ellen Relkin, Esq. of Weitz & Luxenberg was appointed by the Honorable Lorna G. Schofield as Co-Lead Counsel and Danielle Gold, Esq. of Weitz & Luxenberg was appointed as Plaintiffs’ Liaison Counsel in the In Re: Farxiga (Dapagliflozin) Products Liability Litigation Multidistrict Litigation venued in the Southern District of New York. In these two key roles, Weitz &Luxenberg is in the forefront of the leadership of this litigation.

MDLs speed up the legal process and save time and money by consolidating cases for pretrial discovery and other pretrial proceedings.

How Weitz & Luxenberg Can Help

You may be entitled to compensation if you took Farxiga or Xigduo XR and were then hospitalized for DKA, acute kidney injury (AKI), renal failure, or for a urinary tract infection that resulted in a blood or kidney infection. You may also be entitled to compensation if a relative died after taking Farxiga after suffering from DKA, AKI or renal failure, or a urinary tract infection resulting in a blood or kidney infection.

We can help you determine your legal options, beginning with a free consultation.

Contact Weitz & Luxenberg at , or fill out the contact form on this page and one of our representatives will be in touch with you shortly.

View Sources

FDA.gov. (2014, January 8). NDA 202293; NDA Approval Letter (Farxiga). Retrieved from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s000ltr.pdf
AstraZeneca.com. (2014, February 3). AstraZeneca completes the acquisition of Bristol-Myers Squibb share of global diabetes alliance. Retrieved from https://www.astrazeneca.com/media-centre/press-releases/2014/astrazeneca-aquisition-bristol-myers-squibb-global-diabetes-alliance-03022014.html#
FDA.gov. (2014, October 29). Center for Drug Evaluation and Research; Approval Package for Xigduo XR. Retrieved from http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000Approv.pdf
AstraZeneca.com. (2016, November 10). Year-To-Date and Q3 2016 Results (pg. 1). Retrieved from https://www.astrazeneca.com/content/dam/az/PDF/20161110-Q3_2016_Rslts_prss-FINAL_v2.pdf
AstraZeneca.com. (2016). What science can do; AstraZeneca Annual Report and Form 20-F Information 2015; Return to Growth; Diabetes (pg. 19). Retrieved from https://www.astrazeneca.com/content/dam/az/Investor_Relations/Annual-report-2015/AZ_Annual_Report_2015(1).pdf
FDA.gov. (2015, December 4). FDA Drug Safety Communication: FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm475463.htm
FDA.gov. (2016, June 14). Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm
FDA.gov. (2015, December 4). FDA Drug Safety Communication: FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm475463.htm
FDA.gov. (2012, January 17). Complete Response Letter; NDA 202293. Retrieved from http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM378077.pdf
FDA.gov. (2015, May 15). FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm
FDA.gov. (2015, December 4). FDA Drug Safety Communication: FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm475463.htm
FDA.gov. (2016, June 14). Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm
FDA.gov. (2016, October 5). Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) List from April to June 2016. Retrieved from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm523358.htm
National Pancreas Foundation. (n.d.). About Acute Pancreatitis. Retrieved from https://www.pancreasfoundation.org/patient-information/acute-pancreatitis/
European Medicines Agency. (2017, February 10). PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation; Risk may also apply to other medicines in the same class. Retrieved from http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/SGLT2_inhibitors_Canagliflozin_20/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee/WC500221431.pdf
American Diabetes Association. (2015, March 18). DKA (Ketoacidosis) & Ketones. Retrieved from http://www.diabetes.org/living-with-diabetes/complications/ketoacidosis-dka.html
FDA.gov. (2015, December 4). FDA Drug Safety Communication: FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm475463.htm
U.S. District Court, S.D. New York. (2016, December 16). Collins v. Bristol-Myers Squibb Co., AstraZeneca LP, and AstraZeneca Pharmaceuticals LP.
U.S. District Court, S.D. New York. (2016, December 20). Cormier v. Bristol-Myers Squibb Co., AstraZeneca LP, and AstraZeneca Pharmaceuticals LP.

Farxiga Diabetes Drug Linked to Complications