Invokana Linked to Serious Side Effects

In 2015, just two years after Invokana received FDA approval, government agencies in the U.S., Canada, and the European Union began issuing a series of warnings and advisories about risks associated with Invokana and other drugs in its class.
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Janssen Pharmaceuticals’ Invokana (canagliflozin) was approved by the U.S. Food and Drug Administration (FDA) in 2013. As the first in a new class of diabetes drugs called active inhibitors of sodium-glucose co-transporter-2 (SGLT2), Invokana is intended to treat type 2 diabetes, along with diet and exercise.

Invokana is thought to work by blocking glucose reabsorption into the bloodstream, thereby increasing urinary glucose excretion, and, in turn, lowering blood sugar levels in persons with elevated blood sugar concentrations. However, Invokana and SGLT2 inhibitors have been linked with serious medical conditions that could result in hospitalization or even death.

Complications Associated with Invokana and the SGLT2 Inhibitors

In 2014, Janssen Pharmaceuticals received FDA approval for another SGLT2 inhibitor, Invokamet, which combines Invokana and another type 2 diabetes drug, metformin. Together, Invokana and Invokamet accounted for more than $1.3 billion in Janssen worldwide sales in 2015.

But Invokana, Invokamet, and the other SGLT2 inhibitors have been the subject of attention from government agencies in the U.S., Canada, Europe, and other countries because of 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
  • Serious urinary tract infections (UTIs) resulting in blood or kidney infections
  • Acute kidney injury (AKI)
  • Increased risk of leg and foot amputations (Invokana and Invokamet)
  • Stroke and thromboembolic events

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

For a free consultation and more information about your legal options, please contact us today.

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Ellen Relkin, of Weitz & Luxenberg’s Drug and Medical Device Unit was appointed by the Honorable Brian Martinotti, the Judge handling the entire multidistrict litigation (MDL), to serve on the Plaintiffs’ Executive Committee. In that role, Weitz & Luxenberg is serving in the leadership of the litigation.

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 or medical devices. While past results are not a guarantee of future success, Weitz & Luxenberg has the experience and resources necessary to pursue justice for clients in complex medical-related cases.

Invokana and SGLT2 Inhibitors Face Government Scrutiny

In 2015, just two years after Invokana received FDA approval, government agencies in the U.S., Canada, and the European Union began issuing a series of warnings and advisories about risks associated with Invokana and other drugs in its class.

  • In May 2015, the FDA warned that Invokana and other SGLT2 inhibitors may lead to diabetic ketoacidosis, a serious condition that can require hospitalization. The FDA’s Canadian counterpart, Health Canada, issued a similar report in May 2016.
  • In January 2016, the FDA made public it had detected a potential signal of a serious risk of stroke or serious blood clots with the use of Invokana and other drugs in its class. The agency noted it was “evaluating the need for regulatory action” after receiving a significant number of reports to the FDA Adverse Event Reporting System (FAERS).
  • On May 18, 2016, FDA issued a Drug Safety Communication warning the public about interim safety results from “an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes,” in patients who had taken Invokana or Invokamet.
  • On June 14, 2016, the FDA further strengthened the warnings for Invokana, Invokamet, and another type of SGLT2 inhibitor “to include information about acute kidney injury…” The agency also called on health care professionals and patients to report Invokana and other SGLT2 inhibitor side effects to the FDA MedWatch program.
  • In late 2016, the FDA said it was “evaluating the need for regulatory action” after detecting a potential signal of serious risk of acute pancreatitis via adverse events reported to the FDA; that patients taking Invokana and other SGLT2 inhibitors had developed this condition. Previous studies published in 2015 had warned that drug-induced pancreatitis (DIP) “may easily be overlooked” in patients taking Invokana, and doctors should be aware of the “potentially fatal adverse effect” as Invokana is more widely prescribed.
  • In February 2017, the European Medicines Agency (EMA) concluded its investigation of leg and foot amputations. The agency recommended that a warning on the risk of lower limb amputations – primarily toes – be included with prescribing information for SGLT2 inhibitors.
  • On May 16, 2017, the FDA determined that “Based on new data from two large clinical trials . . . the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.”

If you have been injured after taking Invokana and Invokamet, Weitz & Luxenberg can provide a free consultation to help you understand your legal options.

We would feel privileged to assist you. For a free consultation and more information about your legal options, please contact us today.
(877) 566-0055

Invokana and Other SGLT2 Inhibitor-Induced Diabetic Ketoacidosis (DKA)

One of Invokana’s and the other SGLT2 inhibitors’ most widely studied adverse events is that of their relationship with diabetic ketoacidosis. Multiple studies have demonstrated patients taking Invokana or other SGLT2 inhibitors may develop DKA. Diabetic ketoacidosis results from too much acid in the blood. In severe cases, DKA can result in a diabetic coma or death.

The FDA has mandated the addition of a warning to the Invokana and other SGLT2 inhibitors’ labels regarding the risk of diabetic ketoacidosis.

The warning informs patients to seek immediate medical attention if they experience symptoms of DKA, which may include:

  • Difficulty breathing
  • Nausea or vomiting
  • Abdominal pain
  • Unusual fatigue or sleepiness
  • Confusion
  • Abdominal pain

If you were prescribed Invokana or another SGLT2 inhibitor for type 2 diabetes and were later hospitalized for diabetic ketoacidosis, Weitz and Luxenberg would like to talk to you.

Invokana and Other Injuries

Weitz & Luxenberg is also interested in talking to adult patients who took Invokana or Invokamet and had to be hospitalized due to a urinary tract infection resulting in a blood or kidney infection, acute kidney injury, or renal failure.

In addition, if you or a loved one suffered a heart attack or stroke while on Invokana or Invokamet, or shortly after stopping these medicines, Weitz & Luxenberg may be able to help. Consult your doctor before stopping any prescribed medication.

Invokana Lawsuits Filed

Multiple lawsuits claim Janssen Pharmaceuticals was aware of potential dangers, but never warned patients about the risk of kidney damage or other complications.

In December 2016, 55 lawsuits over Invokana were combined into a single multidistrict litigation (MDL) in New Jersey.

In December 2016, 55 lawsuits over Invokana were combined into a single multidistrict litigation (MDL) in New Jersey. There are now several hundred cases pending. Weitz & Luxenberg has also filed claims in the New Jersey Superior Court. MDLs speed up the legal process and save time and money by consolidating all cases for discovery and selecting a small number of cases to be tried as bellwether cases. Since that time, many more cases have joined the MDL, and other lawsuits are expected to be included in the MDL in the future.

How Weitz & Luxenberg Can Help

You may be entitled to compensation if you took Invokana or another SGLT2 inhibitor and were then hospitalized for DKA, acute kidney injury, or for a serious urinary tract infection that resulted in a blood or kidney infection. You may also be entitled to compensation if a relative died after taking Invokana or another SGLT2 inhibitor.

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

Contact Weitz & Luxenberg at (877) 566-0055, or fill out the contact form on this page and one of our representatives will be in touch with you shortly.

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  2. U.S. Food and Drug Administration. (2015, December 4). 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
  3. Health Canada. (2015, October 16). Summary Safety Review – Sodium Glucose Cotransporter 2 (SGLT2) Inhibitors INVOKANA (canagliflozin) and FORXIGA (dapagliflozin) – Evaluation of a Potential Risk of Acute Kidney Injury. Retrieved from http://www.hc-sc.gc.ca/dhp-mps/medeff/reviews-examens/sglt2-eng.php
  4. European Medicines Agency (EMA). (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
  5. U.S. Food and Drug Administration. (2015, December 4). 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
  6. U.S. Food and Drug Administration. (2015, December 4). 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
  7. U.S. Food and Drug Administration. (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
  8. U.S. Food and Drug Administration. (2016, May 18). Canagliflozin (Invokana, Invokamet): Drug Safety Communication – Clinical Trial Results Find Increased Risk of Leg and Foot Amputations. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm501565.htm
  9. U.S. Food and Drug Administration. (2016, August 2). Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between April – June 2015. Retrieved from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm484292.htm
  10. U.S. Food and Drug Administration. (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
  11. Health Canada. (2016, May 16). Summary Safety Review – SGLT2 Inhibitors (canagliflozin, dapagliflozin, empagliflozin) – Assessing the Risk of the Body Producing High Levels of Acids in the Blood (diabetic ketoacidosis) Retrieved from http://www.hc-sc.gc.ca/dhp-mps/medeff/reviews-examens/sglt2-2-eng.php
  12. U.S. Food and Drug Administration. (2016, August 2). Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between April – June 2015. Retrieved from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm484292.htm
  13. U.S. Food and Drug Administration. (2016, May 18). Canagliflozin (Invokana, Invokamet): Drug Safety Communication – Clinical Trial Results Find Increased Risk of Leg and Foot Amputations. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm501565.htm
  14. U.S. Food and Drug Administration. (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
  15. U.S. Food and Drug Administration. (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
  16. Chowdhary, M., et al. (2015, June 26). Canagliflozin-induced pancreatitis: rare side effect of a new drug. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4489815/
  17. Srivali, N., et al. (2015, June - August). Acute Pancreatitis in the use of canagliflozin: A rare side-effect of the novel therapy for type 2 diabetes mellitus. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4513334
  18. European Medicines Agency (EMA). (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
  19. U.S. Food and Drug Administration. (2017, May 16). Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations. Retrieved from https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm558605.htm
  20. Gelaye, A., et al. (2016, March 21). Severe Ketoacidosis Associated with Canagliflozin (Invokana): A Safety Concern. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4819091/
  21. Peters, A.L, et al. (2015, September). Euglycemic Diabetic Ketoacidosis: A Potential Complication of Treatment with Sodium-Glucose Cotransporter 2 Inhibition. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/26078479
  22. Taylor, S.I., et al. (2015, June 18). SGLT2 Inhibitors May Predispose to Ketoacidosis. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4525004/
  23. American Diabetes Association. (2015, March 18). DKA (Ketoacidosis) & Ketones. Retrieved from http://www.diabetes.org/living-with-diabetes/complications/ketoacidosis-dka.html
  24. U.S. Food and Drug Administration. (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
  25. U.S. Food and Drug Administration. (2015, December 4). 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 https://www.fda.gov/Drugs/DrugSafety/ucm475463.htm
  26. U.S. District Court, District of New Jersey, Trenton Division. (2015, November 13). Puente et al. v. Janssen Pharmaceuticals, Inc., et al.
  27. U.S. Judicial Panel on Multidistrict Litigation. (2016, December 7). In re: Invokana (Canagliflozin) Products Liability Litigation. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2750-Initial_Transfer-12-16.pdf

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