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Ketoacidosis, Acute Kidney Injury, Kidney Failure, Heart Attacks, Strokes, DVT / PE, and Other Side Effects Linked to These Diabetes Drugs
The FDA is investigating a connection between Invokana, Farxiga, and Jardiance, as well as Invokamet, Xigduo, Glyxambi, and Synjardy, with these various medical complications as drug side effects:
Diabetic Ketoacidosis (DKA)
Acute Kidney Injury
Kidney Failure / Renal Failure
Pyelonephritis (kidney infection)
Urosepsis (blood infection)
Urinary Tract Infection (UTI)
Heart Attacks / Myocardial Infarctions (MI)
Ischemic Stroke / Cerebral Vascular Accident (CVA)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Foot or Toe(s) Amputation
All of these diabetes drugs are Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors, a new class of diabetes medicines.
As regards the ketoacidosis side effects, it is important to know that if diabetic ketoacidosis (DKA) is not treated, it can lead to severe illness or death. In more detail, possible complications of DKA include these medical conditions:
- Cerebral Edema (fluid buildup in the brain)
- Bowel Necrosis (death of bowel tissue due to low blood pressure)
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients who have developed any of the medical conditions listed above. For example:
Jardiance – Diabetic Ketoacidoisis (DKA) – 60 yr old woman
Invokana – Acute Kidney Disease – 46 yr old man
Jardiance – Diabetic Ketoacidosis (DKA) – 60 yr old woman
Farxiga – Liver Failure and Transplant; Renal Failure – 48 yr old woman
Farxiga – Diabetic Ketoacidosis (DKA) – 27 yr old woman
Jardiance – Stroke – 60 yr old woman
Farxiga – Heart Failure – 64 yr old man
Invokana – Heart Attack – 69 yr old man
Farxiga – Acute Renal Failure – 56 yr old woman
Farxiga / Xigduo XR – Diabetic Ketoacidosis (DKA) – 38 yr old man
We encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.
List of Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors Currently Available in the US
Invokana (canagliflozin) — Janssen Pharmaceuticals — FDA Approval: 2013
Invokamet (canagliflozin and metformin) — Janssen Pharmaceuticals — FDA Approval: 2014
Invokamet XR (canagliflozin and metformin extended-release) — Janssen Pharmaceuticals — FDA Approval: 2016
Farxiga (dapagliflozin) — AstraZeneca Pharmaceuticals — FDA Approval: 2014
Xigduo XR (dapagliflozin and metformin extended-release) — AstraZeneca Pharmaceuticals — FDA Approval: 2014
Jardiance (empagliflozin) — Boehringer Ingelheim Pharmaceuticals — FDA Approval: 2014
Glyxambi (empagliflozin and linagliptin) — Boehringer Ingelheim Pharmaceuticals — FDA Approval: 2015
Synjardy (empagliflozin and metformin hydrochloride) — Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company — FDA Approval: 2015
Synjardy XR (empagliflozin and metformin hydrochloride) — Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company — FDA Approval: 2016
Federal Court Invokana MDL In New Jersey With Judge Brian Martinotti
Invokana (canagliflozin) was approved by the FDA in 2013. Invokamet (canagliflozin and metformin) was approved by the FDA in 2014. Both of these drugs were approved for use by patients with Type 2 diabetes.
In December 2015 the FDA issued this 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”. In part, it warned about the risk of ketoacidosis, a serious medical condition caused by having too much acid in the blood, for Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors, a class of newer diabetes drugs which include Invokana and Invokamet.
In May and June 2016 the FDA announced it had strengthened the existing warning about the risk of acute kidney injury for Invokana and Invokamet.
In August 2016 the FDA sent letters to Janssen for Invokana and Invokamet label changes concerning fatal cases of ketoacidosis.
Due in part to these FDA drug safety alerts, there have been lawsuits filed on behalf of diabetes patients who used Invokana or Invokamet. Those lawsuits recently gave rise to a request for the consolidation of all Invokana and Invokamet cases pending in the various federal court districts around the country before one judge.
In September 2016, pursuant to 28 U.S.C. § 1407, a motion was filed to establish IN RE: INVOKANA (CANAGLIFLOZIN) PRODUCTS LIABILITY LITIGATION, MDL Docket No. 2750.
In October 2016 the attorneys for Defendant Janssen Pharmaceuticals, Inc. (“Janssen”) indicated, in their legal document filed as a response to this MDL motion, it agreed that all Invokana cases filed in the federal court system should be consolidated. Further, they agreed that federal Judge Brian Martinotti, of the District of New Jersey, would be an appropriate choice by the Judicial Panel for Multidistrict Litigation (JPML) for the so-called “transferee judge” presiding over this Invokana MDL.
In December 2016 the JPML issued an Order establishing this consolidation of all Invokana and Invokamet federal court lawsuits.
We are currently investigating possible Invokamet and Invokana lawsuits against the drug company Janssen for diabetes patients who have developed any of the medical conditions listed above.
Of course, we will continue to monitor the Invokana / Invokamet legal cases and report significant developments here.
- New Federal Court Multidistrict Litigation (MDL) For Farxiga Lawsuits
- Invokana Has New Warning About Risk Of Lower Limb Amputation In Canada
- December 2016: FDA Requires Safety Warnings Label Change For Jardiance
- Farxiga / Jardiance / Invokana: Label Change Adds Ketoacidosis Warning
- Invokana / Farxiga / Jardiance: UTIs Then Urosepsis And Pyelonephritis
- Invokana / Farxiga / Jardiance: Amputations; Lactic Acidosis; Ketoacidosis
- FDA: Acute Kidney Injury Due To Invokana, Invokamet, Farxiga, Xigduo
- Stroke, DVT, Pulmonary Embolism, And Kidney Damage Linked To Invokana
- When Used By Type 1 Diabetes Patients, Invokana Can Cause Ketoacidosis
- Invokana Cases Involving Diabetic Ketoacidosis And Kidney Side Effects
- EMA Says Invokana / Farxiga /Jardiance Linked To Diabetic Ketoacidosis
- FDA Adds New Ketoacidosis Side Effect Warnings To Invokana Drug Label
- Invokana Label Gets New Warnings About Increased Bone Fracture Risks
- Despite Benefits Of Jardiance, There Are Still Safety Concerns
- Invokana Lawsuits Filed While FDA Investigates Side Effects Reports
- Farxiga / Jardiance / Invokana: Ketoacidosis and Kidney Failure
- Invokana / Farxiga / Jardiance: New Medical Study Finds A History Of Diabetic Ketoacidosis Events Is Associated With Increased Risk of Death
- May 2015 Diabetes Drugs – Ketoacidosis Link Warning By FDA Covers Invokana, Farxiga, And Jardiance, With Label Changes Possible
All content by attorney Tom Lamb