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Ketoacidosis, Acute Kidney Injury, Kidney Failure, Heart Attacks, Strokes, DVT / PE, and Other Side Effects Linked to These Diabetes Drugs
UPDATE: On June 14, 2016 the FDA announced it has strengthened the existing warning about the risk of acute kidney injury for Invokana and Invokamet as well as Farxiga and Xigduo XR. Based on recent reports, the side effets warnings in the drug labels have been revised to include more exact information about acute kidney injury.
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
Invokana Has New Warning About Risk Of Lower Limb Amputation In Canada
We continue to monitor the drug safety regulators as well as the medical literature concerning the possible link between an increased risk of these amputations and the use of SGLT2 inhibitors such as Invokana, Invokamet, Farxiga, Xigduo XR, and Jardiance.
From the Health Product InfoWatch newsletter — formerly The Canadian Adverse Reaction Newsletter (CARN) — put out by Health Canada in December 2016, under the “Product monograph updates” heading, we get this drug safety development:
Invokana (canagliflozin) and Invokamet (canagliflozin and metformin hydrochloride)
The risk of lower limb amputation, primarily of the toe, has been added to the Adverse Reactions section of the Canadian product monographs for Invokana (canagliflozin) and Invokamet (canagliflozin and metformin hydrochloride).
As background, from this July 2016 Medscape Medical News report, “EMA Extends Amputation Investigation to All SGLT2 Inhibitors” (free registration required to access article):
The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has extended the scope of its investigation into the possible link between the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Vokanamet, Janssen) and amputations to include other drugs of the same class.
Now, the PRAC’s review will include the other SGLT2 inhibitor medicines dapagliflozin (Farxiga, Xigduo XR, AstraZeneca), and empagliflozin (Jardiance, Boehringer Ingelheim), based on the determination that the potential risk may be relevant for them as well.
And back in mid-May 2016 there was this item, “FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate”.
Since then, we have not heard again from the FDA about the results of this investigation regarding leg, foot, and toe amputations possibly caused by the use of Invokana and Invokamet.
- 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