In a rush? You can use our Quick Contact Form to tell us the basic information about your case.
Ketoacidosis, Kidney Failure, and Lower Limb Amputations are Some of the Side Effects Linked to These Diabetes Drugs
The FDA is investigating a connection between Invokana, Farxiga, and Jardiance, as well as Invokamet, Xigduo, Glyxambi, Synjardy, and Qtern with these various medical complications as drug side effects:
- Diabetic Ketoacidosis (DKA)
- Leg Amputation
- Foot or Toe(s) Amputation
- Acute Kidney Injury
- Kidney Failure / Renal Failure
- Kidney Damage
- Pyelonephritis (kidney infection)
- Urosepsis (blood infection)
- Urinary Tract Infection (UTI)
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:
Farxiga– Lower Limb Amputations – 45 yr old man
Farxiga – Diabetic Ketoacidosis (DKA) – 46 yr old woman
Jardiance – Amputation of Leg (right) to Knee; Amputation of Foot (left) – 63 yr old man
Invokana – Foot Amputation – 52 yr old man
Jardiance – Diabetic Ketoacidosis (DKA) – 51 yr old woman
Glyxambi – Diabetic Ketoacidosis (DKA) – 54 yr old man
Jardiance – Diabetic Ketoacidoisis (DKA) – 60 yr old woman
Invokana – Acute Kidney Disease – 46 yr old man
Jardiance – Diabetic Ketoacidosis (DKA) – 60 yr old woman
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
Qtern (dapagliflozin and saxagliptin) AstraZeneca Pharmaceuticals — FDA Approval: 2017
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
In September 2017 Health Canada required Janssen, the drug company responsible for Invokana and Invokamet, to send a Dear Healthcare Professional Letter — commonly referred to as a “Dear Doctor” letter — about the lower limb amputations side effect.
Here are some of the points presented in this September 2017 Janssen letter to Canadian healthcare professionals:
- Carefully monitor patients with risk factors for amputation events, e.g., patients with previous amputations, existing peripheral vascular disease or neuropathy.
- Advise patients to notify their healthcare provider if they develop sores, ulceration, discoloration, infection, new lower extremity pain or tenderness.
- Initiate early treatment for foot problems for, but not limited to, ulceration, infection, new pain or tenderness.
- Discontinue canagliflozin treatment in patients who develop a significant complication, such as a lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
To our knowledge, no such “Dear Doctor” letter has been sent out in the US, yet. If you know otherwise, however, you can let us know by submitting a Comment below or sending an email to me.
Up in Canada, it was back in October 2016 that the Product Monographs for Invokana and Invokamet were updated to include a warning about the risk of toes, foot, and leg amputations. This action was based on interim results of the Canagliflozin Cardiovascular Assessment Study (CANVAS) study.
We will continue to monitor this risk of lower limb amputations for Invokana and Invokamet as well as watch to whether this adverse reaction also involves other diabetes medicines in this SGLT2 class of drugs, such as Farxiga and Jardiance.
Earlier Invokana / Farxiga / Jardiance articles by attorney Tom Lamb on the Side Effects Blog:
- FDA Reports Show Extent And Nature of Invokana-Amputation Side Effect
- Invokana Gets “Black-Box Warning” For Risk Of Leg And Foot Amputations
- Jardiance, Invokana, And Farxiga Double Risk Of Diabetic Ketoacidosis
- Farxiga MDL Includes Diabetic Ketoacidosis And Kidney Damage Lawsuits
- Federal Court Invokana MDL In New Jersey With Judge Brian Martinotti
- 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