The U.S. Food & Drug Administration (FDA) has issued a warning about an increased risk of foot, leg and toe amputations associated with canagliflozin, a type 2 diabetes medication sold under the brand names Invokana and Invokamet.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: Invokana Linked to Doubled Risk of Amputation, Study Finds
July 13, 2017 – Diabetes patients who take Invokana had a doubled risk for amputations of the toes or feet compared to patients who took a placebo, according to a study presented last month at the annual meeting of the American Diabetes Association (ADA). The drug was, however, found to the reduce risk of hospitalization for heart failure and protect against kidney function decline.
What’s the Problem?
May 18, 2016 – The FDA warning was issued in response to the results of an ongoing trial known as Canagliflozin Cardiovascular Assessment Study (CANVAS), which is expected to be completed next year. Preliminary findings from the study indicate that type 2 diabetics who took canagliflozin were more likely to require a leg, foot or toe amputation compared to patients who took other types of drugs. Although the agency acknowledged that additional studies are needed to determine whether canagliflozin is responsible for the increased amputation risk, it nevertheless advised patients to seek immediate medical attention if they experience the following symptoms in their legs or feet:
FDA also cautioned that diabetes patients should never switch or quit taking a medication without consulting their physician first, as doing so could lead to uncontrolled blood sugar levels, blindness, nerve / kidney damage, and heart disease.
EMA Requests Data on Invokana Amputations
In response to the FDA warning on canagliflozin, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has asked Janssen for more information about the amputation risk associated with Invokana, and whether any changes to the way the med is used should be made in the EU, according to Medscape.
Invokana Side Effects
In addition to the increased risk of amputation, Invokana and Invokamet have also previously been linked to other serious side effects including:
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Ketoacidosis, Ketoacidosis)
- Heart Attack (Myocardial Infarction or MI)
- Kidney Failure (Renal Failure) / Kidney Cancer / Kidney Infections (Pyelonephritis) / Kidney Stones
- Bone Fractures / Bone Abnormalities
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
- Yeast Infections (both men and women)
FDA Requires Boxed Warning on Amputation Risk with Invokana
May 16, 2017 – Based on the final results of 2 long-term clinical trials, FDA has concluded that type 2 diabetes patients who take Invokana or Invokamet are twice as likely to have their foot or toe amputated. As a result of these findings, the agency is requiring that both medications carry a boxed warning regarding the amputation risk.
Do I Have an Invokana Amputation Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokana lawsuits. We are handling individual litigation nationwide and currently accepting new amputation cases in all 50 states.
Free Confidential Case Evaluation: Again, if you had a body part amputated after using Invokana or Invokamet, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.