The type 2 diabetes medication Invokana (generic: canagliflozin) has been linked to an increased risk for amputations of the leg, foot and toes, according to the U.S. Food & Drug Administration (FDA).
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: 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.
What’s the Problem?
May 18, 2016 – FDA today issued a Drug Safety Alert in response to an interim analysis of the Canagliflozin Cardiovascular Assessment Study (CANVAS), which found an approximately 2-fold increased risk of leg and foot amputations in patients treated with canagliflozin (the active ingredient in Invokana and Invokamet) compared to patients who took a placebo. Specifically, the study indicated that the rate of amputations per every 1000 patients was equivalent to 7 for 100 mg/day and 5 for 300 mg/day of canagliflozin compared with 3 per 1000 patients taking placebo.
The agency has not yet determined whether canagliflozin actually increases the risk for amputations and is investigating further. Healthcare professionals are advised to follow the recommendations in Invokana and Invokamet drug labels and monitor patients for signs and symptoms of foot problems, which may include:
How Can Invokana Cause Amputations?
Although the link between canagliflozin and amputations was only recently uncovered and is still not fully understood, it is known that diabetes causes blood vessels of the lower extremities to narrow and harden, which decreases circulation and increases the risk of amputation. Invokana might further increase the risk of amputation because it is a diuretic – excess urination can lower the amount of fluid in the body, which can cause circulation problems.
Canagliflozin Under Scrutiny in Europe
In response to the FDA’s warning on canagliflozin, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has requested additional information from Janssen regarding the amputation risk, and asked whether any changes to the way the drug is used in the European Union (EU). The CANVAS study is scheduled to be completed next year.
Do I Have an Invokana Amputation Lawsuit?
The Class Action 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 were forced to have a foot, leg or toe amputated after taking Invokana or Invokamet, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.