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What you need to know!
If you, or someone you know, has taken the once-daily Type-2 diabetes drug Invokana and had an amputation, Please contact our Invokana attorneys at 1 (800) 515-1496 for a free case evaluation.
On May 16, 2017, the FDA concluded that Invokana causes an increased risk of leg and foot amputations. If you took Invokana and had an amputation, you could be eligible for compensation. Please contact our Invokana attorneys at 1 (800) 515-1496 for a free case evaluation.
What Is Invokana?
Invokana (canagliflozin) was the first in a new class of diabetes drugs, which work by altering normal kidney functions so that sugar is excreted through the urine. It was approved in March 2013 by the FDA, and has rapidly grown to become a blockbuster medication, generating an estimated $1 billion in annual sales.
New Study Shows Amputations
Final results from two clinical trials showed toe, leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana (Invokana, Invokamet and Invokamet XR), known also as canagliflozin, as those given a placebo, the FDA said in an announcement posted on its website.
FDA Invokana Website
The warnings include a boxed warning, reserved for the most serious possible adverse events, the FDA said. Invokana is already the subject of litigation that alleges it causes severe kidney damage including diabetic ketoacidosis.
The FDA & Invokana - Invokana Linked to Amputations of the Toe, Foot, Leg
May 16, 2017 – The U.S. Food & Drug Administration (FDA) has issued an update citing clinical trials that found an increased risk of amputation in diabetes type two patients taking canagliflozin (Invokana, Invokamet), most involving the legs and feet.
The safety announcement states:
Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.
Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur.
They advise that anyone taking the medication consult with their doctor immediately should they experience any pain or tenderness, sores, ulcers or infections in the lower limbs. They do not recommend stopping the medication without first consulting with a physician or other healthcare provider.
The most common amputations were of toe or middle foot but also included the leg and knee areas. Some patients required amputations involving more than one area, or more than one surgery.
Invokana’s manufacturer failed to warn doctors and patients of the risks of taking the Type-2 diabetes drug. If patients would have known of the increased risk for amputations, patients may have chosen a different drug to help treat their diabetes. In addition, patients could have been monitored closely for potential signs of problems.
Invokana Side Effects
Since Invokana was released to treat Type-2 diabetes, of patients have reported serious medical problems of Amputations of the Toe, Foot, Leg.
Our Invokana Lawyers Can Help
If you or a loved one has taken Invokana and had an amputation, please contact our office at 1 (800) 515-1496, or fill out the case form on this page, for a free Invokana case evaluation. You could be eligible for compensation from the drug manufacturer.