Invokana® Leg and Foot Amputations

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Invokana® Increased Risk of Leg and Foot Amputations

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The US Food and Drug Administration (FDA) has issued a new boxed warning to the label of the type-2 diabetes drugs Invokana® and Invokamet®. Diabetic foot is a common side effect in people with type-2 diabetes. Diabetes can destroy nerve endings in the feet and harden blood vessels that carry blood to the toes. Ulcers, sores, and infections can be common in the legs and feet of diabetics. If the condition becomes serious and the area does not heal, it sometimes requires amputation.

These medications are manufactured by Janssen and are also known as Canagliflozin. Two clinical trials with large sample groups have shown an increased risk of leg and foot amputations. The studies showed the risk of amputation was approximately 7 amputations per 1,000 patients on Invokana®. With the placebo, there were 3 amputations per 1,000–more than double the risk. The FDA is now requiring Janssen to include new warnings, including the most stringent Black Boxed Warning, to be added to the Invokana® label.

The FDA noted that most of the amputation reports from people taking Invokana® involve toes and the middle foot. However, the study showed that leg amputations above and below the knee did occur. Some patients taking Invokana® had multiple toes or both legs amputated, according to the study.

The Invokana® Studies

The heightened Invokana® warning from the FDA was the result of getting the final results from two trials. The two studies are known as: CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus). Both Studies showed similar increases in the incidence rate of amputations. They indicated an approximately twice the risk for both leg and foot amputations in for patients taking Invokana®/canagliflozin as compared to those patients who were randomly assigned to receive placebo.

Patients taking Invokana®/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 doctor if you have questions or concerns. Please do not stop taking your diabetes medicine without first talking to your health care professional.

Free Legal Consultation

Please call my office if you think you have a claim against the manufacturer of Invokana®. If you call my office, you will speak to me personally. I will listen, assess, and guide you through this process. The consultation is free of charge and completely confidential. You will pay nothing unless we are successful with your claim. All of our agreements are on a contingency fee basis.

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