Invokana Amputation Lawsuit

The FDA is investigating a study linking Invokana with a doubled risk of amputations in the legs and feet. Toe amputations are very common in people with diabetes and cause permanent disability, but they are usually necessary to prevent deadly infections.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or somebody you know had an amputation after taking Invokana, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

FDA Adds “Black Box” Warning for Invokana Amputations

In May 2017, the FDA required a “Black Box” label to warn that patients on Invokana are twice as likely to develop diabetic foot disease complications that require an amputation. According to the Safety Announcement:

“Amputations to the toe and middle of the foot were the most common, however, amputations involving the leg, below and above the knee also occurred. Some patients had more than one amputation, some involving both limbs.”

What is the problem?

Invokana treats diabetes by increasing the amount of sugar removed from the body in urine. This can dehydrate some patients, decrease blood-volume, and cause poor circulation.

FDA Investigates Invokana Toe Amputation Risk

In May 2016, the FDA warned about preliminary data from an ongoing clinical trial that found a doubled increased risk of amputations in patients on Invokana compared to a placebo. According to the FDA, patients taking canaglifozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.

What Causes Diabetic Foot?

• Poor circulation: High blood-sugar causes blood vessels to narrow and harden, which decreases the amount of blood, oxygen, and nutrients that reach the toes. Over time, tissues begin to die (called “necrosis”).
• Nerve damage: Diabetes also causes nerve damage in the feet (called “peripheral neuropathy”), which decreases sensation. Accidental injuries may go unnoticed, which increases the risk of infection. Minor cuts can rapidly develop infections that spread.

What is the problem?

The problem is that foot complications are extremely common in people with diabetes — about 15% will develop sores that do not heal called ulcers, and 25% of people with ulcers need an amputation. Any medications that further increase these risks must be carefully considered.

Study Links Invokana and Doubled Risk of Amputations

The CANVAS clinical trial enrolled 4,330 patients and randomly assigned them to take Invokana (100-mg or 300-mg a day) or a placebo. The study began in 2009 and patients have been tracked for an average of 4.5 years.

Preliminary data shows that Invokana doubles the risk of toe amputations. The researchers found that after taking Invokana or a placebo for one year, amputations occurred in:

• 7 out of 1,000 patients on the 100-mg dose
• 5 out of 1,000 patients on the 300-mg dose
• 3 out of 1,000 patients on a placebo

EMA Investigates Invokana Amputation Risk

Medscape reports that safety regulators with the European Medicines Agency (EMA) have asked Janssen Pharmaceuticals for more data. They are also asking whether label changes are necessary. Click here to read more.

Symptoms of Foot Problems

Toes help you balance and move around. When they do not get enough blood, symptoms may include:

• Cold skin
• Chronic pain
• Skin becomes darker or black
• Ulcers
• Injuries do not heal
• Infections spread rapidly

Toe Amputations

Surgery to remove the toes is called an amputation — and it can save your life. The surgery usually takes less than an hour and most patients go home the same day. In some cases, only part of the toe is removed. In others, multiple toes or the entire leg is removed to remove dead tissue and prevent infections from spreading.

How to Prevent Foot Problems

Recommendation for Diabetes Patients

• Check your feet every day
• Wash your feet every day
• Keep the skin soft and smooth
• Smooth corns and calluses gently
• If you can see, reach, and feel your feet, trim your toenails regularly. If you cannot, ask a foot doctor (podiatrist) to trim them for you.
• Wear shoes and socks at all times
• Protect your feet from hot and cold
• Keep the blood flowing to your feet

Do I have an Invokana Lawsuit?

The Schmidt Firm, PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or somebody you know had an amputation after taking Invokana, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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