The FDA is investigating a clinical trial linking Invokamet to a doubled risk of leg, foot, and toe amputations. The problem is that Invokamet often causes dehydration, which exacerbates circulation problems in the lower legs.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Invokamet induced injury cases in all 50 states. If you or somebody you know needed an amputation, 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 Amputation Risk
In May 2017, the FDA ordered drug-makers to add a “Black Box” label to warn patients that Invokamet doubles their risk of needing a toe, foot, or leg amputation. 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 legs.
What is the problem?
Foot disease is the #1 reason why diabetic patients are hospitalized. Any medications that further increase this risk may not be beneficial in the long run. About 15% of all diabetics develop foot ulcers, and approximately 25% of these patients must undergo a toe amputation.
Invokamet May Double Risk of Amputations
The CANVAS clinical trial began in 2009 and enrolled 4,330 patients to receive canagliflozin (100-mg or 300-mg per day) or a placebo. Unfortunately, preliminary data suggests that Invokamet could double the risk of amputations — especially toe amputations.
The study found that after one year, the following number of patients needed amputations:
- 7 out of 1,000 patients on 100-mg canagliflozin
- 5 out of 1,000 patients on 300-mg canagliflozin
- 3 out of 1,000 patients on a placebo
FDA Investigates Amputations from Invokamet
In May 2016, the FDA issued a preliminary Safety Communication to announce they were investigating data from the CANVAS study linking Invokamet and amputations. 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.
Invokamet and Amputations
Invokamet contains canagliflozin, a new type of diabetes drug that works by forcing the body to remove more sugar in urine. Excessive urination causes dehydration (loss of water and salt), which decreases the amount of blood in the body and causes poor circulation in the legs. It starves the toes of blood, oxygen, and nutrients, causing the tissue to die.
Dehydration May Play a Role in Foot Disease
In April 2016, Janssen Pharmaceuticals warned doctors in Europe that “dehydration and volume depletion might play a role in the development” of lower-limb amputations from Invokamet.
Nerve Damage
These problems are often exacerbated by neuropathy (nerve damage), which makes it hard to sense when the feet are injured. Even minor cuts can rapidly become infected because they heal very slowly.
Toe Amputations
Amputation — surgery to remove diseased tissue — can save your life. It can also stop chronic pain from unhealed ulcers or prevent a life-threatening infection from spreading to the rest of the body. Toes can usually be amputated in less than an hour and most patients go home the same day.
Symptoms of Diabetic Foot
Patients may experience symptoms of foot disease, such as:
- Cold skin
- Chronic pain
- Nerve damage
- Ulcers (sores that do not heal for months)
- Poor healing
- Infections that spread rapidly
Do I have an Invokamet Lawsuit?
The Schmidt Firm, PLLC is currently accepting Invokamet induced injury cases in all 50 states. If you or somebody you know needed an amputation, 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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