Diabetes Drug Invokana Linked to Heightened Risk of Amputation. The diabetes drug canagliflozin, which is sold under several brand names, including Invokana, Invokamet, and Invokamet XR is now sold with the FDA’s most serious form of warning label, the Black Box Warning. The decision to require the drug’s manufacturers, such as Johnson & Johnson, to include this warning in the drug’s packaging follows several studies that link canagliflozin to an increased risk of amputation, mainly of the toes, feet and lower legs.

What is Invokana or canagliflozin used for?

Invokana is used to treat individuals diagnosed with type 2 diabetes. Invokana and other brands of canagliflozin are used to control a patient’s high blood sugar. Invokana serves to increase the amount of sugar a patient’s kidneys remove from their blood. Medications that control high blood sugar can help patients to avoid blindness, problems with nerves, the loss of limbs, sexual function problems, and damage to the kidneys.

Studies show risks of amputation

Two large clinical tests of Invokana were conducted, and both yielded results that indicated that patients using this drug suffered twice as many amputations as those patients who were given a placebo. Some patients required more than one amputation. The FDA reported that the vast majority of amputations involved the removal of a patient’s toes, middle of the foot, or the lower leg.  In one study, titled Canagliflozin Cardiovascular Assessment Study, or “CANVAS,” 5.9 patients out of every 1000 patients taking canagliflozin required amputations, while only 2.8 patients out of every 1000who were taking a placebounderwent surgery for an amputation. Another study, titled A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus, or “CANVAS-R,” indicated that out of every 1000 patients taking canagliflozin, an average of 7.5 individuals required amputations compared with 4.2 out of every 1000 patients who were administered the placebo.

Why does Invokana lead to amputations?

It is possible that the heightened risk of amputation stems from the fact that Invokana works through a patient’s kidneys, which can lead to the possibility of a patient becoming dehydrated. The dehydration can lead to the blood vessels becoming constricted in the patient’s limbs, and reducing the flow of blood. As a result of decreased blood movement to extremities, foot ulcers and infections can occur, resulting in a necessary amputation.

Are there other risks to Invokana?

In addition to the risk of amputation, there are indications that Invokana can cause ketoacidosis, which is a condition marked by the buildup of acid in a person’s blood. Symptoms of ketoacidosis include vomiting that lasts more than two hours, queasiness, stomach ache, fruity smelling breath, feeling tired or confused, and difficulty breathing.

Warnings for individuals on Invokana

If a patient is taking Invokana or another form of canagliflozin, then he or she should familiarize themselves with the risks involved in taking these medications. Additionally, if new pain or tenderness, ulcers, sores, or infections in the legs or feet are experienced, it is important to contact a medical care provider immediately.

Is Invokana still prescribed?

Yes, Invokana is still prescribed to patients. The warnings issued mean that patients should be made aware of the risks involved in taking the drug, that doctors consider any already existing risks a patient might have for amputation and indicate the patient should understand what to look for as warning signs that the drug could be negatively impacting them. It is imperativethat you review your medications with your doctor and to consult your physician before you stop taking any prescriptions.

Call Us for Your Invokana Injury Case Review

If you have suffered an injury or reaction from using Invokana or any form of canagliflozin, contact an attorney to discuss your possible legal remedies. Call Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) for a free consultation with one of our experienced personal injury attorneys.

 

 

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