The U.S. Food and Drug Administration (FDA) has recently issued a warning about Invokana side effects, a type-2 diabetes drugs that has purportedly increased a patient’s risk of suffering from lower limb amputations and diabetic ketoacidosis.

Invokana (canagliflozin), Invokamet, (canagliflozin metformin), and Invokamet XR (canagliflozin and metformin hydrochloride extended release), are all associated with a class of drugs known as sodium-glucose contransporter-2 (SGLT2) inhibitors.

How does Diabetes Cause Amputation?

The FDA says recent studies show a link between amputations of the body’s lower extremities, such as the foot and leg, with the class of sodium-glucose co-transporter-2 drugs. These drugs include Invokana, Invokamet, and Invokamet XR. Clinical studies have illustrated that patients who are taking these class of drugs are more likely to suffer and undergo Invokana amputation in their lower extremities.

These clinical studies compared the incidence of lower extremity amputation in patients who took SGLT-w2 inhibitors to the same incidence in patients who took a placebo.

The lower body amputation includes the body parts of the toe, foot, knee, or leg. The question of how does diabetes cause amputation is commonly known. It is known that diabetic amputations of the toe and middle of the foot can be common in patients who suffer from this condition.

A patient who suffers from a diabetic condition may lose feeling in the body’s lower extremities. With the loss of feelings and sensations, infections may occur and increase, and with the spread of an infection, amputation may be the only solution to prevent the infection from spreading to other parts of the body.

According to Dr. Joseph LeMaster in an article written for Health.com, people with a loss of sensation from diabetes can just walk over a blister in their foot as though it wasn’t there.

These blisters “can burst, become infected, and turn into what we call a foot ulcer,” he says. “That ulceration can go right down to the bone and become an avenue for infection into the whole foot. That’s what leads to amputations.”

Due to patients taking this class of drugs, however, diabetic amputations from the leg and both above and below the knee have also occurred. Even more, patients, according to the FDA, have suffered from amputations in both limbs.

The result of an increase in Invokament amputation resulted in the FDA to release the following safety announcement in May 2017. The Invokamet amputation safety announcement stated that “[b]ased on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.”

“We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk,” the announcement says.

Reports have also shown that Invokamet amputation and Invokana amputation may also be more frequent in certain patients and particularly those who have peripheral vascular disease, nerve damage, or neuropathy, diabetic foot ulcers, or a history of diabetes amputation.