According to the American Journal of Managed Care, amputation in diabetics is a serious risk. Indeed, following years of decline, “the rate of amputations increased by 50 percent between 2009 and 2015to 4.6 for every 1000 adults,” according to the journal.

Amputation risk may be increased by a few major factors.

What are Risk Factors for Diabetic Amputation?

Foot ulcers are the most common sign that an amputation may be necessary, as more than 80 percent of amputations begin with foot ulcers. According to the Mayo Clinic, other factors that can contribute to a higher risk of amputation include:

• High blood sugar levels
• Smoking
• Nerve damage in the feet
• Calluses or corns
• Foot deformities
• Poor blood circulation to the extremities
• A history of foot ulcers
• A past amputation
• Vision impairment
• Kidney disease
• High blood pressure

On top of these risk factors, the class of diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors has been associated with an increased risk in lower-limb amputations.

SGLT2 Inhibitors & Increased Amputation Risk

SGLT2 inhibitors are a class of drugs used to lower blood sugar levels in patients with type 2 diabetes. Major SGLT2 inhibitors include Farxiga (dapagliflozin) and Jardiance (empagliflozin).

In 2017, the U.S. Food and Drug Administration (FDA) released a safety warning over the risk of amputation linked with SGLT2 use. According to the warning, two major clinical trials have each linked the use of canagliflozin drugs with a heightened risk of lower limb amputation. Lower limb amputation includes amputations of the toe, foot, knee, and leg.

According to recent research, SGLT2 inhibitors have been linked with a substantially higher risk of amputation than other options. The CANVAS and CANVAS-R studies found that the use of certain SGLT2 inhibitors about doubles a patient’s risk of lower limb amputation.

Previous clinical trials have connected canagliflozin drugs specifically with this risk, leading to the FDA’s warning.

Why Are SGLT2 Inhibitors Prescribed?

Also known as “gliflozin” drugs, SGLT2 inhibitors are normally prescribed as a second, or even third-line treatment for patients with type-2 diabetes. This means they are used after the patient fails to respond to first-line treatments, i.e., metformin – and particularly if obesity and/or hypertension are part of the equation. Often, drugs such as Invokana, Jardiance or Farxiga are used in combination with metformin and/or sulfonylurea drugs such as DiaBeta, Glucotrol or Amaryl, according to the BMJ.

How Do SGLT2 Inhibitors Work?

Drugs of the gliflozin class operate by preventing the action of Sodium Glucose Transport protein 2, which normally enables the kidneys to reabsorb blood sugar and release it back into the bloodstream. As a result, excess glucose is passed out of the body through urination.

Why Do SGLT2 Inhibitors Increase the Amputation Risk?

Studies so far have failed to pinpoint how gliflozin drugs raise lower limb amputation risk. However, Forbes reports that some medical experts believe that one of the effects of these drugs, which is to lower blood pressure, results in a rise in blood viscosity, causing blood to pool in the feet and lower legs.

How Serious is the Risk?

In May 2019, the U.S. Food and Drug Administration (FDA) issued a black box warning for Invokana after determining that 7 out of 1,000 patients, or .007 percent, who take the medication for a one-year period will lose a toe, foot or lower leg to amputation. However, after five years, that figure rises to approximately 1.5 percent.

Should I File a Diabetes Drug Amputation Lawsuit?

A growing number of patients are coming forward with reports of amputations and other major side effects after treatment with SGT2 inhibitors like Farxiga and Jardiance. Lawsuits allege that drug manufacturers either knew or should have known about the severe complications associated with their SGLT2 inhibitor medications, including lower limb amputation, but failed to adequately warn patients and the medical community about this risk.

If you or a loved one have suffered from lower limb amputation after taking an SGLT2 inhibitor like Farxiga or Jardiance, you may be able to work with an attorney to file a lawsuit and pursue compensation. While filing a lawsuit cannot take away the pain and suffering caused by major complications like amputation, it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.