A man has filed an Invokana lawsuit alleging the diabetes medication caused side effects that led to amputated toes.

Plaintiff Anthony G. said he started taking Invokana to treat diabetes in January 2016. In September 2016, he said he had the fourth and fifth toes of his right foot amputated.

Anthony alleges the amputated toes were a result of adverse side effects of taking Invokana, which is designed to control blood sugar levels in type-2 diabetics.

Invokana (canagliflozin) is made by Johnson & Johnson subsidiary, Janssen Pharmaceuticals.

FDA-approved in 2014, Invokana initiated a new class of medications known as SGLT2 inhibitors. Invokana and similar drugs eliminated excess sugar in the body by redirecting the glucose from the bloodstream to the kidneys allowing the sugar to be excreted through the urine.

Invokana allegedly places excess duress on the kidneys of diabetic patients who already are at an increased risk for kidney disease.

According to the amputated toes lawsuit, Invokana promotes the elimination of the body’s main fuel, glucose, through the urine. The body then begins to burn fat for energy. When fat is broken down as an energy source, acids called ketones enter the blood stream, prompting an excess of ketones in the blood.

The result of excess ketones in the blood is a condition known as ketoacidosis, and the body reacts by increasing the frequency of urination.

According to the amputated toes lawsuit, “One of the effects of the increased elimination via urination is volume contraction in the blood, which can reduce blood flow and thicken the blood plasma, creating circulation problems in the lower extremities.”

Normal circulation to the extremities allows the body to heal and fight off infections. Impeded circulation can lead to an increased risk of skin ulcers that can become infected all the way to the bones.

Amputated Toes Lawsuit Alleges Invokana is Dangerous

The amputated toes lawsuit alleges Johnson & Johnson knew of the increased risk of severe injury to Invokana users, but “continued to defend and aggressively promote Invokana, mislead physicians and the public, and minimize unfavorable findings.”

The Invokana warning label did not include a black box warning on the risk of amputation until July 2017. At that time, the FDA released the final results from two clinical trials.

The CANVAS (Canagliflozin Cardiovascular Assessment Study) and the CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus) indicated that leg and foot amputations occurred approximately twice as often in those patients who took Invokana compared with those treated with an inactive placebo.

The studies allegedly showed that amputated toes and amputations of the middle of the foot were most likely, but some patients needed amputations that involved the leg, either below or above the knee. Some patients underwent more than one amputation that involved more than one limb.

The Amputated Toes Lawsuit is Case No. 3:18-cv-03931-BRM-LHG in the U.S. District Court for the District of New Jersey.