A woman has filed a lawsuit in New Jersey federal court within the larger multidistrict litigation taking place against the manufacturers of Invokana, a medication prescribed to treat patients with type-2 diabetes.

She claims that side effects of Invokana led to her diabetes leg amputation in 2016.

Plaintiff Cheryl R., says that she began taking Invokana in January 2015 through August 2017. Due to taking Invokana, however, she was forced to undergo the amputation of her right leg.

The diabetes leg amputation procedure was conducted at TriStar Summit Medical Center in Tennessee in November 2016, according to the side effects of Invokana lawsuit.

The companies currently facing the multidistrict litigation are Johnson & Johnson and Janssen Pharmaceuticals, Inc.

What is Invokana and What Are its Side Effects?

Invokana (canagliflozin) was approved by the U.S. Food and Drug Administration in March 2013 to treat low blood glucose in adults with type-2 diabetes. Invokana is part of a group of drugs known as sodium-glucose contransporter-2 (SGLT-2) inhibitors. There are several other medications that are a part of this class.

During the process in which blood is filtered through the kidneys, Invokana works by inhibiting sodium glucose cotransporter-2, a protein in the body. This protein aids in the reabsorption of glucose into the bloodstream through the kidneys. Although this is helpful in lowering blood sugar levels in patients, side effects of Invokana tend to result as the medication puts a great deal of stress on a patient’s kidneys.

Patients who are taking diabetes medications are already at a risk for kidney disease because of their condition.

There are some serious side effects of Invokana, and according to the FDA, a safety announcement was released in May 2017 warning about the risks of taking the medication.

The federal agency stated that based on new data released from two large clinical trials “the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.”

The federal agency asserted that they were also going to require new warning labels as well as a Boxed Warning to be added to Invokana labels warning describing this risk.

Clinical Trials Report on Side Effects of Invokana

According to the FDA, two trials were conducted regarding the risk Invokana has in causing diabetes leg amputation. One clinical trial described by the FDA is CANVAS (Canagliflozin Cardiovascular Assessment Study), while the second clinical trial is CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus).

According to the FDA, final results from the two clinical trials showed that in comparison to patients who were treated with a placebo, patients treated with Invokana were twice as likely to suffer from diabetes leg amputation.

Over a year’s time, according to final results from the CANVAS study, out of 1,000 patients, 5.9 patients treated with Invokana were at risk for diabetes leg amputation. Out of 1,000 patients, 2.8 were at risk for amputation for those who were given a placebo.

According to final results from the CANVAS-R trial, over a year’s time out of 1,000 patients, 7.5 were at risk for amputation, in comparison to 4.2 out of 1,000 patients who were given a placebo.

This Side Effects of Invokana Lawsuit is Case No. 3:17-cv-11217-FLW-LHG in the U.S. District Court for the District of New Jersey. The Invokana MDL is In re: Invokana (Canagliflozin) Products Liability Litigation, MDL No. 2750, in the U.S. District Court for the District of New Jersey.