An Invokana side effects lawsuit has been filed against Janssen alleging that the type-2 diabetes medication increased diabetes toe amputation risk.

Plaintiff Douglas B. recently filed an Invokana side effects lawsuit against Janssen Pharmaceuticals, alleging that the type-2 diabetes medication can cause serious infections which can lead to diabetes toe amputation.

Douglas says he began taking Invokana in April 2017 to treat diabetes. In August 2017, Douglas had to undergo a diabetic toe amputation, according to his complaint. He argues that his amputation was a direct result of his Invokana usage.

Invokana is an SGLT2 inhibitor approved by the FDA to treat type-2 diabetes. SGLT2 inhibitors are designed to reduce glucose reabsorption in an attempt to lower blood glucose levels in diabetic patients.

Instead of being absorbed and metabolized, excess glucose is excreted through the kidneys. As a result, the body turns to fat as an alternative source of energy. When the body breaks down fats to create energy, acids called ketones are created as a byproduct.

The Invokana side effects lawsuit alleges that the mechanism of the drug exposes users to an increased risk of injuries and including ketoacidosis. Allegedly, the kidneys are unable to filter ketones out of the blood to due to strain put on them by expelling significant amounts of glucose.

“Under normal circumstances, a person relies on the emergency jettison of excess sugar and ketones to maintain blood-acid balance through frequent urination only when in dire need, but INVOKANA forces this very same emergency process on its users as its primary course of treatment daily,” the Invokana side effects lawsuit claims.

The lawsuit argues that prolonged use of Invokana and increased elimination via urination can reduce blood flow and thicken the blood plasma, causing circulation problems in the lower extremities. When a patient experiences poor circulation, they are less able to heal and fight infections which can increase the risk of ulcers.

Diabetic patients are at high risk for ulcers which can lead to dangerous infections that may spread into bones. A diabetes toe amputation is often necessary when an infected ulcer affects a diabetes patient.

In June 2017, a study showed that Invokana users were nearly twice as likely to suffer from an amputation as those who took the placebo. Due to these findings, the FDA mandated a black box warning in 2017 providing an amputation warning.

In addition to circulation and infection risks, Invokana allegedly carries a risk for ketoacidosis and kidney injuries. The FDA has allegedly received multiple reports regarding severe kidney damage in Invokana users.

Due to the volume of reports, the FDA has required a series of label changes to the drug packaging to warn consumers about the potential risk for fatal diabetic ketoacidosis and kidney failure, the lawsuit states.

“Invokana [is] more likely to cause serious injuries, including heart attack, stroke, renal failure, renal impairment, renal insufficiency, ketoacidosis and amputations, than other diabetes medications,” the Invokana side effects lawsuit states.

Douglas accuses Janssen of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, unjust enrichment, fraud, and violation of consumer protection laws.

The Invokana side effects lawsuit seeks a trial by jury, damages, court costs and attorney’s fees.

The Invokana Side Effects Lawsuit is Case No. 3:18-cv-03784-BRM-LHG in the U.S. District Court for the District of New Jersey.