Thousands of patients are filing Invokana lawsuits against the drug’s manufacturers, alleging they failed to warn patients of the risk of diabetes and toe amputation.

These patients say their risk of toe, foot or leg amputation was significantly increased due to alleged defects in the type-2 diabetes drug Invokana, known generically as canagliflozin.

Adverse side effects linked to Invokana have allegedly included:

• Amputation Risks
• Diabetic Ketoacidosis (DKA)
• Lactic Acidosis
• Kidney and Blood Infections
• Acute Kidney Injury Warning

Diabetes and Toe Amputation

There have been a multitude of adverse side effects linked to Invokana, according to patients. The U.S. Food and Drug Administration (FDA) continues to receive adverse event reports because of serious injuries associated with the diabetes medication.

Invokana (canagliflozin) is a medication used for type-2 diabetes. It is part of the subtype 2 sodium-glucose transport inhibitors class. The drug was FDA-approved on March 29, 2013. However, according to FDA warnings, Invokana has been associated with conditions such as diabetic ketoacidosis, high acid levels in the blood, kidney injuries, bone fractures, and more recently amputation.

According to an FDA safety announcement made in May 2017, the agency reported on the association between diabetes and toe amputation and Invokana.

“Based 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,”the agency said.

They also added that they were “requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.”

Canagliflozin is sold under the brand names Invokana, and in combination with metformin, a diabetes medication, under brand names Invokamet XR and Invokamet.

In addition to cardiovascular concerns, there has been additional research showing urinary tract infections and low blood pressure adverse side effects. In fact, a member of a prominent watchdog group, Dr. Sydney Wolfe of Public Citizen, argued that when it comes to adverse side effects and complications linked to Invokana, he stated that its risks outweigh its benefits, and that the drug should not be approved.

Other safety groups, such at the Institute for Safe Medication Practices (ISMP), said that at the time of Invokana’s approval by the FDA, that it had not been adequately tested through clinical trials. The cornerstone of any drug approved by the FDA is whether or not a drug’s benefits in fact outweigh its risks.

The FDA ordered a black box warning for Invokana in May 2017, the strongest warning the FDA may issue. It advised of the risk for toe, leg, and foot amputations. The warning was based off  two clinical trials that discovered that patients with diabetes and taking Invokana were twice as likely to suffer from an amputation than in patients with diabetes that took a placebo.