Final results from two independent clinical trials indicate the amputation risk for users of the Type 2 Diabetes drug Canagliflozin, marketed as Invokana, Invokamet, Invokamet XR, are much greater than previously understood.

The FDA was so concerned about the information the studies provided that it moved immediately to ensure consumers are warned about the increased risk of leg and foot amputations through a Boxed Warning label on all Invokana prescriptions.

According to the FDA safety communication on May 15, 2017, “Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.”

“Our firm is investigating both Ketoacidosis cases and we are also investigating amputation cases,” says Frank Piscitelli. “We have a number of clients we are working with and I think at the end of the day what this new information shows, and will show in court, is that Johnson & Johnson did know that this risk existed and chose not to do anything about it.”

Canagliflozin is licensed for sale in North America by Johnson & Johnson subsidiary Janssen Pharmaceuticals. The drug is designed to be used in combination with diet and exercise to lower blood sugar levels in Type 2 diabetes patients. The drug is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that causes sugar to be eliminated through the urine.

Invokana was first approved for sale by the FDA in March 2015. Within three months the FDA had 100 reports of Ketoacidosis and kidney damage in Invokana users. In May 2015, the FDA ordered the label contain a Ketoacidosis warning. By 2016, the FDA had added possible kidney damage to the Invokana warnings. In May 2017, it added increased risk of amputation.