- Last Updated: April 23rd, 2025
Invokana Lawsuits
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.
About the Author: Frank Piscitelli
As a first-generation Italian in the United States, Frank is no stranger to tough times.
His father’s family moved to Cleveland from Italy on May 22, 1958, with a few articles of clothing, some personal items and very little money.
His family shared a home with three other related families but happily worked long hours doing jobs that involved physical labor, just to put food on the table.
There was the promise of hope and opportunity, which was missing before his family moved here.
Member of the Ohio State Bar Association since 1993. With 30+ years of legal experience, Attorney Frank Piscitelli has secured over $55 million in compensation for Ohio injury victims, car accident victims, and surviving family members of Ohio wrongful death victims.
Legally Reviewed
This article has been written and reviewed for legal accuracy and clarity by the team of writers and attorneys at Piscitelli Law Firm and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced Ohio personal injury lawyer, Frank Piscitelli, you can do so here.
Fact-Checked
Piscitelli Law Firm does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us. This article should not be taken as advice from an attorney.
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