Last week, it emerged Johnson & Johnson’s Janssen unit has asked the FDA to approve expanded uses of its diabetes drug Invokana (canagliflozin), to include reducing the risk of major cardiovascular injuries and death in those with diabetes.
The move would no doubt add millions of new customers each year. Ironically though, it comes just after the FDA added yet another safety warning for Invokana – this time for a risk of lower leg amputations.
And the study Janssen touted for the drug’s cardiovascular benefits is the same that uncovered those amputation risks.
CANVAS Study Shows Both Benefits & Risks
In June, Janssen unveiled the results of two Canagliflozin Cardiovascular Assessment (CANVAS) studies at the annual American Diabetes Association Scientific Session.
The studies, which followed more than 10,000 people in Australian for up to 8 years, found that Invokana cut the risk of major cardiovascular injuries like heart attack, stroke and death in those with type II diabetes by as much as 14%.
However, the drug also doubles patients’ chances of suffering amputation of a lower limb below the knee. In fact, many patients over 65 years old were at a high risk of gangrene, bone fracture, infections, ischemia and foot ulcers while taking Invokana.
In May, the FDA deemed the risk great enough to add a new warning to Invokana’s packaging label.
Prior FDA Warnings for Ketoacidosis and Kidney Disease
The May FDA Invokana amputation risk warning is only the latest in recent years for a drug just approved for sale in 2013.
In 2015, the agency advised that those taking Invokana may have a higher chance of developing a severe blood condition known as diabetic ketoacidosis that can cause hospitalization or even death.
In 2016, the FDA added another warning for Invokana after numerous Adverse Event Reports (AERS) showed it can increase the risks for kidney disease or failure.
Federal Panel Consolidates Invokana Lawsuits to Special Court
Despite the well-documented risks, Janssen is forging ahead with a supplemental New Drug Application (sNDA) that could bring Invokana to millions of new patients if approved.
Amid these efforts, the company faces a rising tide of Invokana lawsuits for diabetic ketoacidosis, kidney disease or failure, and now lower leg amputation.
Due to the pace at which patients have filed claims, the Judicial Panel on Multidistrict Litigation on December 7, 2016 moved all federal cases for Invokana injuries to MDL 2750, a special court in New Jersey that can handle a high volume of trials or settlements.
As of September 15th, around 770 cases had been filed and the number continues to grow.
If you or a loved one have experienced a ketoacidosis, kidney or amputation injury after using Invokana, it is important to speak with a lawyer about your options. DrugNews works exclusively with lawyers that have handled thousands of Invokana and similar drug injury cases.
For more information, or to speak directly with a lawyer at no cost, contact DrugNews today.
Janssen seeks US FDA new indication approval for Invokana to reduce risk of MACE. PharmaBiz.com. (October 4, 2017). Retrieved from www.pharmabiz.com
Tucker, M. CANVAS: Canagliflozin Reduces CV Events, but at Cost of Amputations. MedScape. June 12, 2017). Retrieved from www.medscape.com
Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.
The FDA enacted tough new regulations this week aimed at making sure all women who are considering implantation of the Essure birth control device fully understand all the risks and benefits before moving forward.