In addition, the European Medicines Agency (EMA) has also warned about a potentially increased risk of amputations for anyone taking SGLT2 inhibitors.
Related: Invokana Lawsuit
The two lawsuits were filed last month in New Jersey State Court – the Superior Court of New Jersey Law Division, Middlesex County. Defendants named in the suits are Johnson & Johnson, Co. and Janssen Pharmaceuticals, Inc. The plaintiffs are two men who each lost a limb which they allege was a result of their use of Invokana.
One plaintiff is an Alabama resident, Robert E. Shook. His lawsuit petition sstates that he began treatment with Invokana in January 2015. Mr. Shook lost his left foot and part of his leg below the knee on or about December 15, 2015 and January 15, 2016.
The second Invokana lawsuit was filed for Michael A. Wilkinson. The 53-year-old Iowa man alleges that after he began taking Invokana in April 2015, he suffered a below the right knee amputation on or about December 14, 2015
Both lawsuits contend Johnson & Johnson and Janssen concealed and continue to conceal their knowledge of Invokana’s unreasonably dangerous risks of lower limb amputations. The lawsuits also allege the defective nature of Invokana can cause other problems. Besides the tragic amputations suffered by Mr. Shook and Mr. Wilkinson, the suits allege people who were prescribed and took Invokana risked or suffered additional severe and permanent personal injuries, including amputations, kidney failure, diabetic ketoacidosis, stroke, and heart attack.
Invokana Approved in 2013
The U.S. FDA approved Invokana (canagliflozin) in March 2013 for the treatment of type 2 diabetes. The European Medicines Agency (“EMA”) allowed Invokana sales in the European Union in November 2013. Despite its frightening risks, Invokana has been one of Janssen and Johnson & Johnson’s top selling drugs. J&J reported worldwide Invokana sales of $1.31 billion in 2015 and $1.41 billion in 2016.
Invokana Amputation Risk Warning from Europe
On February 24, 2017, the EMA issued information “about a potential increased risk of lower limb amputation (mostly affecting the toes) in people taking the SGLT2 inhibitors canagliflozin [Invokana], dapagliflozin [Farxiga] and empagliflozin [Jardiance].” The EMA review of SGLT2 inhibitors was triggered by an increase in lower limb amputations reported for patients taking canagliflozin (Invokana) in two large clinical trials, CANVAS and CANVAS-R, even though the final results of those trials had not yet been made public. The EMA wrote: “[A]n increase in lower limb amputations has not been seen in studies with other medicines in the same class, dapagliflozin and empagliflozin. However, data available to date are limited and the risk may also apply to these other medicines.”
FDA Warning of Invokana Amputation Risk
On May 16, 2017, the FDA issued a Drug Safety Communication that confirmed an “increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR).” The Drug Safety Communication noted: “[B]ased 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.”
Clinical Trials Out Invokana
The two clinical trials the FDA relied on in requiring new Invokana label warnings were the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus).
The FDA also announced in the May 16, 2017 Drug Safety Communication that it was “requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.” The “Boxed Warning,” also known as a “Black Box Warning,” was added in the United States to the Invokana label/package insert on July 25, 2017. It states:
WARNING: LOWER LIMB AMPUTATION
See full prescribing information for complete boxed warning.
In patients with type 2 diabetes who have established cardiovascular disease (CVD) or at risk for CVD, INVOKANA has been associated with lower limb amputations, most frequently of the toe and midfoot; some also involved the leg (5.1)
Before initiating, consider factors that may increase the risk of amputation. Monitor patients receiving INVOKANA for infections or ulcers of the lower limbs, and discontinue if these occur. (5.1)
The EMA commendably notified people promptly about the potential for an increased risk of lower limb amputations with the use of any SGLT2 inhibitor before the final CANVAS and CANVAS-R study results were published. The FDA also acted swiftly in requiring a label change after the publication of the final results from the two clinical trials that “showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment.”
The FDA also noted that the risk of leg and foot amputations may be even higher for some people, “including those who have peripheral vascular disease, neuropathy (nerve damage), or diabetic foot ulcers (sores), or who have a history of prior amputation.”
Invokana / Invokamet Lawsuit
Invokana and Invokamet appear to double the risk of lower limb amputations. Anyone suffering the tragic loss of toes or a foot or limb as the result of using a dangerous drug is deserving of financial compensation, in our view. Our law firm exists to seek justice for those injured by dangerous drugs and medical devices. If you or someone you love lost a limb following use of Invokana, Invokamet or some other SGLT2 inhibitor used for type 2 diabetes, contact us for a free legal consultation in a potential lawsuit.