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TAKEN FROM THE REVISED LABEL AS REQUIRED BY THE FDA:
"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. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk." 5-16-2017 FDA Safety Announcement - Invokana
"WARNING: LOWER LIMB AMPUTATION • An approximately 2-fold increased risk of lower limb amputations associated with INVOKANA use was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD. • Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs. • Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. • Monitor patients receiving INVOKANA for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur [see Warnings and Precautions (5.1)].
WARNINGS AND PRECAUTIONS
5.1 Lower Limb Amputation An approximately 2-fold increased risk of lower limb amputations associated with INVOKANA use was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials evaluating patients with type 2 diabetes who had either established cardiovascular disease or were at risk for cardiovascular disease. In CANVAS, INVOKANA-treated patients and placebo-treated patients had 5.9 and 2.8 amputations per 1000 patients per year, respectively. In CANVAS-R, INVOKANA-treated patients and placebo-treated patients had 7.5 and 4.2 amputations per 1000 patients per year, respectively. The risk of lower limb amputations was observed at both the 100 mg and 300 mg once daily dosage regimens. The amputation data for CANVAS and CANVAS-R are shown in Tables 2 and 3, respectively [see Adverse Reactions (6.1)].
Amputations of the toe and midfoot (99 out of 140 patients with amputations receiving INVOKANA in the two trials) were the most frequent; however, amputations involving the leg, below and above the knee, were also observed (41 out of 140 patients with amputations receiving INVOKANA in the two trials). Some patients had multiple amputations, some involving both lower limbs.
Lower limb infections, gangrene, and diabetic foot ulcers were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy.
Before initiating INVOKANA, consider factors in the patient history that may predispose to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy and diabetic foot ulcers. Counsel patients about the importance of routine preventative foot care. Monitor patients receiving INVOKANA for signs and symptoms of infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue INVOKANA if these complications occur.Type your paragraph here.
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Invokana use has been linked to a doubling of the risk of amputation of the legs and feet. In May of 2017, the FDA required a Black Box Warning on Invokana labeling informing patients of this increased risk. If you or a loved one took Invokana and had a leg, foot or toe amputated, contact us immediately to discuss your legal rights to receive compensation for this injury with an Invokana Amputation Settlement Lawyer.
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In March of 2013, Invokana was approved by the FDA to treat type 2 diabetes. It is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
On December 4, 2015 the FDA issued a Safety Announcement that Invokana and similar medications increased the risk of ketoacidosis.
On May 18, 2016, the FDA warned that preliminary results from ongoing clinical trials were showing a doubling of the risk of amputations of the leg and foot in patients using Invokana.
On May 16, 2017 the FDA announced they had concluded there was indeed an increased risk of amputations in patients using Invokana.
On June 14, 2016 the FDA issued a Safety Announcement announcing "The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk."
On July 25, 2017, the FDA required the manufacturer to warn patients of the 2-fold increased risk of amputations of the leg, foot and toes on it's Invokana, Invokamet and Invokamet XR drug labels.
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2018 Copyright: Cynthia K. Garrett, Attorney at Law. All rights reserved.