Pharmaceutical Litigation Attorney’s | Information on the side effects of Invokana
On August 17, 2017 the New England Journal of Medicine published the results of a study that involved 10,142 participants with type 2 diabetes, high cardiovascular risk, and a poor history of managing their diabetes. Over the course of several years a portion of these patients, 4,330 to be exact, would be randomly assigned to treatment with 1 or 2 doses of Canagliflozin, also know by its brand name Invokana. The other participants would be given a placebo, in this case another commonly used diabetes drug, in order to draw a comparison on Canagliflozins effectiveness.
The goal of the study know as the, Canagliflozin Cardiovascular Assessment Study, or CANVA, was to determine the risk of cardiovascular events, like heart attack and stroke, in those taking Canagliflozin (Invokana).
Although the study did go on to prove that Canagliflozin (Invokana) reduced risk of cardiovascular events within the group studied, it also determined that patients treated with Invokana had a “greater risk of amputation, primarily at the level of the toe or metatarsal.”
Greg Jones Law is currently taking cases against the makers of unsafe diabetes drugs. If you or a loved one has experienced a life changing side effect like Ketoacidosis or amputation, Contact us today for a free case evaluation on your Invokana lawsuit.
Invokana & Invokamet are from a class of diabetes drugs known as SGLT2 inhibitors. The FDA has exposed the dangers of this class of drugs and the increased risk of developing an illness called ketoacidosis in recent publications.
The patients who were picked to participate in the CANVA study fit a very strict list of requirements. Although many of these requirements seem befitting for a study of this nature, some may shed extra insight into the potential risks of associated with taking Invokana.
The CANVA conductors asked that the patients be restricted to type 2 diabetics older than 30 with a history of a cardiovascular event or older than 50 with a high risk of cardiovascular event. The patients also needed to have a higher than average level of glucose bound hemoglobin.
Users who fit within the requirements but had a history of diabetic Ketoacidosis were not allowed to participate in the study. The CANVA study was sponsored by Janssen Research and Development, LLC in conjunction with The George Institute for Global Health. Janssen Pharmaceuticals, the makers of Invokana, may be aware of the link Invokana has with diabetic Ketoacidosis. Currently they are involved in a
multi-district litigation centralized in the New Jersey State Courts involving 79 claims made against Invokana; including a claim made by a woman who was diagnosed with diabetic Ketoacidosis after taking Invokana for a few years.
Since the publishing of the CANVA study, the U.S. Food and Drug Administration (FDA) has required Invokana to carry additional labeling regarding the risk for amputation. However, previous to the conclusion of CANVA study the FDA had already released several safety warnings regarding the additional side effects of Invokana.
On June 14, 2016, the FDA strengthened the warnings labels on Invokana and Invokamet to require information about the development of a cute kidney injuries. The same safety communication also notes that the FDA had received reports of 101 cases of active kidney injury, with some involving hospitalization, after use of the Invokana and Invokamet. Many of those claims occurred after the patients were using their diabetes drug for just 1 month and stopping the dosage seemed to improve the kidney issues they were experiencing.
The reported side effects in Invokana lawsuits are amputations, Ketoacidosis, kidney injuries, acute pancreatitis, and bone fractures.
If you or anyone that you know has experienced these life altering side effects after prolonged use of Invokana, contact our firm online or call as at 855-566-3752 to speak with an experienced lawyer about an Invokana lawsuit.
Greg Jones Law has an extensive history in pharmaceutical litigation. We have helped clients in their cases against pharmaceutical companies who failed to warn of the dangers of their products nationwide. If the side effects of Invokana have disrupted your life then, contact us today.
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