Parker Waichman Comments Study Reveals Invokana Tied With Two-Fold Risk Of Amputation

Research reveals Invokana (canagliflozin) doubles first-time amputation risks and increases amputation risks in patients who have undergone a prior amputation.

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Parker Waichman LLP

Jul 12, 2017, 13:51 ET

PORT WASHINGTON, N.Y., July 12, 2017 /PRNewswire/ -- Parker Waichman LLP, a national personal injury law firm dedicated to protecting the rights of victims injured by defective drugs, comments on research findings involving the Type 2 diabetes medication, Invokana (canagliflozin), which is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Canagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor being researched under the Canagliflozin Cardiovascular Assessment Study (CANVAS) and the CANVAS renal-end-points trial (CANVAS-R), according to a June 12, 2017 MedScape Medical News report. (http://www.medscape.com/viewarticle/881499)

Although the research reveals that Invokana reduces cardiovascular events by 14 percent and renal decline by 40 percent, the drug doubles risks for lower limb amputation, according to new cardiovascular-outcomes trial data, according to MedScape Medical News. The combined results from the studies were presented at the American Diabetes Association (ADA) 2017 Scientific Sessions and published in the New England Journal of Medicine.

The CANVAS data showed what was described as a significant doubling in amputation risks, specifically of the toe or metatarsal. The risk of amputation is highest in patients with a baseline history of previous amputation, peripheral vascular disease, and neuropathy. The risk had been previously identified, leading to a boxed warning from the U.S. Food and Drug Administration (FDA) for canagliflozin, as well as warnings on all SGLT2 inhibitors by the European Medicines Agency. According to MedScape Medical News, a black box or boxed warning is the FDA's most serious warning.

Cardiovascular death was not significantly reduced in CANVAS research. The so-called "CANVAS program" combined data from CANVAS and CANVAS-R and involved 10,142 patients diagnosed with Type 2 diabetes and high cardiovascular risk. In addition to a reduction of major cardiovascular adverse events (MACE) and risk of hospitalization for heart failure and renal events, amputations were found to occur in 15 more patients per 1000 over five years. It is unknown if the amputation risk is a class effect; however, in February 2017, the EMA indicated in a statement that, "… data available, to date, are limited and the risk may also apply to these other medicines."

"The firm takes Invokana amputation risks seriously and is investigating potential lawsuits on behalf of individuals injured by Invokana. As a firm that has had decades of experience successfully representing clients in defective drug lawsuits, we keep up-to-date with drug injury news," said Keith Gitman, Managing Attorney at Parker Waichman.

Filing an Invokana Amputation Injury Lawsuit

Parker Waichman has years of experience representing clients in drug injury lawsuits. If you or someone you know is interested in filing an Invokana amputation lawsuit, please contact one of our experienced drug injury lawyers today. Our firm offers free, no-obligation case evaluations. For more information, visit our Defective Drug page or call 1-800-YOURLAWYER (1-800-968-7529). (http://www.yourlawyer.com/practice-areas/defective_drugs)

SOURCE Parker Waichman LLP