danielle ward mason Invokana clinical trial shows drug doubles risk of amputationJohnson & Johnson’s Jansen Pharmaceuticals just wrapped up a seven-year clinical trial for Invokana, which helps patients with type 2 diabetes lower their blood sugar. As previously reported by Beasley Allen, the clinical trial called Canagliflozin Cardiovascular Assessment Study (CANVAS/CANVAS-R) was conducted to monitor the drug’s cardiovascular risks.

According to Bloomberg, Jansen reported Invokana reduced the risk of cardiovascular complications in diabetic patients, but it also doubled the number of amputations for patients taking Invokana compared to the placebo.

The latest findings prompted the Food and Drug Administration (FDA) to require a new black box warning for Invokana explaining that the drug increases a patient’s risk of leg and foot amputations, Forbes reports. Righting Injustice confirms that some patients have endured multiple amputations, with amputations of toes and the middle part of the foot the most commonly reported.

Jansen’s conclusion that Invokana reduced the risk of cardiovascular complications was surprising, since such complications were a cause for concern for the FDA Advisory committee earlier in the approval process. During the first month of Invokana’s initial tests, 13 participants receiving the drug had a heart attack or stroke, compared to only one in the placebo group.

The drug was FDA approved in 2013 as the first in a new class of type 2 diabetes drugs called SGLT2 inhibitors. The following year the agency approved Invokamet, a combination of Invokana and metformin.

By 2015, more than 100 reports of acute kidney injury in patients taking the drug led the FDA to order a stronger kidney warning accompany several SGLT2 inhibitors, including Invokana and Invokamet. Current warnings reflect the drugs increase the risk of diabetic ketoacidosis (DKA) or severe kidney damage, caused when too much acid builds up in the blood.

Invokana has come under fire recently because of its adverse side effects, especially for DKA. The drug is at the center of nearly 300 lawsuits, which are a part of a multidistrict litigation (MDL) in the U.S. District Court for New Jersey with Judge Brian R. Martinotti presiding. The MDL’s first bellwether trial is expected to begin in September 2018.

Lawyers in Beasley Allen’s Mass Torts Section are investigating claims on behalf of individuals and families who allege they were injured by Invokana and Invokamet, specifically cases involving DKA, acute kidney injury, heart attack and stroke. If you would like more information, contact Danielle Ward Mason, a lawyer in our Mass Torts Section. She can be reached at 800-898-2034 or by email at Danielle.Mason@beasleyallen.com.

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