Janssen Pharmaceutical, Inc. is likely to see an influx of new lawsuits as the U.S. Food and Drug Administration (FDA) decides to require a Black Box warning addressing an increased risk of foot and leg amputations associated with the Type 2 diabetes drug Invokana.
The FDA’s decision follows findings by two clinical studies that determined patients taking canagliflozin, marketed as Invokana and Invokamet, were about twice as likely to require leg and foot amputation compared to patients taking a placebo.
An FDA safety communication released last month reveled that amputations of the toe and middle of the foot were most common; however, the release also cited instances of amputation involving the leg, below and above the knee, and instances of patients requiring multiple amputations, sometimes involving both legs.
In one of the studies, Canagliflozin Cardiovascular Assessment Study (CANVAS), researchers noted that rates of amputation were as high as 7 out of every 1,000 patients treated with canagliflozin – more than double the 3 out of every 1,000 rate recorded among patient receiving a placebo.
This is the latest post-market warning to be added to Invokana by the FDA, with a kidney damage warning being added in June of 2016 and a diabetic ketoacidosis being added in 2015
Other adverse events reported by patients taking Invokana include: