Invokana, Invokamet, and Invokamet XR have been linked to an increased risk of amputation.
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.
READ MORE: FDA Notice
Invokana, a diabetes drug made by Johnson & Johnson, decreases the risk of heart attacks and strokes, but also increases the risk of amputation, particularly of toes.
READ MORE: Forbes
Johnson & Johnson (JNJ.N) is required to add new warnings to its diabetes drug, Invokana, about the risk of foot and leg amputations, the U.S. Food and Drug Administration said on Tuesday.
Final results from two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana, known also as canagliflozin, as those given a placebo, the FDA said in an announcement posted on its website.
READ MORE: Reuters
• Heart attack, stroke, death 14 percent lower with Invokana
• Higher rate of amputations and fractures could limit use
Johnson & Johnson’s pill Invokana reduced the risk of cardiovascular complications in diabetic patients, making it the second medication of its kind to help the heart, but the benefit came with an increased risk of amputations and perhaps broken bones, researchers said.
READ MORE: Bloomberg