FDA Says Invokana Poses Increased Risk of Leg, Foot Amputations

WASHINGTON, D.C. — Based on new data from two large clinical trials, the Food and Drug Administration has concluded that type 2 diabetes drug Invokana (canagliflozin) poses an increased risk of leg and foot amputations.

According to a May 16 alert, the FDA is requiring the drug’s manufacturers to include a Boxed Warning regarding the risk of amputation to be added to the drug’s labeling.

“Final results from two clinical trials — the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) — showed …