FDA Investigating Increase in Leg, Foot Amputations in Patients Treated With Invokana

WASHINGTON, D.C. — The Food and Drug Administration says it is investigating interim results from an ongoing clinical trial that found an increase in leg and foot amputations in patients treated with Invokana and Invokamet (canagliflozin).

In a May 18 Drug Safety Communication, the FDA clarified that it has not determined whether canagliflozin increases the risk of leg and food amputations and is currently investigating this new safety issue, which was brought to light in the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) Clinical Trial.

“The trial’s independent data monitoring committee (IDMC) identified an increased risk of leg and foot amputations. …