Based on new data from two large clinical trials, the FDA concluded that the type 2 diabetes medicine canagliflozin (brand names Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. The FDA is requiring new warnings, including their most prominent Boxed Warning, be added to the canagliflozin drug labels to describe this risk.

Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.

Report side effects involving canagliflozin and other medicines to the FDA MedWatch program at fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at fda.gov/DrugSafetyCommunications. If you have drug questions, contact the FDA at druginfo@fda.hhs.gov.

Released 5/16/2017