INVOKANA may increase your risk of lower-limb amputations.
In a recent study called the CANVAS trial, INVOKANA was studied in a group over 10,000 adults who had type 2 diabetes for an average of 13.5 years. In this study, an increased risk of amputations, mostly, but not limited to, toes and feet was observed.
During the study, a total of 187 patients out of more than 10,000 patients had a lower-limb amputation-representing an increase in the INVOKANA group over the placebo (sugar pill) group that was equal to about one more amputation for every 100 patients over the course of 3 years.
Nearly all (nine out of ten) patients taking INVOKANA who had an amputation in the study had one or more of the following conditions:
Lower-limb infection, Gangrene, Foot ulcer, Poor circulation, and/or a history of prior amputation.
This increased risk of amputation was not seen during 12 other completed INVOKANA clinical trials that included 8,000 patients with type 2 diabetes.
People with type 2 diabetes are more likely to have foot problems, including amputations. Be sure to inspect your feet every day, and seek care early if you notice any changes in your feet.
You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels usually in your leg, have damage to the nerves (neuropathy) in your leg, have had diabetic foot ulcers or sores. (source)