Drug Information Update- New Drug Safety Communication on Canagliflozin

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). We have not determined whether canagliflozin increases the risk of leg and foot amputations. We are currently investigating this new safety issue and will update the public when we have more information.

Patients should not stop or change their diabetes medicines without first talking to their health care professional. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canaglifozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.

Health care professionals should follow the recommendations in the canagliflozin drug labels. Monitor patients for the signs and symptoms described above and advise patients to seek medical advice if they experience them.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

We are continuing to evaluate this safety issue and will update the public when we have more information. We urge health care professionals and patients to report side effects involving canagliflozin or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

For more information, please visit canagliflozin.