FDA issues safety alert for diabetes meds Invokana, Invokamet

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday issued a safety alert about the diabetes medicine canagliflozin (Invokana, Invokamet). An ongoing clinical trial has found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the drug.

 

Although the FDA has not determined whether canagliflozin increases the risk of leg and foot amputations, it is currently investigating the issue and will update the public when it has more information.

 

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.

 

The FDA recommends that healthcare professionals 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.

 

The FDA also cautions patients to not stop or change their diabetes medicines without first talking to their healthcare professional. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Patients taking canaglifozin should notify their healthcare professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.

 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program, either using the online form or by calling 1-800-332-1088 to request a reporting form.