Increased Risk of Leg and Foot Amputations Prompts FDA Boxed Warning for Canagliflozin

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Santa Clara,CA: The US Food and Drug Administration (FDA) has announced that it now requires new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin (Invokana, Invokamet, Invokamet XR) drug labels. The agency took the decision based on new data from two large clinical trials that show a higher risk for leg and foot amputations associated with canagliflozin use.

Final results from two clinical trials, the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus), show that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment.

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, the FDA said in a statement. Further, some patients had to have more than one amputation, some involving both limbs. See the FDA Drug Safety Communication for additional information, including a data summary.

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.

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