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# FDA Alert on Canagliflozin Associated with Amputations
- URL: https://www.fdaweb.com/fda-alert-on-canagliflozin-associated-with-amputations/
- Published: 2016-05-18T12:00:00.000Z
- Updated: 2026-09-14T21:03:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135706

FDA has issued a drug safety [alert](http://www.fda.gov/Drugs/DrugSafety/ucm500965.htm?ref=fdaweb.com) on Janssen’s diabetes medicines containing canagliflozin (Invokana and Invokamet) after data from an ongoing clinical trial showed an increase in leg and foot amputations, mostly affecting the toes. The ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) identified amputations that occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo.

The agency says it has not determined whether canagliflozin increases the risk of leg and foot amputations, and it is currently investigating the incidents. For now, FDA says that healthcare professionals should follow the recommendations in the canagliflozin drug labels, and monitor patients for any new pain or tenderness, sores or ulcers, or infections in their legs or feet.