> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves Boxed Warning on Canagliflozin
- URL: https://www.fdaweb.com/fda-approves-boxed-warning-on-canagliflozin/
- Published: 2017-07-26T12:00:00.000Z
- Updated: 2026-09-14T22:36:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139225

FDA has approved a new Boxed Warning on canagliflozin (Janssen’s Type 2 diabetes drugs Invokana, Invokamet, and Invokamet XR) based on recent safety data ([see earlier story](https://www.fdaweb.com/fda-sees-invokana-amputation-risk/)) that indicate it causes an increased risk of leg and foot amputations. A recent [drug safety communication](https://www.fda.gov/Drugs/DrugSafety/ucm557507.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) recommends that patients taking the drug notify their healthcare professionals right away if they develop new pain or tenderness, sores or ulcers, or infections in their legs or feet. The notice also says that in the CANVAS trial, the risk of amputation was 5.9 out of every 1,000 patients treated with canagliflozin and 2.8 out of every 1,000 treated with placebo, while in the CANVAS-R study, it was 7.5 out of 1,000 treated with canagliflozin and 4.2 out of every 1,000 treated with placebo. To view the revised labeling, click [here](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/label/2017/204353s023lbl.pdf?ref=fdaweb.com).