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# FDA Nixes Amputation Boxed Warning on Canagliflozin
- URL: https://www.fdaweb.com/fda-nixes-amputation-boxed-warning-on-canagliflozin/
- Published: 2020-08-26T12:00:00.000Z
- Updated: 2026-09-14T16:26:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147515

FDA says it is removing a Boxed Warning about amputation risk on Janssen’s diabetes drug canagliflozin’s (Invokana, Invokamet, Invokamet XR) [prescribing information](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/label/2020/204042s034lbl.pdf?ref=fdaweb.com). The agency required the warning in 2017 based on its assessment that the risk of amputations was very serious when considering canagliflozin’s benefit.

“Subsequent FDA reviews of new clinical trial data demonstrated additional heart- and kidney-related benefits, which led to additional approved uses,” a drug [update notice](https://www.fda.gov/drugs/drug-safety-and-availability/fda-removes-boxed-warning-about-risk-leg-and-foot-amputations-diabetes-medicine-canagliflozin?ref=fdaweb.com) says. “Collectively, these newly identified effects of canagliflozin on heart and kidney disease show significantly enhanced benefit of this medicine. Safety information from recent clinical trials also suggests that the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored. Based upon these considerations, we have concluded that the Boxed Warning should be removed. The amputation risk with canagliflozin remains and is still described in the *Warnings and Precautions* section of the prescribing information.”