FDA Removes Boxed Warning on J&J’s Diabetes Drug Invokana

The FDA on Wednesday removed the boxed warning on Johnson & Johnson’s type 2 diabetes drug canagliflozin (Invokana, Invokamet and Invokamet XR) that had warned about the risk of leg and foot amputations.

The agency said that safety information from recent trials indicated that the risk of amputation is lower than previously thought when patients are properly monitored. However, the Warnings and Precautions section of the prescribing information will still include a warning of increased risk of amputations.

The FDA had required the boxed warning in 2017 after finding that the risk of amputations was high relative to the drug’s potential benefit for lowering blood sugar levels in type 2 diabetes patients.