The U.S. Food and Drug Administration on Wednesday removed a boxed warning about increased risk of leg and foot amputations with Johnson & Johnson’s diabetes drug Invokana.
The decision is based on data from recent clinical trials that suggests that the risk of amputation, while still increased with the drug, is lower than previously attributed, when monitored appropriately, the health regulator said.
Invokana was approved in 2017 to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Reviews of new clinical data also showed the drug had additional heart and kidney related benefits, the agency said.
Invokana generated sales of $790 million in 2019, a decline of 20% from a year earlier.
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