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FDA requires J&J to include boxed warning on diabetes drugs

The FDA has required Johnson & Johnson to include in the package inserts of its diabetes drugs Invokamet, Invokamet XR and Invokana a boxed warning regarding the risk of leg and foot amputations from taking the active ingredient canagliflozin. A safety analysis of a study conducted last year showed an increased risk of lower-limb amputation, mainly of the forefoot and toe, in patients with a high risk of cardiovascular events.

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