FDA Lifts Amputation Risk Boxed Warning From Canagliflozin

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On Wednesday, the U.S. Food and Drug Administration (FDA) issued a report indicating that it has lifted a Boxed Warning about amputation risk from type 2 diabetes drug canagliflozin, marketed under the brand names Invokana, Invokamet, and Invokamet XR.

The Boxed Warning was required by the FDA in 2017 after it found that the risk of amputations was very serious over the potential benefit of canagliflozin, which was initially approved to lower blood sugar in adults with type 2 diabetes. The current lift is based on a review of new data from three clinical trials, which also demonstrated additional heart and kidney-related benefits, leading to additional approved uses.

The recent clinical trials also note that the risk of amputation increases with canagliflozin but is lower than previously described when monitored appropriately. The information is removed from the Boxed Warning, but it is still described in the Warnings and Precautions section of the prescribing information.

The FDA also advised that health care professionals and patients should continue to recognize the importance of preventative foot care and consider the risk factors when choosing antidiabetic medicines. 

In June, the consumer rights advocacy group, Public Citizen, filed a petition with the FDA asking to add stronger warning labels for the type 2 diabetes drugs, stating that the agency must explicitly oppose the use of these drugs for patients with Type 1 diabetes as the drugs are linked to serious and potentially life-threatening cases of diabetic ketoacidosis.

Several Invokana lawsuits were filed in courts nationwide against the manufacturer Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc., most of which have been settled.

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