Johnson & Johnson Asked to Warn About Invokana Limb Amputation


The U.S. Food and Drug Administration (FDA) has recently asked the Johnson & Johnson Co. to step up its efforts to warn the public regarding the increased risk of Invokana limb amputation.

Invokana, a medication used to treat type-2 diabetes, is part of a class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. A growing number of patients report problems with Invokana limb amputation.

Also included in this class are Jardiance, Farxiga, Invokamet, and Invokamet XR. The latter two contain the same active ingredient as Invokana—canaglifozin—with metformin, a more traditional diabetic medication.

The FDA is requiring a label change of Invokana, Invokamet, and Invokamet XR that includes a black box warning. Black box label warnings are reserved for drugs with the potential for very serious adverse side effects such as Invokana limb amputation. Recent clinical trials were completed that had monitored patients taking Invokana, Invokamet and Invokamet XR against a control group taking a pill without an active ingredient.

Upon conclusion of these trials and configuration of the results, it was found that those ingesting the SGLT2 inhibitors were twice as likely to have had to undergo Invokana limb amputation of toes, feet, and legs. The FDA sent out a safety announcement in May 2017 and posted the trial conclusions on its website.

Certain patients taking Invokana, Invokamet,…