Update Black Box Warning Label On Invokana: FDA asks J&J to Step-up The Process

  • FDA BLACK BOX WARNING

The U.S. Food and Drug Administration (FDA) has warned the manufacturers of Invokana, Invokamet, and Invokamet XR, which are drugs prescribed for treating Type 2 diabetes, to speed track the process to include a Black Box Warning Label to warn about the increased risk of leg and foot amputations.

In 2016, the product labels were updated to reflect acute kidney disorder after taking Invokana following FDA's order. In 2017, the FDA issued a similar notice to Johnson & Johnson to alert the patients about the risk of amputations of the leg and foot. Unfortunately, more than 1,000 patients underwent leg amputation after taking Invokana, and related lawsuits have been filed against J&J and its subsidiary Janssen.

Invokana injury lawsuits are mounting in the consolidated multidistrict litigation (MDL) in the U.S. District Court, District of New Jersey (MDL No: 2750), and the first of Invokana amputation trial is expected to begin in September 2018.

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