The U.S. Food & Drug Administration told Johnson & Johnson to include new warning labels on its diabetes drug Invokana, as well as variations of the drug sold under the brand Invokamet and Invokamet XR.
This latest requirement from the federal regulatory agency comes on the heels of other legal troubles faced by the corporation. Just two weeks ago, a jury awarded $110 million to a woman in Missouri who claimed that that J&J’s popular talcum powder products cause ovarian cancer.
The new black box warning informs individuals that they could face a higher risk of needing an amputation after taking Invokana (known generically as canagliflozin) or one of its derivatives. This comes from two large clinical trials, both of which demonstrated that the diabetes medication causes a significantly increased risk of leg and foot amputations. Black box warnings are the highest level of required warning for drugs manufactured and sold in the U.S.