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.
According to the FDA safety communication released, the clinical studies showed that amputations were nearly twice as common in patients who took canagliflozin versus those who received a placebo. The studies, known as CANVAS and CANVAS-R, which were conducted by Johnson & Johnson as part of a larger cardiovascular study, shared similar results. The company had been hoping that the studies would show Invokana to be safe, but instead they revealed a need for even greater caution.
This is not the first time that Invokana has been the subject of safety concerns. In the past, the diabetes drug has been the subject of a number of lawsuits due to the drug’s side effects, including the increased risk of amputation.
If your leg, foot or toe was amputated after you took Invokana or Invokamet for type 2 diabetes, you may have the right to sue the maker of these drugs, Janssen Pharmaceuticals, Inc., a Johnson & Johnson company. Find more information in the Reyes Browne Reilley site, here.