In May 2016, the FDA issued an initial safety alert informing the public that taking Invokana or Invokamet can increase the need for a leg or foot amputation. Then, about a year later, the agency issued a second safety warning, adding that the risk of amputation when taking Invokana was nearly double the risk of diabetes patients who did not take the drug. As a result, the FDA required a black box warning be added to the drug label.

Many of the Invokana lawsuits against Janssen accuse the company of failing to warn them of the higher risk of amputation. They are seeking compensation for the costs of treatment, pain and suffering caused by amputations, and other related expenses.

In August 2018, the FDA issued a warning about a newly discovered serious side effect of Invokana and other SGLT2 inhibitors called Fournier’s gangrene (also known as necrotizing fasciitis of the perineum). This rare condition is caused by an infection in and around the genitals in both males and females, and it can lead to serious damage to the body and even death.