Invokana (canagliflozin) was developed by Mitsubishi Tanabe Pharma in 2012 and is marketed by Janssen Pharmaceuticals, a division of Johnson & Johnson. In March of 2013 the FDA approved it for treatment of Type 2 Diabetes. It was the first SGLT2 inhibitor to be approved in the U.S.
Shortly thereafter, the FDA began receiving adverse event reports from patients who were using Invokana. In a May 2015 Safety Communication the FDA warned that canagliflozin may lead to ketoacidosis, a serious medical condition that could result in a coma or even death. According to the FDA, a search of its database identified 20 cases of acidosis or, ketoacidosis, in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. All of these patients required emergency room visits or hospitalization to treat the ketoacidosis.
The Safety Communication went on to state that since June 2014, additional reports of patients treated with SGLT2 inhibitors developing ketoacidosis had been received. The FDA stated in the Safety Communication that, “we are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.”