AstraZeneca, Boehringer Ingelheim, Eli Lilly, J&J, Mitsubishi Tanabe Pharma regulatory update

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began a review of Type II diabetes drugs containing canagliflozin, dapagliflozin and empagliflozin -- all sodium-glucose cotransporter 2 (SGLT2) inhibitors -- to evaluate the risk of diabetic ketoacidosis. As of May 19, there were 101 cases of diabetic ketoacidosis in patients treated with SGLT2 inhibitors reported worldwide, according to EMA. The agency said all cases were serious and some required hospitalization.

In May, FDA issued a safety communication warning that the SGLT2 inhibitors may lead to diabetic ketoacidosis. The agency said it will continue to monitor the events and will consider label changes if necessary. ...