EMA starts review of SGLT2i to evaluate the risk of diabetic ketoacidosis
The European Commission has requested the review following reports of 101 cases of diabetic ketoacidosis in patients treated with SGLT2i for T2DM in the worldwide EudraVigilance database (exposure ~500,000 patient years). The Pharmacovigilance Risk Assessment Committee (PRAC) plans to provide a recommendation to the Committee for Medicinal Products for Human Use (CHMP) in October 2015. SGLT2i in scope are J&J's Invokana (canagliflozin), AstraZeneca's Forxiga (dapagliflozin) and Eli Lilly+BI's Jardiance (empagliflozin). (EMA press release, 12 June 2015) Comment: The FDA has also issued a warning of diabetic ketoacidosis for the SGLT2i class. J&J has confirmed that rare ketoacidosis cases with Invokana have been reported in T2DM. The mechanism is unknown, but diagnosis may be delayed since moderate increase in blood glucose levels are uncharacteristic |