- The FDA issues a warning that type 2 diabetic patients taking drugs called sodium-glucose contransporter-2 (SGLT-2) inhibitors to lower their blood sugar may have increased risk of developing ketoacidosis, a serious condition characterized by the buildup of acids, called ketones, in the blood that can be life-threatening if untreated for an extended period. It is caused by an insulin deficiency which forces cells to burn fat for energy instead of glucose which produces ketones.
- The agency is investigating the issue to determine if the safety risk warrants changes to the labeling of currently approved medications. There were 20 reported cases of ketoacidosis in the period from March 2013 to June 6, 2014, all of which required emergency room visits or hospitalization.
- SGLT-2 inhibitors cleared for sale in the U.S. are Johnson & Johnson's (JNJ) Invokana (canagliflozin) and Invokamet (canagliflozin/metformin); AstraZeneca's (AZN -1.4%) Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin/metformin); Eli Lilly (LLY -0.5%) and Boehringer Ingelheim's Jardiance (empagliflozin) and Glyxambi (empagliflozin/linagliptin).