FDA is warning about ketoacidosis and urinary tract infections associated with the relatively new class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors such as Invokana and Jardiance.
The FDA has strengthened its warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased bone mineral density.
The FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.
SGLT2 inhibitors, GLP-1 receptor agonists, inhaled insulin, extended-release treatments, and fixed-dose combination therapies are among the approaches that have emerged to treat the exploding numbers of type 2 diabetes patients.
FDA has approved once-daily dapagliflozin and metformin hydrochloride extended-release (Xigduo, AstraZeneca) (XR) for the treatment of adults with type 2 diabetes. Xigduo XR is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.