Invokamet regulatory update

FDA strengthened the warning of the increased risk of bone fractures for Type II diabetes drugs Invokana canagliflozin and Invokamet canagliflozin/metformin IR from Johnson & Johnson. The agency revised the adverse reaction sections and added a new warning and precaution to their labels based on updated data about bone fractures from several clinical trials that showed that fractures can occur as early as 12 weeks after starting canagliflozin. Information about the risk of decreased bone mineral density was added to the adverse reactions section of the label based on data from a clinical trial in 714 elderly subjects that showed that canagliflozin -- a sodium-glucose cotransporter 2 (SGLT2) inhibitor -- caused greater bone mineral density loss at the hip and lower spine vs. placebo. ...