FDA Revises Label of Diabetes Drug: Includes Updates on Bone Fracture Risk & New Info on Decreased Bone Mineral Density

The Food and Drug Administration (FDA) has strengthened the 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. Bone mineral density relates to the strength of a person’s bones. To address these safety concerns, FDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels. Health care professionals should consider factors that contribute to fracture risk prior to starting patients on canagliflozin. Patients should talk to their health care professionals about factors that may increase their risk for bone fracture. Patients should not stop or change their diabetes medicines without first talking to their health care professional.
http://www.fda.gov/Drugs/DrugSafety/ucm461449.htm