The FDA has strengthened the warning for the type 2 diabetes drug canagliflozin (Invokana, Invokamet) in relation to the increased risk of bone fractures, while also adding new information about decreased bone mineral density. The FDA has added a new warning and precaution and revised the adverse reactions section of the Invokana and Invokamet drug labels while continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class. Recommendations and factors to consider for health care professionals include:

• Consider factors that contribute to fracture risk prior to starting patients on canagliflozin.

• Bone fractures have been seen in patients taking the type 2 diabetes drug canagliflozin.

• Fractures can occur as early as 12 weeks after starting canagliflozin.

• Cangliflozin has been linked to decreases in bone mineral density at the hip and lower spine.

• Counsel patients about factors that may contribute to bone fracture risk.

• Report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event reporting program at www.fda.gov/MedWatch/report.

Source: FDA website. Invokana and Invokamet (canagliflozin): Drug safety communication – new information on bone fracture risk and decreased bone mineral density. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm461876.htm. Posted September 10, 2015. Accessed September 11, 2015.