Canagliflozin: Drug Safety Communication – New Information on Bone Fracture Risk and Decreased Bone Mineral Density


ISSUE: 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. 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.

FDA is continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empaglifozin (Jardiance, Glyxambi, Synjardy), to determine if additional label changes or studies are needed. Health care professionals and patients are urged to report side effects involving canagliflozin or other SGLT2 inhibitors to the FDA MedWatch program.

RECOMMENDATIONS: 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. Additional information for Health Care Professionals:

  • Bone fractures have been seen in patients taking the type 2 diabetes medicine canagliflozin.
    • Fractures can occur as early as 12 weeks after starting canagliflozin.
    • Canagliflozin has also been linked to decreases in bone mineral density at the hip and lower spine.
    • Consider factors that contribute to fracture risk prior to initiating canagliflozin.
    • Counsel patients about factors that may contribute to bone fracture risk.