FDA strengthens warning on bone risks with canagliflozin

FDA is strengthening its warning about the increased risk of bone fractures and added new information about reduced bone mineral density for the type 2 diabetes drug canagliflozin. FDA has added a new warning and precaution and revised the adverse reactions section of the drug's label.

FDA is strengthening its warning about the increased risk of bone fractures and added new information about reduced bone mineral density for the type 2 diabetes drug canagliflozin. FDA has added a new warning and precaution and revised the adverse reactions section of the drug's label. Canagliflozin is sold as a single-ingredient product under the brand name Invokana and also in combination with metformin under the Invokamet. The agency is still assessing the risk of bone fractures with other SGLT2 inhibitors, including dapagliflozin and empagliflozin. Any adverse events involving canagliflozin or other SGLT2 inhibitors should be reported to the FDA Medwatch program. FDA recommends that prior to starting patients on canagliflozin, health care professionals consider factors that contribute to fracture risk.