Bone Fracture, Density Warning Issued for SGLT2 Inhibitor
The Food and Drug Administration (FDA) has issued another warning for canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, regarding the risk for bone fractures with new information about decreased bone mineral density.
Canagliflozin is indicated for use with diet and exercise to improve glycemic control in adults with type 2 diabetes; it is present as a single ingredient and as a combination with metformin. A new Warning and Precautions section has been added and the Adverse Reactions section revised to reflect the safety risks.
The FDA recommends healthcare professionals to consider factors that affect the risk of fracture prior to prescribing canagliflozin for patients. Fractures have occurred as early as 12 weeks after starting therapy and canagliflozin has been associated with decreases in bone mineral density at the hip and lower spine.
There is also an ongoing evaluation for the risk of bone fractures with other SGLT2 inhibitors to evaluate the need for drug label changes or additional studies.
For more information call (855) 543-3784 or visit FDA.gov.