Fracture Risk Added to Diabetes Drug Label

Type 2 diabetes drug canagliflozin (Invokana, Invokamet) can decrease bone strength and increase the risk of fractures, the FDA is warning health care professionals.

To reflect these concerns, the FDA has strengthened the “Warning and Precaution” and revised the “Adverse Reactions” sections of the Invokana and Invokamet drug labels.

The FDA is also evaluating the risk of bone fractures with other sodium-glucose cotransporter-2 (SGLT2) inhibitors, including dapagliflozin (Farxiga, Xigduo XR) and empaglifozin (Jardiance, Glyxambi, Synjardy), to determine whether additional label changes or studies are needed across this type 2 diabetes drug class.

In the meantime, health care professionals and patients should report related side effects of canagliflozin or other SGLT2 inhibitors to the FDA’s MedWatch program.

Before recommending canagliflozin treatment, health care professionals should consider factors that contribute to fracture risk and counsel patients about them.

Bone fractures have occurred as early as 12 weeks after starting canagliflozin, the FDA reports. The type 2 diabetes drug has also been linked to decreased bone mineral density in the hip and lower spine.

Still, patients should not stop or change their canagliflozin regimen without first speaking with their health care professional.