FDA Warns of Bone Fracture Risk and Lower BMD with Diabetes Drug Save

The FDA has strengthened its warnings for the type 2 diabetes drug canagliflozin (Invokana, Invokamet) and the apparent increased risk of bone fractures, and added new information about decreased bone mineral density.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet. 

FDA analyses has shown that bone fractures seen with canagliflozin can occur as early as 12 weeks after starting the drug. Canagliflozin has also been linked to decreases in bone mineral density at the hip and lower spine.  Physicians should consider factors that contribute to fracture risk prior to initiating canagliflozin and counsel patients about factors the potential increased bone fracture risk.