FDA Warns of Fracture Risk with Diabetes Drug Canagliflozin

By Kelly Young

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The type 2 diabetes drug canagliflozin will carry a stronger label warning about the increased risk for bone fracture and decreased bone mineral density, the FDA announced on Thursday. Canagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor marketed as Invokana and Invokamet.

Fractures have been observed as soon as 12 weeks after starting the drug and have generally been caused by low-trauma events. The FDA says clinicians should consider a patient's fracture risk before prescribing canagliflozin and should counsel patients about fracture risk factors.

In addition, a postmarketing trial of over 700 older adults found decreased bone mineral density at the lower spine and hip in patients taking canagliflozin versus placebo after 2 years.

The agency is investigating whether other SGLT2 inhibitors also pose an increased fracture risk.