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News From the Food and Drug Administration
October 20, 2015

Diabetes Drug Poses Bone Risks

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Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;314(15):1554. doi:10.1001/jama.2015.13009

Updated labeling for the type 2 diabetes drug canagliflozin carries a stronger warning of increased bone fracture risk and new information about decreases in bone mineral density uncovered in additional clinical trial data. The warning applies to both canagliflozin, marketed as Invokana, and a fixed-dose combination of canagliflozin and the diabetes medication metformin, marketed as Invokamet (

Canagliflozin was approved in 2013 as the first in a new class of medications called sodium-glucose cotransporter 2 (SGLT2) inhibitors that lower blood glucose by acting on the kidneys to remove sugar from the body through urine. The drug is prescribed as an adjunct to diet and exercise to improve glycemic control.

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