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FDA Warning: Invokana Can Increase Risk of Bone Fracture

Bone mineral density at hip and lower spine may also decrease.

The U.S. Food and Drug Administration (FDA) published a safety announcement about one of the side effects of Invokana: it may increase risk of bone fractures and decrease bone mineral density in T2DM patients. This new warning and precaution were added in the adverse reactions section of the Invokana and Invokamet drug labels.

Canagliflozin, which is the generic name of Invokana, is known as one of SGLT-2 inhibitors. SGLT-2 inhibitors is oral diabetes medications, which help people lower blood sugar levels by removing sugar through the urine. Other SGLT-2 medications include dapagliflozin (Farxiga) and empaglifozin (Jardiance). This drug was approved by the FDA in 2013, and other side effects include increasing urinary tract infection, fungal infections of the genital area, ketoacidosis, etc.

In the post-marketing safety evaluation, 714 elderly participants were tested for changes to bone mineral density over two years. The results showed people starting the drug had fractures as early as 12 weeks into treatment. Canagliflozin caused loss of bone mineral density at the hip and lower spine. This clinical trial confirmed fractures happened more frequently in patients with canagliflozin, especially in post-menopausal women.

The FDA will continue to investigate the association between other SGLT-2 inhibitors and the risk of bone fractures. Health care professional should be aware of this warning and talk to patients who are at high risk of bone fracture.

Practice Pearls:

  • The FDA added a new warning and precaution in Invokana; it may increase risk of bone fractures and decrease bone mineral density in T2DM patients.
  • Clinical trials showed Canagliflozin caused loss of bone mineral density at the hip and lower spine.
  • Patients who want to start Invokana or had high risk of bone fracture should talk to their health care professionals before taking Invokana.
  • The FDA will update label to include new data on the low annual incidence of bone fracture and risk of decreased bone mineral density.

FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density. Sep 10, 2015. http://www.fda.gov/Drugs/DrugSafety/ucm461449.htm