FDA Issues Bone Fracture Warning for Invokana, Invokamet

September 10, 2015 — Invokana and Invokamet can decrease bone density and increase the risk of bone fractures, according to a Safety Communication from the FDA.

The Warnings & Precaution information has included a possible risk of broken bones since Invokana was approved. The FDA is adding new warnings to confirm that studies have found higher rates of bone fractures among patients on Invokana than those on a placebo.

According to the FDA, bone fractures can occur early in treatment after only minor trauma:

“Fractures were observed as early as 12 weeks after treatment initiation, and were more likely to be low trauma (e.g., arising after falls from no more than standing height) and affect the upper extremities.”

These findings were confirmed in a 2-year study involving 714 elderly patients on Invokana or a placebo. Researchers found significantly more bone loss in the hip and spine of patients on Invokana than a placebo, with higher doses associated with more bone loss.

Evidence linking Invokana and bone injuries has been growing for years. In clinical trials, researchers observed higher rates of fractures — primarily upper-limb and spinal fractures after minor trauma. The FDA was warned (PDF) about these findings in 2013 by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).

The FDA is still investigating whether the risk of bone fractures includes other diabetes drugs in the same class as Invokana — SGLT2-inhibitors like Farxiga, Xigduo XR, Jardiance, Gylxambi, and Synjardy.

In May, the FDA issued a Safety Communication to warn about diabetic ketoacidosis (too much acid in the bloodstream), a potentially deadly side effect of Invokana and other SGLT2 inhibitors.

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