The Prescribing Information has always contained warnings about a possible risk of bone fractures, but the FDA is adding a new Warnings & Precaution to confirm that bone fractures are more common in patients on Invokana than a placebo.
According to the FDA:
“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.”
The FDA has also added warnings about decreased bone mineral density after a 2-year study involving 714 elderly patients showed that Invokana caused more bone loss in the hip and spine than a placebo. Higher doses were linked to more bone loss.
The FDA has been investigating the link between Invokana and bone loss for years. In 2013, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) warned (PDF) about higher rates of bone fractures observed during clinical trials. Those fractures primarily occurred in the spine and upper limbs with minor trauma.
Invokana belong to one of the newest class of diabetes drugs, SGLT2-inhibitors. The FDA is still evaluating the risk of bone fractures with other drugs in this class, including Farxiga, Xigduo XR, Jardiance, Gylxambi, and Synjardy.
This is also the second time the FDA has issued a warning for Invokana in 2015. In May, the agency issued a Safety Communication to warn about the risk of diabetic ketoacidosis, a life-threatening condition involving too much acid in the bloodstream.
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