On September 10, 2015, the U.S. Food and Drug Administration (FDA) announced that it is strengthening the warning on Invokana (canagliflozin) and Invokamet to reflect the risk of bone fracture and decreased bone mineral density associated with using the drugs. Invokana is used to treat Type 2 diabetes. It is in a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. The risk of bone fracture and decreased bone density associated with other SGLT2 inhibitors is still being studied.
New Data Leads to Stronger Warning
It was already known that Invokana use may lead to bone fracture and that risk was mentioned in the Adverse Reactions section of the label. Now, clinical trials have confirmed the danger. The new bone fracture warning comes after evaluation of pooled data from nine clinical trials. The FDA now says that bone fractures can occur as soon as 12 weeks after starting Invokana.
The decreased bone mineral density warning is the result of a postmarketing safety trial that the FDA required when it approved the drug. The FDA says that Invokana has been linked to decreased bone density in the hip and lower spine.
The FDA is advising doctors to consider the bone fracture risk before prescribing Invokana and to talk to patients about the danger. If you are already taking Invokana you should talk to your doctor about the risk, but do not stop taking the drug without talking to your doctor first and coming up with an alternate plan for controlling your blood sugar.