The Food and Drug Administration (FDA) has approved updated safety labels for the type 2 diabetes drugs Invokana and Invokamet that include stronger warnings regarding bone fracture risk, especially among people with decreased bone mineral density. The new warnings are listed under the WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections of the drug’s label.
Invokana and Invokamet contain the active drug ingredient canaliflozin, and were approved by the FDA in 2013 and 2014, respectively. Invokamet also includes the diabetes drug metformin. The drugs are in a class of type 2 diabetes medications known as SGLT2 inhibitors. Other drugs in this class include the brand names Farxiga, Xigudo XR, Jardiance, Glyxambi and Synjardy.
Only Invokana and Invokamet carry the risk for bone fracture, though the FDA said it will evaluate bone fracture risk to determine whether warnings should be added to the safety labels of other SGLT2 inhibitors.
The updated safety labels on Invokana and Invokamet warn that bone fractures have occurred as early as 12 weeks after treatment initiation, and that doctors should consider bone fracture risk, such as low bone density, before initiating treatment in patients. The drug has also been linked to decreases in bone mineral density at the hip and lower spine. Bone fractures reported with the drugs were more likely to be from low trauma, such as falls from no more than standing height, and affect the upper extremities.
Another concerning issue with Invokana and Invokamet, which has been added to the ADVERSE REACTIONS section of the drugs’ safety labels, is that the medications can increase the risk of falls in patients within the first few weeks of treatment.