Last week the FDA increased their warning of the increased risk between bone fractures and type 2 diabetes medications, Invokana and the combo drug Invokamet. They have revised the drug’s labels adding information about decreased bone density and the risk of hip and lumbar spine fractures. Fractures have been reported as early as 12 weeks after beginning treatment.
The FDA had already listed bone fractures as a possible side effect. However, after reviewing the results of a 2 year postmarketing study of 714 elderly patients with type 2 diabetes, they concluded that drugs containing canagliflozin, an SGLT2 inhibitor contained in Invokana and Invokamet carried a serious risk of fractures. The FDA is still evaluating whether to order studies or increase warnings on other SGCLT2 diabetes drugs such as Farxiga and Jardiance.
Approved in 2013, Invokana and Invokamet have performed well for drug manufacturer, Janssen Pharmaceuticals, Inc. earning top dollars [...]