FDA Warning: Type 2 Diabetes Treatment Decreases Bone Density

Use of diabetes therapy may increase the risk of bone fracture.

The FDA recently issued an additional warning for the type 2 diabetes drug canagliflozin (Invokana, Invokamet). The warning is related to the increased risk of bone fractures and additional information about decreased bone mineral density.

Following the warning, physicians should consider risk factors for patients who are currently taking or considering taking Invokana/Invokamet regarding their bone density. Patients should talk to their health care professionals about factors that may increase their risk for bone fracture and not discontinue treatment prior to speaking with their respective physician.

Invokana/Invokamet is used in combination with diet and exercise to treat type 2 diabetes by lowering blood sugar. It belongs to the sodium-glucose contransporter-2 (SGLT2) inhibitor drug class. When left untreated, type 2 diabetes can have serious consequences for patients including blindness, nerve and kidney damage, and heart disease. The medication works to lower blood sugar by removing sugar in the body through the urine.

Information about the risk of bone fractures was already made available to patients under the Adverse Reactions section of the drug label. Based on information gathered from new clinical trials regarding bone fractures, the FDA has added a new Warning and Precaution to the updated drug labels.

Additionally, the new data confirm the finding that fractures occur more frequently with Invokana/Invokamet than with the placebo, an inactive treatment. Patients can experience fractures as early as 12 weeks after starting treatment with the medication. In clinical trials, the various causes of fractures were mild in nature, such as falling from no more than standing height, indicating a severe decrease in bone density.

The FDA has also issued a warning regarding the decrease in bone mineral density, following a trial where elderly patients had greater loss of bone mineral density at the hip and lower spine than a placebo.