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FDA warns diabetes drugs may increase risk of bone fractures
It wasn’t until a couple of months ago that the of SGLT2 inhibitors like Invokana / Farxiga / Jardiance causing diabetic ketoacidosis, a medical condition characterized by lack of insulin in the body. The news isn’t so good for Invokana as the FDA has strengthened the warning for canagliflozin (Invokana, Invokamet), a type 2 diabetes medication. There have been reports that the drug increases the risk of bone fractures as its mechanism of action decreases the bone mineral density. This has prompted the federal agency to strengthen the warning for the drug by adding a “WARNING AND PRECAUTION” section and revising the text for “ADVERSE REACTIONS”. Canagliflozin is a diabetes medicine that is prescribed along with a special diet and exercise regimen in order to lower the blood sugar in adults with type 2 diabetes. It belongs to a new class of diabetes medicine called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin can be found as a single-ingredient drug under the brandname Invokana or in combination with another diabetes medication under the brand name Invokamet (metformin). The drug has been found to decrease the bone mineral density of a person which weakens a person’s bones and increases the risk for fractures. What is ketoacidosis and how can canagliflozin cause it? It is known that insulin moves glucose into cells all over the body but insulin also acts as a signal for the body to increase fat and protein synthesis in fat cells and other tissues. If a healthy person without diabetes goes a long time without eating, ketones act as an important source of energy. When you’re not eating, insulin levels in the blood fall which signals your body to start breaking down fat into fatty acids and protein into amino acids. A further step when insulin levels remain low is for the body to remove certain amino groups and further break down fatty acids in order to create ketone bodies. Since SGLT-2 inhibitors affect glucose levels while leaving insulin levelsalone, it is possible that a diabetes sufferer receiving SGLT-2 inhibitor medication to keep on producing ketones even when glucose levels are low. This condition leads to ketoacidosis and it was in two diabetes patients who had taken SGLT-2 inhibitor medication. The FDA is on the lookout for other adverse side effects caused by drugs from the SGLT-2 inhibitor class which include dapagliflozin (Farxiga, Xigduo XR) and empaglifozin (Jardiance, Glyxambi, Synjardy). Health professionals have been urged to report any adverse side effects related to the SGLT-2 inhibitor class to the FDA MedWatch program. Another recommendation for healthcare professionals is that they should consider all risk factors that may contribute to fracture risk before a patient begins taking canagliflozin. Patients are advised to talk to their healthcare professionals about the risk of bone fracture as well. In under no circumstance should patients change or stop taking the prescribed diabetes medication withoutconsulting with their health care professional first.

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