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Onglyza (saxagliptin) is a popular type 2 diabetes treatment that was approved by the FDA in 2009. The drug, manufactured by AstraZeneca, falls under a class of drugs called Selective Dipeptidyl Peptidase-4 Inhibitors (DPP-4 inhibitors).

Onglyza is used to help control high blood sugar in patients with type 2 diabetes. Onglyza works through the following process: Incretin is a hormone that your body makes, and it tells your body to release insulin after you eat which lowers blood sugar levels. When your body makes incretin, DPP-4 removes it. This is normal for people without diabetes, but people with type 2 diabetes do not make enough incretin.

This is where a DPP-4 inhibitor like Onglyza can help, because when a DPP-4 inhibitor is used, it allows incretin that is made within your body to remain in your body longer. Because incretin remains in your body longer, it triggers the release of insulin, which lowers your blood sugar level. Recently, however, Onglyza has been linked to an increased risk of heart failure and severe joint pain.

Because of the link between Onglyza and heart failure, a study of over 16,000 patients who took Onglyza was performed in 2015. This study was reviewed by the FDA and led them to state that the risk of heart failure when taking Onglyza is valid. Additionally, though the study did not suggest a higher risk of death, there was a higher risk of hospitalization due to heart failure in those patients who took Onglyza.

As a result, an FDA panel in April 2015 voted to require AstraZeneca to put a warning on its label that it can create a possible increased risk for heart failure. This warning, called a “black box” warning, is the most serious warning a drug can have on its label.

Because there is a possibility that Onglyza and other DPP-4 inhibitors can cause severe joint pain, the FDA issued a safety communication in August 2015 warning the public that this was a possible side effect of taking DPP-4 inhibitors. The FDA stated that they had received adverse reports of severe joint pain when taking Onglyza, and noted that after they stopped taking the DPP-4 inhibitor, their symptoms were relieved. The FDA went on to suggest that, when appropriate, doctors should discontinue use of DPP-4 inhibitors in patients suffering from those side effects.