SUMMARY: In April 2015 the results of the “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)” trial for for AstraZeneca’s relatively new diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCI extended-release) were discussed recently by an FDA Advisory Committee panel of medical experts.
From the “Minutes for the April 14, 2015 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)”, from which we get this information:
The majority of the committee (14 members) voted that changes should be made to the saxagliptin labeling to add new safety information, including potential increased risk of heart failure, all-cause mortality, decreased renal function, and acute pancreatitis based on the safety findings from the SAVOR trial. The committee further specified that labeling should communicate the potential increased risk for heart failure in patients with a previous history of heart failure and decreased renal function. The majority of the committee agreed that restriction of distribution is not needed. One member of the committee voted to withdraw saxagliptin from the market because SAVOR did not demonstrate a cardiovascular benefit. The committee did not recommend any additional studies….
We are watching to see whether the FDA will follow the advice given at this April 2015 Advisory Committee meeting and mandate that AstraZeneca revise the drug labels for Onglyza and Kombiglyze XR to warn about the increased risks of side effects.
In addition, we are investigating cases of patients who developed heart failure after using the Type 2 diabetes drugs Onglyza and Kombiglyze XR.[Read this article in full at original source]
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