FDA Investigating Heart Failure Risk Linked To Saxagliptin
On Tuesday, the Food and Drug Administration (FDA) announced it is investigating a possible increased risk for heart failure associated with the diabetes drug Saxagliptin, manufactured by Bristol-Myers Squibb and AstraZeneca and marketed as Onglyza and Kombiglyze XR. The FDA has requested full data from the results of a recent clinical trial assessing the cardiovascular safety and efficacy of many current medications used to treat type 2 diabetes, including Saxagliptin (SAVOR trial). The FDA intends to further investigate the 27% increased risk of hospitalization for heart failure among patients taking the Saxagliptin reported in the study. The findings were first reported in August of 2013 at the European Society of Cardiology meeting and subsequently published in the New England Journal of Medicine.
Bristol-Myers Squibb and AstraZeneca are expected to submit the requested data by early March, but did not indicate when they expected their review of the data to be completed.
The FDA noted that their investigation into Saxagliptin side effects is part of a broader evaluation of all type 2 diabetes drugs and potential heart risks, which was prompted by the cardiovascular risks discovered to be associated with the diabetes drug Avandia (rosiglitazone). The FDA advised that patients should not stop taking Saxagliptin and should speak with their doctors if they have any concerns.
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