In a Drug Safety Communication issued Tuesday, the U.S. Food and Drug Administration (FDA) said that it has requested clinical trial data to analyze the association between heart failure and saxagliptin, a Type 2 diabetes drug marketed as Onglyza and Kombiglyze XR. The agency said the review is based on a study published in the New England Journal of Medicine that “reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment.”
The manufacturer is expected to submit the clinical data by early this March, the FDA said. After that, the agency “will conduct a thorough analysis and report findings publicly.” This review is part of a broader evaluation of all diabetes drugs and their link to heart problems.
Heart-related issues are a concern when it comes to diabetes drugs, especially since patients with Type 2 diabetes have a higher risk of heart troubles. Drugs such as GlaxoSmithKline’s Avandia, for instance, have been linked to cardiovascular issues.
AstraZeneca co-developed saxagliptin with Bristol-Myers Squibb. Earlier this month, AstraZeneca bought all the rights to the drug. Saxagliptin is supposed to lower blood sugar in adults with Type 2 diabetes by increasing the amount of insulin. In Type 2 diabetics, the body does not properly use or produce insulin, leading to high levels of blood sugar.