FDA Panel Recommends Adding Heart Failure Risk on Onglyza Label

An advisory panel to US health regulators voted that AstraZeneca’s diabetes drug Onglyza should include new safety information about the risk of heart failure.

An advisory panel to the US Food and Drug Administration (FDA) met Tuesday to review data from a large scale cardiovascular (CV) outcomes trial that assessed if there was an effect on CV risk in patients with type 2 diabetes who were taking AstraZeneca’s Onglyza. A few days ahead of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, the agency released briefing documents expressing its concerns of an increased risk of death associated with Onglyza use.

In its briefing documents, the FDA noted that patients treated with Onglyza experienced a 27 percent increase in the risk of hospitalization due to heart failure as compared to placebo. Additionally, patients demonstrated a significant increase in the risk of death from all causes. These data resulted from the SAVOR study, conducted in type 2 diabetes patients with established CV disease or at high risk of CV disease. The study was required by the FDA, following the drug’s approval in 2009.

The panel of diabetes experts voted 14-1 that information should appear on the drug’s prescribing label. However, the members said that complicating factors make it hard to determine whether the risk actually exists or if it is a statistical accident. In a preliminary FDA review of the drug noted an increase in the death rate from all causes, and the agency said that the causes of death were often “multifactorial.” Since there was a lack in any common theme of death and the causes varied, the panelists had difficulty assessing the association.

The panel also voted 13-1, with one abstention, that the drug’s heart safety profile was acceptable.

While the FDA is not obligated to follow the advice of its advisory panels, it often times does.

Last updated: 4/14/15; 2:20pm EST

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