FDA panel wants heart failure risk on AstraZeneca drugs
WASHINGTON - Federal health advisers say labels on AstraZeneca's Onglyza and another related diabetes drug should carry new information about a possible association with heart failure and death.
The Food and Drug Administration's panel of diabetes experts voiced concern about data suggesting patients taking Onglyza and Kombiglize are at greater risk of hospitalization due to heart failure and dying. The panel voted 14-1 that that information should appear on the drugs' prescribing labeling. Yet the panelists also said complicating factors make it difficult to assess whether the risk is real or a statistical fluke.
The panel voted 13-1, with one abstention, that the drugs' heart safety profile was acceptable.
The FDA convened the meeting to review data from a large, multi-year study of Onglyza and Kombiglize's heart safety. The agency began requiring such studies in 2008.