The Food and Drug Administration (FDA) announced today that it is closely looking at possible heart related side effects associated with the use of Xolair. The interim safety report is part of the Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) study. Xolair is currently approved for use by adults and adolescents with moderate to severe persistent asthma whose symptoms are poorly controlled with inhaled corticosteroids and who test positive foe sensitivity to specific airborne allergens.

An interim safety report suggests there may be an increased number of cardiovascular and cerebrovascular adverse events in patients using Xolair compared to a group of patients not given the drug. These include ischemic heart disease, abnormal heart rhythms, heart failure, strokes, and certain types of blood clots.

The FDA is not recommending patients stop taking Xolair, but wanted to make patients and healthcare providers aware of these possible side effects. The EXCELS study will not be completed until 2012, but will report any additional findings as they become available.

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