July 16, 2009
Xolair safety review updateThe FDA is evaluating interim safety findings from the ongoing EXCELS study of Xolair (omalizumab subcutaneous injection, from Genentech and Novartis), that suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug. The FDA is not recommending any changes to the Xolair prescribing information and is not advising patients to stop taking Xolair at this time. Until the evaluation of the EXCELS (Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma) study is completed, healthcare providers and patients should be aware of the risks and benefits described in the prescription information as well as the new information from the ongoing EXCELS study.
Xolair is indicated for the management of moderate to severe persistent asthma in patients ≥12 years of age with a (+) skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled by inhaled corticosteroids.
For more information visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm172218.htm.