Alerts

Omalizumab (Xolair®) - Ongoing Safety Review Update

July 16, 2009

Interim analysis of safety data from a large, ongoing, observational trial investigating the long-term safety and efficacy of omalizumab in patients with moderate to severe asthma (EXCELS trial) revealed a potential increased risk of adverse cardiovascular and cerebrovascular events in patients receiving omalizumab. Adverse effects included ischemic heart disease, cardiomyopathy, heart failure, rhythm abnormalities, pulmonary hypertension, thromboembolic and thrombophlebitic events.

FDA is not recommending labeling changes or alterations to patient treatment until a complete analysis of the EXCELS data is available. Providers and patients should be aware of these new safety findings and weigh the risks and benefits of omalizumab treatment.

Omalizumab is a humanized anti-IgE monoclonal antibody for patients 12 and older with moderate to severe allergic asthma that is poorly controlled with inhaled corticosteroids.

More information on this topic is available at the following links.

MedWatch Alert
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm172218.htm
Press Release July 16, 2009
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172406.htm

Updated
July 16, 2009; University of Utah, Drug Information Service.
Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.