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Asthma Drug Xolair: Under safety review for possible cardiovascular and cerebrovascular adverse events

Posted Jul 27 2009 12:12am
From Geriatric Pharmacy Intern, Amalia Castro, PharmD(c)
Nova Southeastern University School of Pharmacy

On July 16, 2009 the U.S. Food and Drug Administration (FDA) announced to the public new findings with respect to the ongoing safety study on the asthma drug Xolair (omalizumab). These findings associate the asthma drug with an increased risk of heart attack, abnormal heart rhythm, heart failure and stroke. Xolair was approved on June 2003 to treat moderate to severe asthma in adults and adolescents (12 years of age and older) who test positive for a perennial airborne allergen, and whose symptoms are not well controlled with inhaled corticosteroids.

The ongoing observational study named Evaluating the Clinical Effectiveness and Long-term Safety in Patients with Moderate to Severe Asthma (EXCELS) began back in 2007 after the addition of a Black Box Warning to Xolair for severe anaphylaxis risk. This study is following approximately 5000 Xolair treated patients and comparing them to a control group of 2500 non-Xolair treated patients for a period of 5 years. The primary objective is to evaluate the long-term safety profile of omalizumab in patients 12 years of age and older with moderate to severe persistent asthma and who test positive for an aeroallergen.

When comparing the Xolair treated group with the control group, Xolair’s manufacturer, Genentech, reports to the FDA that there seems to be an increase in the incidence of cardiovascular and cerebrovascular events in patients being treated with the asthma drug. Genentech observed an increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in these patients.

The FDA has not made any conclusions regarding the data presented by the EXCELS study, and does not advise patients to discontinue their therapy at the moment until a through review of the recent findings is completed. Final results from this study are expected on 2012, until then, healthcare professionals and patients must be in the lookout for any results from the EXCELS study that might be associated with the risk of cardiovascular or cerebrovascular events, in addition to being aware of the risks and benefits that are associated with the use of this asthma drug. The FDA also reminds healthcare professionals and patients the importance of reporting any adverse events from the use of Xolair or any other drug by using the FDA’s MedWatch Adverse Event Reporting program online, by mail or fax.

For more information on Drug Safety please visit the FDA’s website at
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