Omalizumab May Be Linked to Cardiovascular Adverse Events

Neil Osterweil


July 16, 2009

July 16, 2009 — Results of an interim safety analysis of a clinical trial evaluating omalizumab (Xolair, Genentech/Novartis) in patients with moderate to severe asthma suggest that use of the drug may be associated with a disproportionate increase in the incidence of certain cardiovascular adverse events compared with control subjects, the US Food and Drug Administration (FDA) announced today.

The interim safety findings were from the ongoing Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) trial, indicating increases in the incidence of ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic, and thrombophlebitic events in patients treated with omalizumab compared with control subjects, FDA announced.

The FDA is not recommending changes to safety labeling for for Xolair, and clinicians do not need to take their patients off the drug.

"Until the evaluation of the EXCELS study is completed, healthcare providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events," according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.

Omalizumab, an anti-immunoglobulin E monoclonal antibody, is approved for the treatment of moderate to severe persistent asthma in adults and adolescents older than 12 years who test positive for reactivity to a perennial airborne allergen and who do not achieve adequate control of symptoms with inhaled corticosteroids.

More information is available on the MedWatch Web site.

Adverse events associated with omalizumab may be reported to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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