Safety Alerts & Recalls

What does this mean?

At this time, the FDA has not made any conclusions about these early findings from the EXCELS study. The FDA is advising patients to continue treatment with Omalizumab. However, it is a good idea to follow up with your doctor at your next appointment to review the benefits and risks of treatment with Omalizumab, including this new safety information from the ongoing EXCELS study that may suggest a risk of cardiovascular and stroke related adverse events. For most patients, the benefits of Omalizumab will continue to outweigh the risks.

Omalizumab (marketed as Xolair): Early FDA Communication about an Ongoing Safety Review

The FDA is evaluating early safety findings from an ongoing clinical research study of Xolair (omalizumab) titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS). These early study findings suggest a greater risk of cardiovascular and stroke problems in patients treated with Xolair compared to the control group of patients not given the drug. Some of the cardiovascular problems reported during the study include ischemic heart disease, arrhythmias (abnormal heart beats), heart failure, pulmonary hypertension, and clotting events. The FDA will follow up with additional information once the evaluation of the EXCELS study is complete.

Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to airborne allergens, and whose symptoms are not well controlled with inhaled corticosteroids.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-07-16
Last Updated: 2009-12-05

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