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Friday, July 17, 2009
FDA Reviews Safety of Asthma Drug Xolair
The U.S. Food and Drug Administration has announced a safety review of Xolair (omalizumab), a drug used to treat moderate-to-severe persistent asthma in adults and adolescents.
Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The manufacturer’s long term evaluation study’s interim results have suggested an association between using Xolair and these adverse events. The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.
The Early Communication is part of the FDA’s commitment keep the public informed about its ongoing safety reviews of drugs. Though the review focuses on potential adverse events, the FDA is not advising a change in prescribing or use of the drug at this time.
For more information please see:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172399.htm
Labels: Asthma, FDA, Genetech, heart attack, heart failure, heart rhythm, stroke, Xolair
posted by
Jessica
at
7:05 AM
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