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Health Canada Investigating Reports of Increased Cardiovascular Risks With Omalizumab OTTAWA -- August 13, 2009 -- Health Canada is informing healthcare professionals and Canadians that it is conducting a safety review of the potential association between the asthma drug omalizumab (Xolair) and an increased risk of cardiovascular problems. The review comes in light of the interim findings of an ongoing study in the United States to assess the long-term safety profile of omalizumab. The interim data suggest a disproportionate increase in cardiovascular problems among patients treated with omalizumab relative to patients not treated with the drug. The problems reported include: heart attacks, abnormal heart rhythms, heart failure, fainting, ministrokes, and blood clots. In Canada, omalizumab is indicated for the treatment of asthma in people 12 years of age and older who have moderate to severe persistent asthma, who react to airborne allergens, and whose symptoms are not adequately controlled with inhaled corticosteroids. The study, Evaluating the Clinical Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma (EXCELS), is an observational study of approximately 5,000 patients who use omalizumab and a control group of approximately 2,500 patients who do not. Study participants are 12 years of age and older with moderate to severe persistent asthma and who have an allergy to an airborne substance, such as pollen or spores. The final results of the 5-year study are expected in 2012. At this time, Health Canada recommends that patients should not stop taking omalizumab without first speaking to their doctor. Patients should contact their healthcare professional if they have any concerns about the medicines they are taking. Health Canada has not concluded that there is a relationship between omalizumab and cardiovascular problems. The Department is assessing the interim findings of this ongoing study as well as working with the market authorisation holder, Novartis Pharmaceuticals Canada, to obtain further information. Should new safety information emerge from the review, Health Canada will inform Canadians and healthcare professionals and take appropriate action as necessary. SOURCE: Health Canada E-mail this page to a friend or colleague! To print, use this version