QuoteThe asthma drug Xolair is associated with a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems, though the extent of increased risk is unclear, the U.S. Food and Drug Administration said on Friday.
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July 16, 2009 -- The FDA is reviewing a possible link between the asthma drug Xolair and an increased risk of heart and cerebrovascular disorders.
Since the FDA investigation is still under way, the agency is not telling doctors to stop prescribing Xolair and is not recommending any changes to the prescribing information for Xolair.
The FDA is looking at interim results of an ongoing study of 5,000 patients with allergic asthma who take Xolair and 2,500 asthmatics who do not take Xolair.
Interim data, submitted by Xolair's manufacturer, Genentech, shows a disproportionate increase in heart and cerebrovascular events in patients treated with Xolair, compared to those who were not given the medication.