Genentech is carrying out a five-year study so it can access the long-term safety profile of Xolair. The data suggests a disproportionate increase in certain cardiovascular and cerebrovascular problems in patients treated with Xolair compared with the control group not given the drug. The final results of the study are not expected until 21012 and the FDA pointed out that factors other than the drug could be responsible for the increase in heart attack and stroke but mandated the study as part of its post-approval process. The agency is not advising patients to stop taking Zolair and has not recommended any changes to the prescribing information.
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