FDA Early Communication on Safety of Xolair
FDA is evaluating safety findings known at this point from an ongoing study of Xolair (omalizumab). Xolair is approved for use by people 12 years of age and older with moderate to severe asthma who react to an airborne allergen year-round and whose symptoms are not controlled well with inhaled corticosteroids.
The risk: These interim findings suggest an increase in adverse events involving the blood vessels of the heart or brain (cardiovascular or cerebrovascular events) in people treated with Xolair compared to another group of people not given the drug.
This type of communication (early communication) is part of FDA’s effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion.
Recommendations:
* Do not stop taking Xolair without the advice of your health care professional.
* Talk with your health care professional about the risks and benefits described in the prescribing information for Xolair, as well as the new information from the ongoing study, called EXCELS.
via FDA’s MedWatch Safety Alerts: August 2009.
Short URL: http://www.openaccesshealthcare.com/?p=73
Posted by admin
on Aug 2 2009. Filed under Recall Alerts.
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