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WASHINGTON (AP) - The government ordered stronger label warnings for an injected asthma medication Wednesday because of reports some patients taking the drug, marketed as Xolair, had suffered a delayed and potentially life-threatening reaction known as anaphylaxis.
A patient experiencing anaphylaxis might have trouble breathing, feel tight in the chest, have swelling in the mouth and throat, suffer dizziness or feel faint, or have itching and hives.
The risk of anaphylaxis was known when Xolair, also called omalizumab, was approved as an asthma treatment in 2003. But the Food and Drug Administration ordered the drug manufacturer, Genentech, Inc., to strengthen the label warnings because of reports of patients having a delayed reaction of anaphylaxis or reacting to a subsequent dose even when they had no problems after a first dose.
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