Due to reports of anaphylaxis, the FDA is requiring a black box warning on the label of Xolair. The black box will warn of the risk of life-threatening anaphylaxis with any dosage of Xolair. The drug is made by Genentech, and used to treat allergy-related asthma. The symptoms of anaphylaxis include chest tightness, swelling of the mouth and throat, dizziness, fainting, trouble breathing, itching and hives. Anaphylaxis symptoms could arise 24 hours or more after using Xolair, and can occur after any dose, even if the patient had no reaction with the first dose. Genentech must also provide a Xolair medication guide for patients.
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