On February 21, 2007, the FDA announced that it requested Genentech, Inc. add a boxed warning to the product label for Xolair (Generic: Omalizumab). The boxed warning emphasizes that Xolair, used to treat patients with asthma related to allergies, may cause anaphylaxis. Anaphylaxis may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat. In addition, FDA has asked Genentech to revise the Xolair label and provide a Medication Guide for patients to strengthen the existing warning for anaphylaxis.
The FDA approved Xolair in 2003 to treat adults and adolescents (12 years of age and older) with moderate to severe persistent asthma who have tested positive for a perennial aeroallergen (pollen, grass or dust) and whose symptoms are insufficiently controlled with inhaled steroids.
In clinical trials, Xolair diminished the rate of asthma exacerbations, which were defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of baseline inhaled corticosteroid dose.
The FDA received new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair (Generic: Omalizumab). Typically these reactions take place within two hours of receiving a Xolair subcutaneous injection.
These latest reports include patients who had delayed anaphylaxis
However, these latest reports include patients who had delayed anaphylaxis; with onset two to 24 hours or even longer after receiving Xolair treatment. Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the patient had no allergic reaction to the first dose.
The symptoms and signs of anaphylaxis in these reported patients include bronchospasm, hypotension, syncope, urticaria, and angioedema of the throat or tongue.
Based on reports from approximately 39,500 patients, anaphylaxis following Xolair treatment occurred in at least 0.1% of treated people. Health care professionals who administer Xolair should be prepared to manage life-threatening anaphylaxis and should observe their Xolair-treated patients for at least two hours after Xolair is given.
Patients under treatment with Xolair should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following Xolair treatment, and how to treat it when it occurs.