FDA MedWatch: Xolair (omalizumab) New Reports of Serious and Life-Threatening Allergic Reactions (anaphylaxis)

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

ROCKVILLE, Md., Feb. 21, 2007--FDA notified asthmatic patients and healthcare professionals of new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair. Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection. However, these new 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. 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. FDA has requested Genentech add a boxed warning to the product label and to revise the label and provide a Medication Guide for patients.

Read  more information below. The label is attached.

FDA ALERT [2/2007]: FDA has received new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair (omalizumab).  Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection.  However, these new 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 (see “Information for Patients” below).

Xolair is approved to treat adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.  The Xolair label includes warnings about the chance of anaphylaxis after treatment with Xolair. 

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but it has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

Call 1-800-FDA-1088 (1-800-332-1088)

Posted: February 2007


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