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Protect Your Health

Food, Medical Product & Cosmetic Safety

Published as part of a U.S. Food and Drug Administration and WebMD partnership to protect and promote your health. The following article is under sole editorial control of FDA.

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FDA Safety Update: Asthma Medications

(continued)

Anaphylaxis and Xolair

Xolair (omalizumab) is approved for treating moderate to severe persistent asthma related to allergies in patients whose symptoms are not controlled with inhaled corticosteroids. In February 2007, FDA requested that Genentech add a boxed warning to the Xolair product label. The boxed warning emphasizes that Xolair may cause anaphylaxis, an allergic reaction that may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat.

Advice for patients …
It's important to know that patients may develop this reaction after any dose of Xolair, even if there was no reaction to the first dose. Also, anaphylaxis after administration of Xolair may be delayed up to 24 hours or more after the dose is given.

Patients who take Xolair should know the symptoms of anaphylaxis, and should also know how to initiate emergency self-treatment.

For more information about topics for your health, visit the FDA Consumer Information Center (www.fda.gov/consumer).

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