Xolair Allergic Reaction Prompts FDA Proposal For Boxed Warning

Lee Coleman

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The FDA has announced that there have been continued reports of post-marketing experiences of life-threatening anaphylaxis with Xolair (omalizumab). In 2003 Xolair was approved to treat moderate to severe persistent asthma in adults and adolescents 12 years of age and above who were unable to control their asthma with inhaled steroids. The cases of anaphylaxis was approximately one in a thousand at that time. The FDA has requested Genentech, Inc. to add a boxed warning to the product label to emphasize it may cause anaphylaxis. The patient may experience the reaction at any time after any dose of Xolair even if there is no reaction to the first dose, and may be delayed even 24 hours after a given dose.
Anaphylaxis is a life-threatening condition that can lead to death in minutes in severe cases. Some symptoms include: respiratory distress, low blood pressure, fainting, unconsciousness, hives, flushed appearance, swelling of face, neck and throat, vomiting, itching, diarrhea, anxiety, and abdominal pain. Persons experiencing any of these should contact a medical professional immediately for medical attention.