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FDA Investigating Safety of Asthma Drug Xolair
Date:7/16/2009

heir individual patients."

One asthma expert was surprised by the FDA's action.

"In my experience, in properly selected patients, [Xolair] has been a great benefit and clinical improvement can be dramatic, on a case-by-case basis," said Dr. Clifford Bassett, a fellow at the American Academy of Allergy, Asthma and Immunology, and medical director of Allergy and Asthma Care of New York.

"As far as the possible events associated as indicated by the FDA release, I am surprised as I have not observed or seen those type of problems to date," he said.

Two years ago, the FDA warned of a connection between Xolair and anaphylaxis.

Anaphylaxis is a sudden, potentially life-threatening allergic reaction that can include trouble breathing, tightness in the chest, dizziness, fainting, itching and hives, and swelling of the mouth and throat.

At that time, the FDA asked Genentech to update the existing label warning and to provide a Patient Medication Guide with a strengthened warning for anaphylaxis.

More information

For more on asthma, visit the U.S. National Library of Medicine.



SOURCES: Clifford Bassett, M.D., fellow, American Academy of Allergy, Asthma and Immunology, and medical director, Allergy and Asthma Care of New York, New York City; Tara Cooper, spokeswoman, Genentech; July 16, 2009, news release, U.S. Food and Drug Administration


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