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Page: << Prev | 1 | 2 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.
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Mike Tringale, director of external affairs for the Asthma and Allergy Foundation of America, said that there was nothing in the FDA's statement that called for stopping the trial or adding a "black box" warning to the drug.
"The statement today was a usual and customary keeping [of] patients in the loop," he said.
"I am not overly concerned," Tringale said. "But it would be irresponsible not to keep an eye on the accumulating data. It's an opportunity for patients to discuss this with their doctor."
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.
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