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Asthma Drug Could Cause Allergic Reaction, FDA Says
WASHINGTON – The FDA warned that Genentech Inc.’s asthma drug Xolair can cause a life-threatening allergic reaction and asked the company to put a black box warning label on the drug. The agency said clinical studies suggested the rate of the reaction, known as anaphylaxis, was about 1 in 1,000 patients and typically occurred within 2 hours after receiving the first dose.
Now, the FDA says it has continued to receive reports of anaphylaxis out side the 2-hour time frame as well as reports of incidents with any dose of the drug, even if a patient didn’t have a reaction to an earlier dose. About 40,000 patients in the U.S. have received Xolair since it was approved in 2003 to treat adults and adolescents.
A joint statement from Genentech, of South San Francisco, California, and Switzerland’s Novartis AG, which co-markets the drug in the U.S., said the companies were “in discussion with the FDA to update Xolair prescribing information to reflect additional information on the potential risk for anaphylaxis.
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