FDA Warns About Asthma Drug, Xolair

Extreme Allergic Reactions Seen in Patients Using Injected Drug

Feb. 21, 2007 -- The FDA is calling for a "black box" label warning for the asthma drug Xolair, alerting users it can cause potentially life-threatening allergic reactions.

The FDA issued the alert after reviewing 48 cases of anaphylaxis -- life-threatening allergic reactions -- submitted to the agency from June 2003, when Xolair was approved, through December 2005.

These cases included symptoms of bronchospasm (narrowing of airways), difficulty breathing, drop in blood pressure, fainting, hives, and swelling of the throat or tongue.



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