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Xolair Warning

The makers of the asthma drug Xolair were ordered in February 2007 to add a “black box” warning to the label, alerting doctors and patients of the serious side effects associated with its use, including anaphylaxis—a life-threatening allergic reaction. Xolair (generically sold as omalizumab) was approved by the U.S. Food and Drug Administration in 2003 for the management of asthma in patients 12 years and older who do not respond to inhaled drugs. Since it's FDA approval, Xolair, which is administered through an injection, has been prescribed to almost 40,000 Americans, putting them at risk of experiencing serious adverse events.

If you or someone you love has suffered harm as a result of taking Xolair, you may be eligible to take legal action against Genentech, the drug manufacturer, to seek compensation for your economic and non-economic damages. To learn more about your legal rights, please contact us today to speak with an effective product liability attorney near you. An experienced attorney can evaluate your case at no charge and determine the best course of action.

Revised Xolair Warning Label

The call for the stronger Xolair warning was prompted by reports of 48 cases of anaphylaxis, which causes difficulty breathing, drop in blood pressure, hives, swelling in the tongue and throat, and narrowing of air passages. While the drug already carried a label citing other Xolair side effects such as malignancies, upper respiratory infection, viral infection, and more, the new revised warning added the following:

  • Raised risk of developing anaphylaxis (occurred in 0.1 percent of patients)
  • Patients may experience a delayed allergic reaction (two to 24 hours after injection)
  • Medical professionals should monitor patients for several hours after injection and be prepared to manage potentially fatal reactions

The FDA also urged Genentech to create a patient medication guide and encouraged users to learn the signs of anaphylaxis and carry an Epi-Pen (epinephrine auto-injector) to treat themselves in case of allergic reaction

Legal Help

If you or a loved one has suffered anaphylaxis or other serious side effect of Xolair, it is important to consult with a skilled product liability attorney to find out if you are entitled to compensation for your losses. Please contact us today to get in touch with a qualified attorney near you who can evaluate your case FREE of charge and help protect your legal rights and interests.

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