FDA Xolair Warning

ATTENTION!
XOLAIR Allergic Asthma
Medication Users:
FDA Reviewing Preliminary XOLAIR Safety Information

XOLAIR Safety Information
Free XOLAIR Lawsuit Review

Problems with XOLAIR Have Been Linked to Heart Attack and Stroke
You or a loved one may be entitled to financial compensation if injury or death occurred while taking these medicines.

The FDA is evaluating interim safety findings from an ongoing study of XOLAIR (omalizumab) that suggests an increased number of cardiovascular and cerebrovascular adverse events in a group of patients using Xolair compared to a group of patients not given the drug (control group). XOLAIR (omalizumab) is an injected drug for asthma related allergies. The FDA originally approved XOLAIR in 2003 but announced in February of 2007 that it was requesting a stronger warning because XOLAIR may cause anaphylaxis, a reaction that may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat.

The FDA went on to reference in their April 17, 2007 notice to consumers that:

On July 17, 2009 the FDA announced that it was reviewing preliminary safety information on XOLAIR, stating that:

Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke.

XOLAIR blood clot complications

The possible association has been identified based on interim results from an ongoing study of Xolair known as Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS). The study is being conducted by the manufacturer, San Francisco-based Genentech Inc. Results from the drug manufacturer's EXCELS study are not expected until 2012.

Although the FDA and the drug manufacturer have not recalled XOLAIR, the FDA wants consumers to be aware of increased risks from taking XOLAIR, specifically heart attack/heart disease and stroke.


Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair) - July 16, 2009

If you believe that you or a loved one has suffered hospitalization or death as a result of using XOLAIR, fill out our online form or call us toll free at 1-877-DRUG-101.

XOLAIR Side Effects

Onder, Shelton, O'Leary & Peterson, LLC is a law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. Onder, Shelton, O'Leary & Peterson has represented clients throughout the United States, and other firms throughout the nation often seek its experience and expertise on complex litigation. For more information, visit www.onderlaw.com or call 1-877-DRUG-101.

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XOLAIR Safety Information


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