The FDA is evaluating interim safety findings from Genentech, Inc. in an ongoing study of XOLAIR problems. XOLAIR (omalizumab) is an injected drug for asthma related allergies. The interim results of this study, which is being conducted by the drug’s manufacturer, suggests an increased number of cardiovascular (heart attack) and cerebrovascular (stroke) adverse events in a group of patients using Xolair compared to a group of patients not given the drug (control group).
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 results this 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.
The FDA originally approved XOLAIR in 2003 but announced in February of 2007 that it was requesting a stronger warning for XOLAIR because it may cause anaphylaxis, a reaction that may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat.
“It is important for persons who have used or are using XOLAIR to be aware of the side effects and hazards,” stated James Onder of Onder, Shelton, O’Leary & Peterson, LLC. The firm’s XOLAIR safety information web site contains information regarding XOLAIR side effects and the rights those suffering from them may have. The attorneys of The Onder Law Firm will review will provide free case review to persons having experienced side effects or medical problems after taking XOLAIR. The Onder Law Firm provides experienced legal representation without fee unless it collects for its clients.
About The Law Firm
Onder, Shelton, O’Leary & Peterson, LLC is a personal injury 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 in pharmaceutical litigation such as Vioxx, Digitek, Ethex and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation. For more information, visit www.onderlaw.com or call 1-877-ONDER-LAW.
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