Xolair is an injectable prescription drug prescribed for patients with moderate to severe persistent asthma. Recently, an ongoing study of Xolair revealed that users of the drug may experience a disproportionate increase in heart disease, arrhythmias, heart failure and stroke. The study was conducted by the manufacturer of the drug, Genentech, and consisted of 5,000 participants who were taking the drug and 2,500 participants who were not. No statistical information has yet been released, but the Food and Drug Administration has indicated that they are conducting an independent evaluation of Xolair to determine its safety.
In 2007, the FDA required the manufacturer of Xolair to issue a black box warning on its label which outlined the risk of severe or even fatal anaphylactic reaction to the medication. The label also warned of increased risk of malignancy. However, the label made no mention of any risks associated with Xolair and heart attack or stroke.
Although the study seems to indicate a real risk of heart attack or stroke, the FDA is not recommending that patients stop taking the drug or that the drug be withdrawn from the market at this time. Health care providers and users should be aware of these risks and use this information to determine the risks and benefits to individual patients. If you want more information on this subject, contact Danielle Mason or Leigh Odell in our firm at 800-898-2034 or Danielle.Mason@beasleyallen.com or Leigh.Odell@beasleyallen.com.
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