FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair

The U.S. Food and Drug Administration announced today that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma.

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. 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.

An FDA Early Communication is available online.

The Early Communication is in keeping with the FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Once its review is completed, the FDA will communicate its findings and any resulting recommendations to the public. Until the evaluation is completed, health care professionals and patients should be aware that the agency is reviewing data that may suggest a risk of adverse events. The FDA is not advising a change in prescribing or use of the drug.

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