FDA is reviewing possible heart risks with asthma drug Xolair (omalizumab)

What is Xolair (omalizumab)?

Omalizumab (Xolair) is a monoclonal IgG antibody that selectively binds to human immunoglobulin E (IgE) used mainly in asthma to reduce allergic hypersensitivity. Omalizumab binds to Cε3 region of IgE. Its main drawbacks have been anaphylaxis risk in 1 to 2 patients per 1,000 and cost ($10,000 to $30,000 a year). The drug is used by 30,000 to 35,000 patients, representing less than one half of 1 percent of the eligible patient population.

What happened?

The U.S. Food and Drug Administration is conducting a safety review of Xolair (omalizumab), a drug used to treat 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.

The FDA has not made any conclusions about these data yet. Genentech spokeswoman Tara Cooper also said limitations in the existing data "preclude a definitive association with Xolair use.

The FDA says results are from observational study, not a randomized trial and is not advising asthma patients who use Xolair to stop.

What to do?

Dr. Tom Casale, the executive vice president of the American Academy of Allergy, Asthma & Immunology (and chairman of the department I work at), said in a CNN interview he "will recommend that his patients who are on the drug remain on it. These are the patients that are more likely to have (emergency room) visits, hospitalizations and more problems with their asthma." Still, he said, he would like to see the data that the FDA regulators have seen.

FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair. FDA.
U.S. reviewing possible heart risks with asthma drug. Reuters.
FDA scrutinizing safety of asthma drug Xolair. CNN.
Image source: Wikipedia, public domain.

When to Use Xolair (Omalizumab) in Asthma?
Use of omalizumab (Xolair) anti-IgE therapy beyond asthma
Anaphylactic Reaction to Omalizumab (Xolair) in a Patient with Severe Asthma
Is Xolair cost-effective in severe asthma?
Does omalizumab (Xolair) cause bleeding or thrombocytopenia?
Joint Task Force Report on Omalizumab-associated Anaphylaxis

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