Ashley Milano  |  November 25, 2014

Category: Legal News

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xolair side effects lawsuit

Following a recent review of data from a five-year study conducted by Genentech, the U.S. Food and Drug Administration (FDA) determined in September that new Xolair warnings are needed about the potential risk of heart problems, brain problems and possibly even a risk of cancer from the asthma medication.

Xolair (omalizumab) is a Genentech drug approved by the FDA in 2003 for the treatment of moderate to severe asthma. Xolair is an injectable drug administered by a doctor every two-four weeks for asthma patients over the age of 12, whose asthma symptoms are not well controlled by inhaled corticosteroid medications.

Xolair prevents asthma attacks by blocking human immunoglobin E (IgE), which is an antibody that is commonly involved in allergic reactions. IgE may play an important role in the body’s recognition of cancer cells, which suggests that blocking IgE could be associated with cancer risks. According to the FDA’s safety alert, Xolair can narrow blood vessels that supply blood to the brain and heart, potentially causing heart attacks and strokes.

These conclusions were based on an evaluation of a safety study involving 5,000 patients with asthma, compared to 2,500 patients who did not take Xolair. The study, “Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma” (EXCELS), suggested that Xolair may also increase the risk of deadly blood vessel problems in the heart and brain.

Xolair FDA Black Box Warning

Following a review of data from the EXCELS study, the FDA determined that the prior Xolair warnings were inadequate and released an alert on the increased risks of Xolair.

New information was also added to Xolair’s labeling about the risk of Xolair heart problems and issues with blood vessels problems. In addition, since the long-term study could not rule out concerns raised in prior clinical trials about a link between Xolair and cancer, information was also to the drug label about higher rates of various cancers among users.

Xolair’s packaging contains what is known as a “black box warning,” which is the most severe warning from the FDA. Drugs with black box warnings can reasonably cause permanent or fatal injuries in patients. Among the side effects listed on Xolair’s black box labeling is the possibility of anaphylaxis, or severe allergic reaction. Other life-threatening side effects of Xolair may include:

  • Mini-strokes
  • Transient ischemic attacks
  • Heart attacks
  • Sudden, unexpected chest pain
  • High blood pressure in arteries of the lungs (pulmonary hypertension)
  • Blood clots in the lungs (pulmonary embolism)
  • Blood clots in veins (venous thrombosis)

The potential for Xolair product liability lawsuits are being evaluated for former users of the asthma medication and questions have been raised about whether clinical use of the medication is appropriate. This has led some to speculate that a Xolair recall may be necessary.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Xolair attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Xolair class action lawsuit is best for you. [In general, Xolair lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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Join a Free Xolair Class Action Lawsuit Investigation

If you or a loved one used Xolair (omalizumab) and experienced a heart attack, stroke, pulmonary hypertension, pulmonary embolism, blood clots, cancer or other serious side effect, you may have a legal claim. Submit your information now for a free case evaluation.

A Xolair attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

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