Xolair is an injectable asthma medication approved for use in patients 12-years-old and older who suffer from:

  • Moderate to severe persistent allergic asthma that is not controlled by asthma medicines called inhaled corticosteroids.
  • Chronic idiopathic urticaria (chronic hives without a known cause) not controlled by H1 antihistamine treatment.

Xolair has been on the market since 2003, and is jointly marketed by Roche (a subsidiary of Genentech) and Novartis AG.

Xolair is administered by a healthcare provider in 1 or more injections under the skin, once every two-to-four weeks.

Possible Xolair Side Effects

xolair heart attackThe most common Xolair side effects reported in asthma patients include pain in the arms and legs, dizziness, tiredness, skin rash, bone fractures, and ear pain. Patients who are treated with Xolair for chronic hives may experience nausea, headaches, swelling of the inside of the nose, throat or sinuses, cough, joint pain, and upper respiratory infection.

The Xolair label also bears a “black box” warning about the potential for anaphylaxis, a life-threatening allergic reaction that can occur in patients immediately after an injection, or within days of treatment. Symptoms to be aware of include:

  • Wheezing, shortness of breath, cough, chest tightness, or trouble breathing
  • Low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety
  • Flushing, itching, hives, or feeling warm
  • Swelling of the throat or tongue, throat tightness, hoarseness, or trouble swallowing

Patients who are treated with Xolair may face a higher risk for certain types of cancer, and they may be more likely to acquire certain parasitic infections.

FDA Xolair Safety Review

In 2009, the U.S. Food & Drug Administration (FDA) announced it was reviewing the safety of Xolair after interim results from a five-year study conducted by its manufacturer indicated that some patients treated with the medication may be more likely to experience certain cardiovascular and cerebrovascular side effect. The FDA announced the conclusion of that review in September 2014, and ordered the drug’s manufacturer to add new information to the Xolair label about the potential for the following adverse reactions:

  • Mini-strokes (also known as transient ischemic attacks or TIAs)
  • Heart attacks
  • Pulmonary hypertension (high blood pressure in the arteries of the lungs)
  • Blood clots in the lungs and veins

According to the agency, its review of the five-year study, as well as 25 other studies comparing Xolair to a placebo, suggested a strong safety signal for these events. But limitations in the research meant that the FDA was “unable to definitively confirm or determine the exact increased level of these risks with Xolair.”

Xolair Lawsuit Reviews

Individuals who experienced a cardiovascular or cerebrovascular event included in the FDA’s 2014 announcement may be able to file a Xolair lawsuit seeking compensation or their physical injuries, as well as financial and emotional damages. Those most eligible to pursue such a claim include younger Xolair users, as young people rarely experience heart attacks, mini-strokes or similar complications under normal circumstances. If you would like to explore your legal rights, please contact our office today by calling 888-994-5118.

  1. Genentech (March 21, 2014) Xolair (omalizumab) Full Prescribing Information http://www.gene.com/patients/medicines/xolair
  2. U.S. Food & Drug Administration (September 26, 2014) FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events. http://www.fda.gov/Drugs/DrugSafety/ucm414911.htm
Last Modified: December 8, 2015

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