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Xolair (omalizumab) is a drug used to treat moderate to severe cases of asthma and is administered by injection to individuals over the age of 12 who suffer from asthma caused by year-round allergens. Xolair is an antibody that works by reducing the number of allergic asthma attacks in people who are still suffering from asthmatic symptoms even though they are using a separate inhaled steroid.

Side Effects of Xolair

Xolair has been found to cause a severe allergic reaction called anaphylaxis in some people. Anaphylaxis is a potentially life-threatening allergic reaction that may develop suddenly after an individual has been treated with Xolair.

Some symptoms of anaphylaxis may include:

  • Difficulty breathing
  • Hypotension (low blood pressure)
  • Vomiting or diarrhea
  • Hives or other skin rashes
  • Swelling of the tongue, lips and throat
  • Dizziness or lightheadedness

In Feb. 2007 the FDA issued a “black box” warning for Xolair after receiving 48 reports of anaphylaxis associated with the drug. The Food and Drug Administration warns that individuals injected with Xolair have an increased risk of developing anaphylaxis within 24 hours. Patients who have received previous injections of Xolair are also at risk.

Other side effects of Xolair could include viral infections, upper respiratory tract infections, sinusitis and malignancy. If you have experienced symptoms of anaphylaxis or other symptoms associated with Xolair, it’s important that you see your doctor immediately.

2009 FDA Safety Review of Xolair

In July of 2009 the Food and Drug Administration began a safety review of Xolair after receiving reports of increased risk of heart attack, heart failure, abnormal heart rhythm and stroke associated with the drug. Results from the Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) trial found that Xolair increases the risk of heart problems. The FDA would like both doctors and patients to be aware of the potential risk of heart attack or stroke when taking Xolair.

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