Xolair is prescribed to treat moderate to severe asthma caused by allergies. Xolair is manufactured by Genentech and was approved by the FDA in 2003 for treatment of patients 12 years old and up.

In 2009, the FDA issued a statement warning healthcare professionals about serious side effects associated with this asthma drug. Studies have linked the use of Xolair to an increased risk of heart attack, stroke and other issues that could be fatal.

One study, Evaluating the Clinical Effectiveness of Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), compared patients who used Xolair for over five years to a control group. Of the 5,000 patients with asthma, the study showed a significant increase in cardiovascular events.

Xolair has also been linked to anaphylaxis and severe allergic reactions. This serious side effect has even been reported in patients who have not previously suffered from drug reactions. Anaphylaxis was also seen to occur after any dose, not just limited to the first dose of the drug. This side effect has also been seen to have delayed reactions, occurring even a day after being administered the drug. The delayed reaction was seen in approximately one out of every 1,000 patients.

The FDA added a black-box warning to Xolair in 2007 to warn about the risk of anaphylaxis.

Serious side effects may include:

  • Wheezing, tightness in your chest,rouble breathing
  • Hives or skin rash
  • Feeling anxious or light-headed, fainting
  • Warmth or tingling under your skin
  • Swelling of your face, lips, tongue, or throat
  • Less serious Xolair side effects may include:
  • Pain
  • Headache, tired feeling
  • Joint or muscle pain
  • Dizziness
  • Ear pain
  • Hair loss
  • Mild itching or skin rash
  • Sore throat or cold symptoms
  • Redness, bruising, warmth, burning, stinging, itching, pain, or swelling of your skin where the injection was given
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