The Food and Drug Administration (FDA) is warning about a slightly increased risk of cardiovascular and cerebrovascular events among patients being treated with Xolair (omalizumab; Genentech and Novartis) for asthma compared to those not treated with Xolair.

Xolair is an IgE blocker currently approved for chronic idiopathic urticaria in symptomatic patients despite H1-antihistamine treatment, and for moderate to severe persistent asthma in patients with a (+) skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled by inhaled corticosteroids.

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A review of safety studies found higher rates of transient ischemic attacks (TIAs); heart attacks; sudden, unexpected chest pain; pulmonary hypertension; and blood clots in the lungs and veins. Further review found no difference in the rate of cancer between patients taking Xolair and those not taking Xolair. However, the FDA could not rule out a potential cancer risk due to limitations in the 5-year study. Information about these potential risks has been incorporated into the drug label.

The following recommendations have been made by the FDA for healthcare professionals:

  • Periodically reassess the need for continued therapy with Xolair based on the patient’s disease severity and level of asthma control.
  • The appropriate duration of therapy for chronic idiopathic urticaria has not been evaluated. Periodically reassess the need for continued Xolair therapy.
  • Instruct patients receiving Xolair not to decrease the dose or stop taking the drug or any other asthma medicines unless you instruct them to do otherwise.
  • Provide and instruct patients to read the Xolair patient Medication Guide before starting treatment and before starting each new prescription.

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