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Enews Now
June 2018

Food and Drug Administration (FDA) Roundup

An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab). As a result, FDA has added information about these potential risks to the drug label.

Some previous clinical trials have shown slightly higher rates of various cancers in patients treated with Xolair compared with non-Xolair-treated patients. FDA review of a 5-year safety study found no difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated with Xolair. However, due to limitations in the study reviewed, FDA cannot rule out a potential risk of cancer with Xolair, so this information was added to the Warnings and Precautions section of the drug label.

Patients taking Xolair should continue to take the medication as prescribed and discuss any questions or concerns with their healthcare professionals.

Healthcare professionals should:

  • Review the information FDA has added to the Adverse Reactions section and the Warnings and Precautions section of the Xolair label.
  • 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.
  • Report adverse events involving Xolair to the FDA MedWatch program.

For more information about the FDA’s review of the 5-year safety study of Xolair, please refer to the Drug Safety Communication here.