The asthma drug Xolair (omalizumab) for children and adults 12 years of age and older can cause problems with the heart and blood vessels supplying the brain, the Food and Drug Administration (FDA) announced after a review of safety studies. As a result, new warnings of an elevated risk of serious cardiovascular and cerebrovascular adverse events will be added to the drug’s label.
The review also investigated rates of cancer between patients using Xolar and found no difference compared to patients not being treated with Xolair. However, due to limitations in the five-year study, the agency cannot rule out the a potential risk of cancer with the drug, so this warning was also added to the drug’s label.
Xolair is an injectable medicine for patients with moderate to severe persistent allergic asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.
Patients currently taking Xolair are advised to continue taking the medication as prescribed and to contact their doctors with any questions or concerns. Medical professionals and patients are advised to report any side effects to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.