After reviewing safety studies, the Food and Drug Administration (FDA) has found a slightly increased risk of problems involving blood vessels supplying the heart and brain in patients taking Xolair (omalizumab). The FDA has added information about these potential risks to the drug label.
According to the FDA Drug Safety Announcement, the heart and brain blood vessel problems included mini-strokes known as transient ischemic attacks or TIAs; heart attacks; sudden, unexpected chest pain; high blood pressure in the arteries of the lungs called pulmonary hypertension; and blood clots in the lungs and veins.
Xolair is an injectable asthma medicine for patients 12 years of age and older with moderate to severe persistent allergic asthma whose asthma symptoms are not controlled by asthma inhaled corticosteroid asthma medications, the FDA explains. Omalizumab works by helping to block IgE (immunoglobulin E), a substance that may cause reactions in the body that can lead to asthma attacks and symptoms, according to the Mayo Clinic. Xolair has helped reduce asthma attacks in patients who have elevated levels of IgE in their blood.
The FDA review found no difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated with Xolair. But due to limitations in the 5-year study, the 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.
The FDA advises patients taking Xolair to continue to take the medication as prescribed and discuss their questions or concerns with a health care professional. The agency encourages health care professionals and patients to report adverse events or side effects related to the use of Xolair to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.htm.