The FDA warned that the asthma drug omalizumab slightly increases the risk of cardiovascular and cerebrovascular events in patients treated with the medicine.
The agency reviewed studies on the safety of omalizumab (Xolair, Roche, Genetech/Novartis), an injectable therapy for patients 12 years old and older who have moderate to severe persistent allergic asthma not controlled by inhaled corticosteroids. The assessment included cardiovascular, cerebrovascular and cancer risks.
The FDA reported a heightened risk of serious cardiovascular and cerebrovascular events but not cancer with treatment. It added that the five-year follow-up limited its ability to determine long-term effects. It called for an added warning to omalizumab’s labeling.