In a Safety Alert issued posted on September 26th, the agency stated that “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) than in those who were not treated with Xolair”.
In light of these findings, the warning label will be updated to reflect these risks.
The review showed that Xolair was associated with a slightly elevated rate of cardiovascular problems, including mini-strokes referred to as transient ischemic attacks (TIAs), heart attacks, sudden unexpected chest pain, high blood pressure in the arteries of the lungs (pulmonary hypertension) and blood clots in the lungs and veins.
Additionally, the review did not show a significant difference in the rates of cancer between Xolair users and non-users. However, the FDA says that the risk of cancer cannot be ruled out because of the limitations of a 5-year study; therefore, this information has been added to the drug label as well.
Xolair is an injectable asthma medication used in patients
Xolair is an injectable asthma medication used in patients at 12 years old with moderate to severe persistent asthma that cannot be treated with corticosteroids. Patients should not stop taking medications on their own, and speak with their physician about any concerns.
In 2009, the FDA announced that it would be conducting an ongoing safety review of Xolair to determine its safety profile.
The 5-year study involved 5000 patients treated with Xolair and 2,500 patients that were not treated with Xolair.
At the time, the agency said that interim data submitted by manufacturer Genentech showed “a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug.”