FDA looks into Xolair side effects
TAKE IT TO HEART- A link between an asthma drug and adverse heart and cerebrovascular effects is being investigated by the United States drug regulator.
The US Food and Drug Administration is looking into findings of a study which suggested that Xolair (omalizumab) had caused an increased number cardiovascular and cerebrovascular adverse events.
Approved in Australia but not available on the PBS, Xolair is an S4 drug prescribed for adult and adolescent patients with moderate to severe allergic asthma who do not respond to inhaled corticosteroids.
The ongoing study observed about 5,000 Xolair users over a five-year period, comparing them to 2,500 patients not treated with the drug.
"The interim data suggests 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," a statement from the FDA said.
The regulator did not recommend any changes to Xolair prescribing information and did not advise patients to stop taking the drug.