Intermin data from a study submitted to the FDA by Genentech, makers of the asthma drug Xolair (omalizumab) “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“, according to an FDA statement.
The FDA statement does not provide recommendations in regard to changes in prescriptions or prescribing information for Xolair, and is NOT advising asthma patients taking Xolair to stop taking the drug at this time. Until they have completed the evaluation of the EXCELS study, FDA is advising patients and healthcare providers to “be aware of the risks and benefits described in prescribing information, as well as the new information from ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events.”
The FDA is asking doctors who prescribe Xolair and the patients who take it to report side effects from the use of omalizumab (the active ingredient in Xolair) to the FDA’s MedWatch Adverse Event Reporting program: 1-800-332-1088
Use postage-paid FDA Form 3500
MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787