Product Liability

FDA evaluating adverse events associated with Xolair asthma meds

The Food and Drug Administration (FDA) has announced it is evaluating interim safety findings from an ongoing study of the asthma treatment Xolair (omalizumab), which suggest those who use Xolair experience a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events compared to those not treated with the drug.

Xolair is approved for use by adults and adolescents (12 years of age and older) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.

The interim data, submitted by the manufacturer of Xolair, is titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS). The FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time. Until the study’s data is completed and evaluated, patients and health care providers should be aware of the possible risks with taking the medication.

The safety communication is in keeping with the FDA’s commitment to inform the public about ongoing safety reviews of drugs. The FDA will communicate any new findings when its analysis of the interim safety data is complete. The EXCELS study is ongoing and results are not expected until 2012.

Patients are encouraged to report side effects from the use of Xolair to the FDA’s MedWatch Adverse Event Reporting Program.