Xolair Being Investigated for Possible Link to Heart Problems, StrokesJul 17, 2009 | Parker Waichman LLP Xolair is undergoing a Food & Drug Administration (FDA) safety review because of a possible link to heart problems and strokes. However, despite the concerns, the FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking the drug at this time.
Xolair is approved for use by adults and adolescents (12 years of age and above) 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 current FDA safety review was prompted by interim safety findings from an ongoing study of Xolair that suggests an increased number of heart problems and strokes in a group of patients using Xolair compared to a group of patients not given the drug.
The ongoing study, called Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an observational study of approximately 5000 Xolair treated patients and a control group of approximately 2500 non-Xolair treated patients. The primary objective of the EXCELS study is to assess the long-term safety profile of Xolair in patients followed for 5 years. Study patients are 12 years of age and older with moderate to severe persistent asthma and who have a positive skin test or blood test for an aeroallergen.
The FDA said that interim data from EXCELS 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.
Until the evaluation of the EXCELS study is completed, the FDA says healthcare providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of heart problems and strokes.
The FDA has not made any conclusions regarding EXCELS. The agency said it is working with Genentech, the manufacturer of Xolair, to obtain further information and will continue to review the strengths and limitations of these interim results. For example, since EXCELS is an observational study, there could be differences in underlying risk factors for heart problems and strokes between the two study groups. The FDA said it will communicate any new findings when its analysis of the interim safety data is complete. The EXCELS study is ongoing and final results are not expected until 2012.