FDA Checking Heart Risk of Xolair
Early Study Data Suggest Link Between Asthma Drug and Heart Disorders
July 16, 2009 -- The FDA is reviewing a possible link between the asthma drug Xolair and an increased risk of heart and cerebrovascular disorders.
Since the FDA investigation is still under way, the agency is not telling doctors to stop prescribing Xolair and is not recommending any changes to the prescribing information for Xolair.
The FDA is looking at interim results of an ongoing study of 5,000 patients with allergic asthma who take Xolair and 2,500 asthmatics who do not take Xolair.
Interim data, submitted by Xolair's manufacturer, Genentech, shows a disproportionate increase in heart and cerebrovascular events in patients treated with Xolair, compared to those who were not given the medication.
Xolair is given by injection to patients who are at least 12 years old and have moderate-to-severe persistent allergic asthma that doesn't respond to inhaled corticosteroids.
"FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time," an FDA news release reads. "Until the evaluation of the EXCELS study is completed, 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 cardiovascular and cerebrovascular adverse events."
The FDA asks health care professionals and patients to report side effects from the use of Xolair to the FDA's MedWatch Adverse Effects Reporting program. To do so, use any of the following contact information:
- Phone: 800-332-1088
- Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
- Mail: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787