FDA Probing Asthma Drug Xolair for Heart Risk

The FDA is probing a possible connection between the asthma drug Xolair and an increased risk of cardiac and cerebrovascular problems. The probe comes as a result of a study submitted to the FDA by Xolair’s manufacturer Genentech that found a disproportionate increase in heart and cerebrovascular events in patients who have taken Xolair.
Xolair is an injectable drug given to patients 12 years or older that present moderate to severe persistent allergic asthma that doesn’t respond to inhalation of corticosteroids.
In its news release, the FDA stated, “”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 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