On July 16, 2009, the FDA announced that it has begun a safety review of Genentech’s asthma drug Xolair (omalizumab) after reports of an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The Xolair safety review was prompted by interim results from an ongoing study of 5,000 patients with allergic asthma, in which half of the patients took Xolair and half did not. The early results showed a “disproportionate increase” in certain cardiovascular and cerebrovascular problems in patients treated with Xolair.
Xolair has been available since 2003 and is given by injection to patients who are at least 12 years old and have moderate-to-severe persistent allergic asthma that does not respond to inhaled corticosteroids.
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 at this time. Rather, the FDA is simply attempting to make healthcare providers and patients aware of the risks and benefits of the drug, both those contained in the prescribing information and those seen in this clinical study. Currently, there is a black boxed warning about the risk of anaphylaxis.
If you have any questions related to this information, please contact us at Pogust Braslow & Millrood. Additionally, as with any medication, side-effects related to these drugs should be reported to the FDA.