FDA: Ongoing Omalizumab Study Shows Increased Number of Cardiovascular Events

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Published at: www.docguide.com

Omalizumab possibly associated with cardiovascular side effects

July 23, 2009

Analysis by: GLG Expert Contributor

The interim analysis of the large scale study comprising 5000 patients treated by omalizumab and 2500 controls suggest an increased frequency of cardiovascular and cerebrovascular complication in the active treatment group.The centers administering omalizumab to patients with asthma should be aware of this possibility and actively look for any signs of such complications. This new information should be apparently included into the decision algorithm for omalizumab indication in risk persons.

Cardiovascular events

July 20, 2009

Analysis by: GLG Expert Contributor

Increased events likely from increased leukotrienes would be very hazardous as many smokers have lung and hear disease limiting its use in these situations.

Dr. Richard Frank Lavi, MD

July 19, 2009

Analysis by: GLG Expert Contributor

"The interim data, submitted by the manufacturer of Xolair , suggest 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," according to the FDA's announcement.