FDA: Slightly elevated risk of cardiovascular, cerebrovascular issues with Xolair

September 29, 2014

An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug omalizumab (Xolair, Genentech) than in those who were not treated with omalizumab. As a result, FDA has added information about these potential risks to the drug label.

An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug omalizumab (Xolair, Genentech) than in those who were not treated with omalizumab. As a result, FDA has added information about these potential risks to the drug label.

The review found no difference in the rates of cancer between those patients being treated with omalizumab and those who were not being treated with omalizumab. However, due to limitations in the 5-year study, FDA cannot rule out a potential risk of cancer with omalizumab, so this information was added to the Warnings and Precautions section of the drug label.

“Omalizumab is one of those ‘niche’ drugs that is only utilized by pulmonologist on their asthma patients who are classified as having severe asthma,” according to FormularyWatch advisor James M. Wooten, PharmD, associate professor, department of medicine, University of Missouri-Kansas City School of Medicine. 

“These patients must also have elevated serum IgE levels,” Dr Wooten said. “Elevated serum IgE levels [IgE is an immune globulin] indicates a specific allergic component with the asthma. Omalizumab then binds IgE and reduces the number of asthma attacks.  Pulmonologists have told me that it is quite effective in the right patients. Although an increased number of heart attacks, strokes or transient ischemic attack [TIA] is is concerning, it appears that FDA is unsure what to do with the data since the study design was week. This data will be included in subsequent package inserts for the drug.

“Patients taking omalizumab do not inject themselves with the drug but rather, are required to go to the doctor’s office every few weeks for drug administration.  In this way, the doctor can be present for any possible reactions,” Dr Wooten continued.

Patients taking omalizumab should continue to take the medication as prescribed and discuss any questions or concerns with their healthcare professionals.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

·       Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

·       Download form or call (800) 332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to (800) FDA-0178