Safety Alerts for Human Medical Products > Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events

Safety Alerts for Human Medical Products > Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events

U.S. Food and Drug Administration (FDA) Advisory

• September 26, 2014: Xolair (omalizumab): 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 Xolair (omalizumab) than in those who were not treated with Xolair. 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 Xolair and those who were not being treated with Xolair. However, due to limitations in the 5-year study, FDA cannot rule out a potential risk of cancer with Xolair, so this information was added to the Warnings and Precautions section of the drug label.

Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events

[Posted 09/26/2014]

AUDIENCE: Allergy and Immunology, Pharmacy, Health Professional

ISSUE: 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 Xolair (omalizumab) than in those who were not treated with Xolair. 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 Xolair and those who were not being treated with Xolair. However, due to limitations in the 5-year study, FDA cannot rule out a potential risk of cancer with Xolair, so this information was added to the Warnings and Precautions section of the drug label.

BACKGROUND: Xolair is an injectable medicine for patients 12 years of age and older with moderate to severe persistent allergic asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.

RECOMMENDATION: Patients taking Xolair should continue to take the medication as prescribed and discuss any questions or concerns with their health care 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 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[09/26/2014 - Drug Safety Communication - FDA]

[07/16/2009 - Early Communication - FDA]