Tuesday, October 21, 2014

asthma drug, Xolair - Omalizumab May Elevate Risk of Cardiovascular, Cerebrovascular Adverse Events

Be careful out there.
http://www.docguide.com/omalizumab-may-elevate-risk-cardiovascular-cerebrovascular-adverse-events
A review of safety studies by the US Food and Drug Administration (FDA) suggests a slightly increased risk of cardiovascular and cerebrovascular adverse events among patients being treated with the asthma drug omalizumab (Xolair) than in those who were not treated with the drugs.
As a result, the 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, the 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.
Information for healthcare professionals:
• The FDA has added information about the findings of a slightly elevated risk of cardiovascular and cerebrovascular serious adverse events in omalizumab -treated patients to the Adverse Reactions section of the omalizumab label. The FDA has also added information about uncertain findings regarding a potential risk of cancer to the Warnings and Precautions section of the drug label.
• Periodically reassess the need for continued therapy with omalizumab based on the patient’s disease severity and level of asthma control.
• The appropriate duration of therapy for chronic idiopathic urticaria has not been evaluated. Periodically reassess the need for continued omalizumab therapy.
• Instruct patients receiving omalizumab not to decrease the dose or stop taking the drug or any other asthma medicines unless you instruct them to do otherwise.
• Provide and instruct patients to read the omalizumab patient Medication Guide before starting treatment and before starting each new prescription.
• Report adverse events involving omalizumab to the FDA MedWatch program.
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: www.fda.gov/MedWatch/report.htm

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