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In previous animal studies involving Xolair and pregnancy, the medicine did not appear to cause any problems. Therefore, the FDA has classified Xolair as a pregnancy Category B medication, meaning it is probably safe for women who are pregnant. A pregnant woman may take Xolair if her healthcare provider decides that its benefits outweigh the possible risks to her unborn child.
Is Xolair Safe During Pregnancy?Xolair® (omalizumab) is probably safe for women who are pregnant. In previous animal studies involving Xolair and pregnancy, the drug did not cause any problems.
Xolair and Pregnancy Category BThe U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies.
However, it is important to note that animals do not always respond to medicines in the same way that humans do, and the full risks of using Xolair during pregnancy are not known. Therefore, Xolair should be given to a pregnant woman only if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.