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In studies involving Accolate, the medication did not cause any problems when it was given to pregnant rats. However, it is important to keep in mind that animals don't always respond to medicines in the same way that humans do and that the full risks of using Accolate during pregnancy are not known. Talk with your healthcare provider about the benefits and risks in your particular situation.
Accolate® (zafirlukast) is generally safe for women who are pregnant. In previous animal studies that looked at the effects of Accolate during pregnancy, the drug did not cause any problems.
The 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 cause harm to the fetus in animal studies.
In previous animal studies involving Accolate and pregnancy, large doses of Accolate were given to pregnant rats. No problems were seen with either the pregnant rats or the fetal rats.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Also, the full risks of using Accolate during pregnancy are not known. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn child.
If you are pregnant or thinking of becoming pregnant while taking Accolate for asthma, let your healthcare provider know. He or she will consider both the benefits and risks of using Accolate during pregnancy before making a recommendation for your particular situation.