Singulair and Pregnancy Category B
The U.S. Food and Drug Administration (FDA) uses a 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 that do not appear to cause harm to the fetus in animal studies.
When large doses of Singulair were given to pregnant rats, no problems were seen with 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, and the full risks of using the drug when pregnant are not known. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the mother outweigh any possible risks to the unborn child.
