Singulair and Pregnancy

In animal studies on Singulair and pregnancy, the drug did not appear to cause problems in either the pregnant rats or their offspring. As a result, the FDA has classified it as a pregnancy Category B medication. Although the full risks are unknown, if you are taking Singulair and pregnancy occurs, your healthcare provider may have you continue taking it if the benefits outweigh the risks.

 

Is Singulair Safe During Pregnancy? -- An Overview

Singulair® (montelukast sodium) is generally safe for women who are pregnant. In animal studies that looked at the effects of the drug on pregnancy, Singulair did not cause any problems.
 

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.
 

Singulair and Pregnancy: Final Thoughts

If you are taking Singulair and pregnancy occurs, or if you are thinking of becoming pregnant while taking the drug, let your healthcare provider know. He or she will consider both the benefits and risks of using the drug during pregnancy before making a recommendation in your particular situation.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;