Are there any risks associated with taking singulair during pregnancy?

Answer 1

No one knows for sure how Singulair will effect your unborn baby. They aren't allowed to give pregnant women drugs and see how the babies turn out, because that wouldn't be ethical.

When they studied use of Singulair in animals, no birth defects were observed in rats at oral doses up to 100 times the recommended Singulair dose. The drug does, however, cross the placenta (and enter the fetus' bloodstream) following oral dosing in rats and rabbits.

**There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, SINGULAIR should be used during pregnancy ONLY IF CLEARLY NEEDED.**

Merck & Co., Inc. maintains a registry to monitor the pregnancy outcomes of women exposed to SINGULAIR while pregnant. Healthcare providers are encouraged to report any prenatal exposure to SINGULAIR by calling the Pregnancy Registry at [phone].

Good luck.

Answer 2

The Pregnancy Registry for SINGULAIR receives voluntary reports from healthcare providers or from women/family members/friends about women who inadvertently (before knowing they were pregnant) or purposefully (knowingly took the drug to control their asthma) used SINGULAIR during pregnancy. The women are enrolled and their pregnancies are followed. Outcomes are obtained from participating clinicians.

SINGULAIR has been assigned FDA Pregnancy Category B. No teratogenicity was observed in rats at oral doses up to 400 mg/kg/day (estimated exposure was approximately 100 times the AUC for adults at the maximum recommended daily oral dose) and in rabbits at oral doses up to 300 mg/kg/day (estimated exposure was approximately 110 times the AUC for adults at the maximum recommended daily oral dose). Montelukast crosses the placenta following oral dosing in rats and rabbits. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, SINGULAIR should be used during pregnancy only if clearly needed.

During worldwide marketing experience, congenital limb defects have been rarely reported in the offspring of women being treated with SINGULAIR during pregnancy. Most of these women were also taking other asthma medications during their pregnancy. A causal relationship between these events and SINGULAIR has not been established.

Merck & Co., Inc. maintains a registry to monitor the pregnancy outcomes of women exposed to SINGULAIR while pregnant. Healthcare providers are encouraged to report any prenatal exposure to SINGULAIR by calling the Pregnancy Registry at [phone].

Enrollment:

Healthcare providers are encouraged to report cases of prenatal exposure as early in pregnancy as possible to facilitate the collection of prospective, unbiased information. Enroll your patient by completing the simple 1-page enrollment form available below. You will be asked to complete a second 1-page Outcome of Pregnancy form at the end of the pregnancy. We provide you with a 1-page patient consent form that explains the Pregnancy Registry to your patient. We encourage you to review it with your patient and have her sign it before the end of her pregnancy. All forms can be faxed (or mailed) to the Pregnancy Registry.

Answer 3

Call and ask your pharmacist. While doctors know what drugs should be given for what conditions, pharmacists know the drugs inside and out, who should and should not take them, what other medications they interract with, etc. Any time I'm given a prescription for a drug I'm unfamiliar with, I always ask my pharmacist. (This is a good practice to have, pregnant or not!)