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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 (800) 986-8999.
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.
Criteria for enrollment include:
- A report of pregnancy from a
patient or healthcare provider (US residents only)
- Exposure to SINGULAIR during
pregnancy (anytime after the woman's last menstrual period)
- Name of a healthcare provider
(to confirm diagnoses and to obtain outcome information)
- Name of the patient or, if you
wish to keep the report confidential, patient initials and 1
other patient identifier, such as date of birth or chart number,
to allow for follow-up at expected date of delivery
Information from the Registry is used to respond
to inquiries from healthcare providers who call to request information
on the use of a product during pregnancy. Data may be published
or used to update the pregnancy section of the product label, as
appropriate. Dissemination of data collected in the Registry is
done without compromising individual patient confidentiality. Information
from the Registry is shared, as required, with regulatory authorities
(eg, the FDA).
Annual Reports
Reports of the aggregate data in the Registry are
updated annually and are available to healthcare providers in the
United States upon request. (In countries outside the United States, information
is available through the local Merck subsidiary). To request a report,
call the toll-free number below or download and complete the attached
Annual Report Request Form and fax it to the Registry. Please include
your fax number. A report will be sent to you within 3 business
days.
Merck does not recommend the use of its products
in any manner other than as described in the product circular. Please
review the full
Prescribing Information before prescribing SINGULAIR.
Pregnancy Registry for SINGULAIR
1-800-986-8999
(FAX) 215-993-1220
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