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The Pregnancy Registry for MAXALT receives voluntary
reports from health care providers or from women/family members/friends
about women who inadvertently (prior to knowing they were pregnant)
or purposefully (knowingly took the drug to treat their migraine)
used MAXALT during pregnancy. The women are enrolled and their pregnancies
are followed. Outcomes are obtained from participating clinicians.
MAXALT has been assigned to FDA Pregnancy Category
C; therefore, MAXALT should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Migraine and Pregnancy Outcomes
Migraine and tension-type headache are primary headache
disorders that occur during pregnancy. Migraine sometimes occurs
for the first time with pregnancy. Migraine patients may improve
during pregnancy; however, migraine often recurs postpartum. Although
anti-migraine medications are used during pregnancy, there is insufficient
knowledge about their effects on the growing fetus.
A literature review revealed one published study
of rates of birth defects among migraineurs. Wainscot et al (1978)
conducted a study of 450 ever-pregnant female migraine patients
(subjects) and 136 ever-pregnant wives of male migraine patients
(controls) at the Princess Margaret Migraine Clinic in London between
1973 and 1974. Regardless of drug use history, infants of the migraineurs
had no increased risk of either major or minor abnormalities compared
with infants of the controls. The abnormality rates reported for
both migraineurs (3.35%) and controls (3.97%) were similar to national
averages.
Wainscot, G.,
Volans, G.N., Sullivan, F.M., Wilkinson, M. (1978) The outcome of
pregnancy in women suffering from migraine. Postgraduate Medical
Journal, 54:98-102.
Enrollment:
Health care 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 one-page enrollment
form available below. You will be asked to complete a second one-page
Outcome of Pregnancy form at the end of the pregnancy. We provide
you with a one-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 health care provider (U.S.
residents only)
- Exposure
to MAXALT during pregnancy (anytime after the woman's last menstrual
period)
- Name
of a health care 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 one other patient identifier, like 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 health care 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
(e.g., FDA).
Annual Reports
Reports of the aggregate data in the Registry are
updated annually and are available to health care providers in the
U.S. upon request. (In countries outside of the U.S., information
is available through the local Merck subsidiary). To request a report,
call the 800 number below or download and complete the attached
Annual Report Request Form and fax it to the Registry. Please include
your fax number and 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 MAXALT.
Pregnancy Registry for MAXALT
1-800-986-8999
(FAX) 215-993-1220
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