Enrollment

REBETOL®
(ribavirin)
CRIXIVAN®
(indinavir sulfate)
ISENTRESS®
(raltegravir)
GARDASIL®
[Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine]
JANUVIA®
(sitagliptin phosphate)
JANUMET®
(sitagliptin/metformin HCl)
MAXALT®
(rizatriptan benzoate)
SINGULAIR®
(montelukast sodium)
VARICELLA ZOSTER VIRUS-CONTAINING VACCINES


 

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:

  1. A report of pregnancy from a patient or health care provider (U.S. residents only)
  2. Exposure to MAXALT during pregnancy (anytime after the woman's last menstrual period)
  3. Name of a health care provider (to confirm diagnoses and to obtain outcome information)
  4. 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.

Pregnancy Registry for MAXALT
1-800-986-8999

(FAX) 215-993-1220

 

Enrollment form for MAXALT
Patient consent form for MAXALT
Spanish patient consent form for MAXALT
Request for the Annual Report form for MAXALT
Package insert for MAXALT
Patient package insert for MAXALT

Or call 1-800-986-8999 to enroll a patient, report an outcome of pregnancy, request an annual report, or request any of the above forms.


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