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The Pregnancy Registry for GARDASIL® has been established by Merck & Co., Inc. to collect information on the pregnancy outcomes of women who inadvertently receive GARDASIL® within 1 month prior to or at anytime during pregnancy. The registry receives voluntary reports from health care providers or consumers about women who were given GARDASIL® during pregnancy.
GARDASIL® is Pregnancy Category B. Animal reproductive toxicology studies have revealed no evidence of impaired female fertility or harm to the fetus due to GARDASIL®. However, because there are no adequate and well-controlled studies in pregnant women, and animal reproduction studies are not always predictive of human response, GARDASIL® is not recommended for use in pregnant women.1
In clinical studies, women underwent urine pregnancy testing prior to administration of each dose of GARDASIL®. Women who were found to be pregnant before completion of a 3-dose regimen of GARDASIL® were instructed to defer completion of their vaccination regimen until resolution of the pregnancy. Such non-standard regimens resulted in Postdose 3 anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 responses that were comparable to those observed in women who received a standard 0, 2, and 6 month vaccination regimen (see DOSAGE AND ADMINISTRATION).
During clinical trials, 2,266 women (vaccine = 1,115 vs. placebo = 1,151) reported at least one pregnancy. Overall, the proportions of pregnancies with an adverse outcome were comparable in subjects who received GARDASIL® and subjects who received placebo.
Further sub-analyses were done to evaluate pregnancies with estimated onset within 30 days or more than 30 days from administration of a dose of GARDASIL® or placebo. For pregnancies with estimated onset within 30 days of vaccination, 5 cases of congenital anomaly were observed in the group that received GARDASIL® compared to 0 cases of congenital anomaly in the group that received placebo. Conversely, in pregnancies with onset more than 30 days following vaccination, 10 cases of congenital anomaly were observed in the group that received GARDASIL® compared with 16 cases of congenital anomaly in the group that received placebo. The types of anomalies observed were consistent (regardless of when pregnancy occurred in relation to vaccination) with those generally observed in pregnancies in women aged 16 to 26 years.
Thus, there is no evidence to suggest that administration of GARDASIL® adversely affects fertility, pregnancy, or infant outcomes.2
Merck & Co., Inc. maintains a registry to monitor the pregnancy outcomes of women exposed to GARDASIL® while pregnant. 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.
Enrollment:
Enroll your patient by completing the simple one-page enrollment form available below or call 1-800-986-8999.
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 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., Canada
and France)
- Exposure to GARDASIL® during pregnancy (within 1 month prior to or at anytime after the woman’s last menstrual period)
- Name of a health care provider (to obtain diagnoses and 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
Aggregate data 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 administering GARDASIL®.
Pregnancy Registry for GARDASIL®
Phone: 1-800-986-8999
Fax: 215-993-1220
1 Merck & Co., Inc. Worldwide Product Circular for Gardasil, August, 2006: p. 3.
2 Merck & Co., Inc. Worldwide Product Circular for Gardasil, August, 2006: p. 3-4.
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