Welcome!

This information on pregnancy registries is intended for healthcare providers and patients who wish to enroll a pregnancy already exposed to a certain GSK prescription medicine or vaccine into an exposure registry.

GSK conducts ongoing observational studies – known as pregnancy registries or pregnancy exposure studies - in consultation with the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) or the European Medicines Agency (EMEA) to track the effects of certain medicines on pregnancy outcomes when mothers have been exposed to medicines at any time during pregnancy. Vaccine pregnancy registries are programs of enhanced safety surveillance. Enrollment of pregnant women into these ongoing studies who have been already exposed to these products is encouraged to gather information that can help inform future treatment decisions for healthcare professionals and pregnant women. Interim results from the drug pregnancy registries are available to healthcare professionals to supplement animal toxicology studies and to assist clinicians in caring for their patients.

   To Report a potential Side Effect or Adverse Event including
   Pregnancy Exposure, Contact us by phone, email or post

	Phone: 1-888-825-5249 (toll-free)
	Email: us.naps@gsk.com
	Fax: +1 919 287 2902
	Post: GSK PO Box 13398 Research Triangle Park, NC 27709-9627

GSK PREGNANCY REGISTRIES

Except where noted below, there are insufficient data on the use of the GSK medicines/vaccines listed below in pregnant women to inform a drug associated risk. Medicines/Vaccines should be used during pregnancy only if the potential benefit justifies the potential risk. Patients should speak with their healthcare professional with any questions concerning medications during pregnancy.

Only RETROVIR^® (zidovudine, AZT) after the first trimester is approved for use during pregnancy. See prescribing information for details including important safety information.

To learn more about our Pregnancy Registries or to learn how you or your patient can participate if a pregnancy has been exposed, select the registry of interest below. GSK works with PPD Inc and Organization of Teratology Information Specialists (OTIS) Research Center to operationalize our pregnancy registries.

ONGOING PREGNANCY REGISTRIES

• Antiretroviral Pregnancy Registry


• Mepolizumab Pregnancy Registry


• Boostrix^® Pregnancy Registry


• Varilrix^™ Pregnancy Registry


• Priorix^™ Pregnancy Registry


• Menveo^™ Pregnancy Registry


• Bexsero^™ Pregnancy Registry


• Sotrovimab^™ Pregnancy Registry

CLOSED PREGNANCY REGISTRIES
(Final Study Report Available):

• Lamotrigine Pregnancy Registry


• Bupropion Pregnancy Registry


• Acyclovir and Valacyclovir Pregnancy Registries


• Sumatriptan/Naratriptan/Treximet Pregnancy Registry


• Twinrix^® Pregnancy Registry


• Belimumab Pregnancy Registry

(The final study report for the belimumab will be available in Q2 2023)

ADDITIONAL RESOURCES

• FDA Women’s Health Information


• CDC Pregnancy and Medicines/Vaccines


• EMEA Post-Authorization Safety Study (PASS)