Are you pregnant and taking medicines? FDA encourages women like you to participate in pregnancy exposure registry studies that track the outcomes of pregnancies in which medicines were taken during pregnancy.
We are joined today by Dr. Marjorie Jenkins, Director of Scientific Engagement and Medical Initiatives for FDA’s Office of Women’s Health. Dr Jenkins joined the FDA Office of Women’s Health (OWH) in 2015. In her role as OWH Director of Medical Initiatives and Scientific Engagement, Dr. Jenkins provides sex and gender-specific women’s health scientific expertise within research, health education, and communications initiatives. Dr. Jenkins will tell us why pregnancy exposure registries are so important.
What are pregnancy exposure registries?
A pregnancy exposure registry is a study that collects health information from women who take prescription medicines or vaccines when they are pregnant. The study also collects information on the health of the newborn baby. This information is compared with women who have not taken medicine during pregnancy. The information is used to learn more about the effects of medicines and vaccines taken during pregnancy.
Why are pregnancy exposure registries important?
About half of all pregnant women report taking at least one medication during pregnancy. Many women have health problems like high blood pressure, arthritis or epilepsy, and they need to continue to take prescription medicine when they are pregnant. Other women take medicine before they realize they are pregnant.
Pregnancy exposure registries are one way that we can learn more about the safety of medicines and vaccines.
By enrolling in a pregnancy exposure registry, you can help other pregnant women and doctors find out more about medicines’ and vaccines’ safety in pregnancy. The safety information collected in the registry may be used to update medical product labeling.
Does FDA conduct pregnancy exposure registries?
No. FDA does not run the pregnancy exposure registry studies. The drug company that makes the medicine/vaccine or a research institution is usually in charge of the pregnancy exposure registry.
FDA keeps a list of ongoing registries on the FDA Pregnancy Registry website. The website may not represent a comprehensive list of all available pregnancy exposure registries. FDA does not endorse any registry and is not responsible for the content of registries listed.
Where can a pregnant woman find more information about a registry and how to participate?
It is a requirement that prescription medicine and vaccine labeling include information about the existence of a pregnancy registry. The Pregnancy subsection includes the contact information for the pregnancy exposure registry.
The FDA Office of Women’s Health created a website to help connect pregnant women and health professionals to pregnancy registries. The website includes a list of registries with the contact information that you can use to sign up for each registry.
There are instructions on the website to help you find out if there is a registry for your medicine or vaccine. You can search for a registry using the name of the medicine or vaccine or your medical condition.
What happens when you sign up for a registry?
Each registry has its own procedures about how they contact you and what you need to do to participate. The registry may contact you a few times during pregnancy and after you have had your baby to ask questions about you and your baby’s health. The calls can be as short as 10-15 minutes.
You will not be asked to take any new medicines to participate in the registry. The pregnancy exposure registry is only interested in medicines that you are already taking.
Thank you for the opportunity to talk about pregnancy exposure registries. I hope that you will visit www.fda.gov/pregnancyregistries to learn more about how you can sign up to share your experiences.