What is a Pregnancy Surveillance Program?
During the development of medical products, women who
are pregnant are typically excluded from clinical trials,
and therefore, limited information is available on the use
of medications during pregnancy. The US Food and Drug
Administration (FDA) mandates pharmaceutical companies to
monitor use of many different medications during pregnancy,
to provide further information. Guidance was issued by the FDA
in 2019 for pharmaceutical companies on pregnancy studies,
including pregnancy surveillance programs.
What is the EPIDIOLEX® Pregnancy
Surveillance Program and why is it
being initiated?
Following the 2019 FDA guidance, Jazz Pharmaceuticals, Inc.,
the manufacturer of EPIDIOLEX® (cannabidiol), is conducting
this observational study to evaluate pregnancy-related
health outcomes in women who have taken at least 1 dose of
EPIDIOLEX in the 13 days before their last menstrual period
prior to pregnancy or anytime during pregnancy and their
babies up to 12 months of age who were exposed to at least
1 dose of EPIDIOLEX in utero. Participants will be asked to
provide health information about their pregnancy and their
infant's growth and development up to their first birthday.
Participation in this study will not impact maternal or infant
standard treatment or care as decided by healthcare providers.
There is another pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to antiepileptic drugs
(AEDs), such as EPIDIOLEX, during pregnancy using a different
study design. The North American Antiepileptic Drug (NAAED)
Pregnancy Registry is a separate study. It is possible to
participate in both studies, or to participate in only one study.
You or your loved one may also choose not to participate in
either study.
Am I (or my loved one) eligible to participate in the study?
If you or your loved one has taken at least 1 dose of EPIDIOLEX
in the 13 days before the last menstrual period prior to
pregnancy or any time during pregnancy, you may be eligible
to participate in this study. You can enroll even if you or your
loved one are no longer pregnant.
How do I (or my loved one) participate in this study?
To learn more about the EPIDIOLEX Pregnancy Surveillance
Program and to find out if you or your loved one are eligible
to participate, please contact a study representative at
855-272-7158. You or your loved one may also ask your
healthcare provider for a referral.
A study representative will describe the study in more detail,
answer any of your questions and ask for verbal consent along
with an optional written release of medical records. Consent
acknowledges understanding of the study, and release of
relevant medical records allows you/your loved one's and
infant's healthcare information to be collected. If you or your
loved one provide consent, a study representative will contact
your/their healthcare provider to confirm personal health
information.
Why should I (or my loved one) participate in this study?
The information collected in this study will be provided
to the FDA so that other women who become pregnant
while being treated with EPIDIOLEX can better understand
any potential effects of EPIDIOLEX on their pregnancy and
their babies.
By participating in this study, you or your loved one will provide
important information that will help Jazz Pharmaceuticals,
Inc. evaluate pregnancy-related health outcomes. You or your
loved one can also choose whether your physician can provide
information as well.
The decision to participate in this study is entirely voluntary.
While enrolled in the study, personal and medical information
will be kept strictly confidential.
What will participation involve if I
(or my loved one) decide to enroll
in the study?
After you or your loved one are enrolled in the study, a study
representative will be in contact at select time points to collect
pregnancy-related health information. If currently pregnant,
you or your loved one will be contacted once during each
trimester, and around the time of estimated delivery date or
when you or your loved one give birth.
If you or your loved one provide consent, a study representative
will also contact your/their healthcare provider(s) at two time
points during the study: approximately at week 34 for prenatal
follow-up and around the time of estimated delivery date, or
when you or your loved one give birth.
In addition, a study representative will contact your/their
infant's pediatrician at four time points during the study: when
the baby is 3, 6, 9, and 12 months of age.
Will my (or my loved one's) privacy be protected?
All personal and medical information will be kept strictly
confidential. Information about your or your loved one's
health while enrolled in the EPIDIOLEX Pregnancy Surveillance
Program will be kept anonymous and any identifying
information will not be used. Patient names will be coded
and not identifiable to the sponsor (Jazz).
