Summary:
Have You Been Prescribed EPIDIOLEX® (cannabidiol)?
This is a voluntary observational study to evaluate the pregnancy-related health outcomes in women who have taken at least 1 dose of EPIDIOLEX.
Jazz Pharmaceuticals Research UK Limited, the manufacturer of EPIDIOLEX® (cannabidiol) oral solution, has initiated the Epidiolex Pregnancy Surveillance Program in compliance with the U.S. Food and Drug Administration (FDA) requirements on post-approval pregnancy safety studies.
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.
Eligibility Criteria:
- 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.
In addition, 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 of treatment or care as decided by healthcare providers.