What is The Cymbalta Pregnancy Registry?
Why is this Registry important?
What does my participation involve?
What is the Cymbalta Pregnancy Registry?
The Cymbalta (duloxetine hydrochloride) Pregnancy Registry is a voluntary, follow-up Registry of pregnant women who are treated with Cymbalta during pregnancy and their babies.
Women who are interested in enrolling may contact the Registry directly by dialing 1-866-814-6975. This Registry is sponsored by Eli Lilly and Company and is managed by Kendle International Inc.
The Registry is designed to monitor pregnant women who are treated with Cymbalta and their babies who may have been exposed to Cymbalta during pregnancy.
Why is this registry important?
Cymbalta is not FDA approved for use during pregnancy, and there is limited information about the safety of taking Cymbalta while pregnant. This Pregnancy Registry has been established to learn more about pregnant women who are treated with Cymbalta during pregnancy and their babies.
A woman may become pregnant while taking Cymbalta or circumstances may occur during pregnancy for which Cymbalta may be considered as a potentially helpful treatment. The decision to stop, start, or continue using Cymbalta during pregnancy should be based upon whether the potential benefit to the mother outweighs any potential risk to the baby. These decisions should be made in consultation with your doctor.
This Pregnancy Registry allows us to follow pregnancies in patients who have been treated with Cymbalta, despite the pregnancy warning/precaution in the package insert. It will help us learn more about the health of babies who have been exposed to Cymbalta during pregnancy. The information gathered in this Registry may supplement other sources of data and assist doctors and patients in weighing the risks and/or benefits of taking this medication during pregnancy.
To be eligible for this Registry, you must be at least 18 years old, a U.S. resident, pregnant and have been treated with Cymbalta during pregnancy, and provide consent. Enrollment is voluntary. We encourage patients to enroll as early in pregnancy as possible.
What does my participation involve?
When you contact the Registry, our goals and procedures will be explained to you. If you are eligible to participate, you will be asked to enroll and provide consent for the release of your medical information from your doctor and your baby’s doctor. Your participation in the Registry will not change the treatment plan you and your doctor have agreed upon.
Your participation may help other patients like you in the future. Information from this Registry, along with other sources of data, may aid doctors and patients in weighing the risks and/or benefits of Cymbalta treatment during pregnancy.
If you are eligible to participate and would consider contributing to this Registry, we encourage you to call the Registry Coordinating Center at 1-866-814-6975.
The success of the Registry depends on the continued participation of pregnant women who have been exposed to Cymbalta. Support and Information contributed by participating patients and providers is greatly appreciated.