What is The Cymbalta Pregnancy Registry?
Why is this Registry important?
Why should I have my patients enroll?
What does participation involve?
How can my patients enroll in this Registry?
What is The Cymbalta Pregnancy Registry?
The Cymbalta (duloxetine hydrochloride) Pregnancy Registry is a prospective, observational, exposure-registration and follow-up Registry of pregnant women and their offspring exposed to Cymbalta during pregnancy. Women who are interested in enrolling may contact the Registry directly by calling 1-866-814-6975. This Registry is sponsored by Eli Lilly and Company and is managed by Kendle International Inc. The primary objective of this Pregnancy Registry is to estimate the risk of major birth defects and other adverse pregnancy outcomes among pregnancies exposed to Cymbalta.
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.
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 patient.
This Pregnancy Registry allows us to follow pregnancies in patients who have been treated with Cymbalta. 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.
A health care provider may enroll pregnant patients who have been exposed to Cymbalta while pregnant and are at least 18 years old. We encourage enrollment as early in pregnancy as possible. Patient consent is required for participation in this Registry.
Why should I have my patients enroll?
Information that you provide will add to the body of knowledge for women who are pregnant or contemplating a pregnancy and are taking Cymbalta. In addition, in the future, data from this Registry, supplemented with other sources of data, may aid clinicians and patients in weighing the risks and/or benefits of Cymbalta use during pregnancy.
Please consider enrolling your patients who are pregnant and have been exposed to Cymbalta during their pregnancy.
What does participation involve?
Patient
When your patient contacts the Registry, our goals and procedures will be explained. If she is eligible to participate, she will be asked to give her consent over the phone in order to participate and to sign medical releases for her health care providers to provide information to the Registry.
Health Care Provider
As the physician caring for this patient, you will be asked to provide routinely collected medical information to the Registry on behalf of your patient. No study medication will be given and no extra tests or additional office visits are required. Participation in the Registry will not influence or interfere with the treatment plan you and your patient have agreed upon. We recognize that your time is valuable and make every effort to minimize the time commitment required for participation.
How can my patients enroll in this Registry?
A health care provider may enroll a patient in the Registry if she was exposed to Cymbalta while pregnant. Patient consent is required for participation in this Registry. Please contact us at 1-866-814-6975 for further details.
In addition, your patient may contact the Registry directly to enroll. If you are interested in having your patient enroll and want more information, click on contact us or call us at 1-866-814-6975.For answers to specific questions about Cymbalta, please contact Eli Lilly and Company by dialing 1-800-LillyRx (1-800-545-5979).