Information Collected

What information is collected by the Registry?

The Registry collects information from the patient at enrollment and confirms it with the health care provider. Follow-up information is requested from the obstetrical provider at the end of the second trimester and the end of the pregnancy. Additional information is requested from the pediatric provider at birth, 4 months, and 12 months. The patient is also contacted for breast-feeding information at 3, 6, 9, and 12 months after birth, as applicable.

Information Collected:

Because this Registry is an FDA required post-marketing safety study, it is exempt from HIPAA regulations (45 CFR-164.512). The Registry does require an abbreviated consent document, which is completed by a clinical research associate over the phone (i.e., an authorization for release of medical information and release forms). The IRB has granted a waiver of documentation of informed consent, allowing patients to provide this verbal consent to participate without a written signature.

How are data collected by the Registry?

Enrollment in the Registry is strictly voluntary. The patient can initiate the enrollment process by calling the Registry and providing verbal consent for participation and for contacting her healthcare provider(s). Once the patient provides her verbal consent, data can be collected for enrollment. The patient’s obstetric healthcare provider is then contacted to confirm his or her willingness to provide follow up regarding the patient’s pregnancy. Alternatively, the healthcare provider can initiate enrollment with a conversation about the Registry with the patient. The healthcare provider has access to the Registry forms and may consent the patient in his or her office and send the completed forms to the Registry. Subsequent follow-ups with the healthcare provider and/or patient will be initiated from the Registry.

In order for the Registry to collect the best data possible, it is extremely important for eligible patients to be enrolled early in pregnancy, preferably before any prenatal testing has been conducted. However, eligible patients at any trimester of pregnancy may enroll.

Data is collected by the Registry Coordinating Center on Registry data collection forms. Click on contact us for more information about contacting the Registry Coordinating Center. Click on the Data Forms link to see the detailed data entry forms.

How are data analyzed and reported?

The Registry plans to produce an interim report for participating Health Care Providers every 12 months to share the most current information from this ongoing Registry. This reporting schedule is contingent upon the level of enrollment. The interim report will continue to evolve as more data are collected and analyzed

An important aspect of The Cymbalta Pregnancy Registry is the Scientific Advisory Committee (SAC) formed to oversee the collection and analysis of Registry data and the presentation of results. This independent SAC is composed of recognized experts in the fields of teratology, epidemiology, maternal and fetal medicine, and therapeutic areas of interest, from the CDC, academia, and private practice. The Committee’s membership also includes non-voting representatives from Eli Lilly and Company and Syneos Health. The SAC will advise on the Registry, as well as review and provide interpretation and reporting of the cumulative data on an ongoing basis.

Indications and Important Safety Information

Indications

Cymbalta is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Cymbalta belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).

Cymbalta is also used to treat or manage:

Important Safety Information for Cymbalta®

The most important information you should know about Cymbalta:

Antidepressants can increase suicidal thoughts and behaviors in children, teens, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Call your doctor right away or seek emergency help if you have new or worsening depression symptoms; unusual changes in behavior, such as agitation, irritability, impulsivity, or restlessness; or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose.

The most important information you should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions:

  1. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness).
  2. How can I watch for and try to prevent suicidal thoughts and actions?
    • Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. This is very important when an antidepressant medicine is started or when the dose is changed.
      • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider right away if you have any of the following symptoms or feelings, especially if they are new, worse, or worry you. In an emergency, call 911.

What else do I need to know about antidepressant medicines?

Cymbalta is not for everyone. Do not take Cymbalta if you:

Cymbalta may be associated with serious side effects. Call your healthcare provider right away or seek emergency help if you experience any of the following:

Before taking Cymbalta, talk with your healthcare provider:

Most common side effects of Cymbalta (this is not a complete list):

Nausea, dry mouth, sleepiness, fatigue, constipation, decreased appetite, increased sweating, and dizziness. Common side effects for children and adolescents who take Cymbalta include nausea, decreased weight, and dizziness. Side effects in adults may also occur in children and teens who take Cymbalta. Children and adolescents should have height and weight monitored during treatment.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Other safety information about Cymbalta:

How to take Cymbalta:

Take Cymbalta exactly as directed by your healthcare provider. Swallow Cymbalta whole; do not open, break, or chew capsule.
Cymbalta is available by prescription only.

See Prescribing Information, including Boxed Warning about antidepressants and risk of suicide, and Medication Guide.

DD CON ISI 09OCT2019