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:

  • Maternal demographic information, reproductive history, concurrent medical conditions, and concomitant medications/exposures
  • Prenatal testing information
  • Health Care Provider contact information
  • Cymbalta therapy information (daily dose, start date, stop date relative to conception, etc.)
  • Familial history of birth defects
  • Pregnancy outcome information (live birth, stillbirth, miscarriage, etc.)
  • Infant birth data and findings
  • Assessment of infant growth and development and physical exam findings at 4 months and 12 months
  • Breast-feeding assessment at 3, 6, 9, and 12 months
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 INC Research, LLC. 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
  • Cymbalta is indicated for the treatment of Major Depressive Disorder (MDD). The efficacy of Cymbalta was established in 4 short-term trials and 1 maintenance trial in adults
  • Cymbalta is indicated for the treatment of Generalized Anxiety Disorder (GAD). The efficacy of Cymbalta was established in 3 short-term trials and 1 maintenance trial in adults
  • Cymbalta is indicated for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis
  • Cymbalta is indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy
  • Cymbalta is indicated for the management of fibromyalgia (FM)
Important Safety Information About 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. Approved only for adults 18 and over.

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:

  • Itching, right upper-belly pain, dark urine, yellow skin/eyes, or unexplained flu-like symptoms, which may be signs of life-threatening liver problems. Severe liver problems, some fatal, have been reported
  • High fever, confusion, stiff muscles, muscle twitching, or racing heart rate, which may be signs of serotonin syndrome, a potentially life-threatening condition
  • Abnormal bleeding, especially if Cymbalta is taken with aspirin, NSAID pain relievers (like ibuprofen or naproxen), or blood thinners
  • Serious, possibly life-threatening skin reactions, which may include skin blisters, peeling rash, mouth sores, hives, or other allergic reactions
  • Abnormal mood (mania), which may include greatly increased energy, severe trouble sleeping, racing thoughts, talking more or faster than usual, and reckless behavior
  • Visual problems, including eye pain, changes in vision, and swelling or redness in or around the eye. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are
  • Seizures or convulsions
  • Decreased blood pressure upon standing, which can cause dizziness or fainting, mostly when first starting or increasing the dose. Cymbalta can also increase blood pressure. Your healthcare provider should check your blood pressure prior to and while taking Cymbalta
  • Headache, weakness or feeling unsteady, confusion, problems concentrating, or memory problems, which may be signs of low sodium levels in the blood. Elderly people may be at greater risk
  • Problems with urination, including decreased flow or inability to pass any urine
  • Changes in appetite or weight. Children and adolescents should have height and weight monitored
Do not stop Cymbalta or change your dose without talking to your healthcare provider, as you could have side effects.

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

  • Are taking or have recently taken a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid, or Mellaril® (thioridazine). Taking Cymbalta close in time to these medicines can cause serious or even life-threatening side effects

Before taking Cymbalta, talk with your healthcare provider:

  • About all your medical conditions, including
    • kidney or liver problems, heart problems, or high blood pressure
    • glaucoma or diabetes (Cymbalta may worsen diabetes or a type of glaucoma)
    • seizures/convulsions, mania, or if you have bipolar disorder
    • if you have ever had or been told you have bleeding problems, low sodium levels in your blood, or delayed stomach emptying
  • About all prescription and over-the-counter medicines and supplements you take or plan to take, including
    • antibiotics or medicines for migraine, mood, or psychotic disorders, to avoid a potentially life-threatening condition when taken with Cymbalta
    • aspirin, NSAID pain relievers, or blood thinners, because they may increase risk for bleeding
  • About your alcohol use (you should not take Cymbalta if you drink heavily)
  • If you are pregnant or plan to become pregnant during therapy or are breast-feeding

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

Nausea, dry mouth, sleepiness, fatigue, constipation, decreased appetite, increased sweating, dizziness. 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:

  • Cymbalta may cause sleepiness and dizziness. Until you know how Cymbalta affects you, you shouldn’t drive a car or operate hazardous machinery
  • People age 65 and older who took Cymbalta reported more falls, some resulting in serious injuries

How to take Cymbalta:

Take Cymbalta exactly as directed by your healthcare provider. Do not open, break, or chew capsule; swallow it whole.
Cymbalta is available by prescription only.
 
See Prescribing Information, including Boxed Warning about antidepressants and risk of suicide, and Medication Guide.
 
DD CON ISI 04AUG2014