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.
- 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.
- 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 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:
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).
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.
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.
- attempts to commit suicide
- acting on dangerous impulses
- acting aggressive, being angry, or violent
- thoughts about suicide or dying
- new or worsening depression
- new or worsening anxiety
- panic attacks
- feeling very agitated or restless
- new or worsening irritability
- trouble sleeping
- an extreme increase in activity or talking (mania)
- other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?
- Never stop or change your dose of an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.
- Antidepressant medicines have other side effects. Talk to your healthcare provider about the side effects of the medicine prescribed for you or your family member.
- Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider.
Cymbalta is not for everyone. Do not take Cymbalta if you:
- take a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid and intravenous methylene blue. Taking Cymbalta close in time to these medicines may have a serious or even life-threatening problem called Serotonin Syndrome.
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.
- Decreased blood pressure upon standing, which can cause falls, dizziness or fainting, mostly when first starting or increasing the dose. Elderly patients reported more falls.
- 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 blood thinners, NSAID pain relievers (like ibuprofen or naproxen), or aspirin.
- 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. Only some people are at risk for these problems, so 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
- 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.
Before taking Cymbalta, talk with your healthcare provider:
About all your medical conditions, including:
- heart problems or high blood pressure
- diabetes (Cymbalta makes it harder for some people with diabetes to control blood sugar)
- kidney or liver problems
- bipolar disorder or mania
- 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
- thioridazine (Mellaril) to avoid a serious heart rhythm problem or sudden deathaspirin, 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 breastfeeding or plan to become pregnant or breastfeed during therapy
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:
- 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. 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 04DEC2014