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Registry Overview

Eli Lilly and Company, the manufacturer of Cymbalta, has established a voluntary Pregnancy Registry to learn more information about pregnant women who have taken Cymbalta during pregnancy, the outcome of the pregnancies, and their babies. The primary goal of this Pregnancy Registry is to estimate the risk of major birth defects and other adverse pregnancy outcomes among pregnancies exposed to Cymbalta. Information gathered in this registry may supplement other sources of data and assist clinicians and patients in weighing the risks and/or benefits of being treated with Cymbalta around the time of conception and during pregnancy.

This drug is not approved for use during pregnancy. Cymbalta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because the safety of Cymbalta in infants is not known, nursing while on Cymbalta is not recommended. Women should notify their doctor if they become pregnant, plan to become pregnant, or are breast-feeding during Cymbalta therapy.

Cymbalta is not provided by the Registry. Due to the observational nature of this registry, participation in the Registry will not influence or interfere with the treatment plan recommended by the patient's health care provider.

The success of the Registry depends on the continued participation of healthcare providers and pregnant women who have been treated with Cymbalta. Thank you for your time and participation.

Eligibility and Enrollment

  • You must be at least 18 years old, a U.S. resident, pregnant, and have been treated with Cymbalta during pregnancy
  • The patient or health care provider must contact the Registry to initiate enrollment (Contact Us )
  • Enrollment is voluntary and patients must provide consent. We encourage patients to enroll as early as possible
  • Patients should click on the Patient link for details on their Registry participation
  • Healthcare Providers should click on the Healthcare Providers link for details on Registry participation

Contact Information

This Registry is sponsored by Eli Lilly and Company and is managed by INC Research. Women who are interested in enrolling or would like additional information should click on the Contact Us  link.

For general information about Cymbalta, please refer to following links located on each site page: Prescribing Information , Safety Information and Boxed Warning, Medication Guide, Product Infomation.
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