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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 breastfeeding 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 if you have new or worsening depression symptoms, unusual changes in behavior, 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® (duloxetine HCl) is not for everyone. Do not take Cymbalta if you:

  • have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI) or Mellaril® (thioridazine)
  • have uncontrolled narrow-angle glaucoma (increased eye pressure)

Before taking Cymbalta, talk with your healthcare provider:

  • about all your medical conditions, including kidney or liver problems, glaucoma, diabetes, seizures, or if you have bipolar disorder. Cymbalta may worsen a type of glaucoma or diabetes
  • about all your prescription and nonprescription medicines. A potentially life-threatening condition has been reported when Cymbalta was taken with certain drugs for migraine, mood, or psychotic disorders
  • if you are taking NSAID pain relievers, aspirin, or blood thinners. Use with Cymbalta may increase bleeding risk
  • about your alcohol use
  • about your blood pressure. Cymbalta can increase your blood pressure. Your healthcare provider should check your blood pressure prior to and while taking Cymbalta
  • if you are pregnant or plan to become pregnant during therapy, or are breast-feeding

While taking Cymbalta, talk to your healthcare provider right away:

  • if you have itching, right upper-belly pain, dark urine, yellow skin/eyes, or unexplained flu-like symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, have been reported
  • if you have high fever, confusion and stiff muscles, which may be symptoms of a potentially life-threatening condition
  • if you have skin blisters, serious or peeling rash, hives, mouth sores, or any other allergic reaction. These may be serious, possibly life-threatening, skin reactions
  • if you experience dizziness or fainting upon standing. This tends to occur in the first week or when increasing the dose, but may occur at any time during treatment
  • before you stop Cymbalta or change your dose
  • if you experience headache, weakness, confusion, problems concentrating, memory problems, or feel unsteady, which may be signs of low sodium levels
  • if you develop problems with urine flow

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

  • nausea, dry mouth, sleepiness, fatigue, constipation, dizziness, decreased appetite, and increased sweating
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 should not 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. Cymbalta should be taken by mouth. Do not open, break or chew capsule; it must be swallowed whole. Cymbalta can be taken with or without food.

Cymbalta is available by prescription only.

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

DD CON ISI 28NOV2011