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.
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.
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