Who is eligible to enroll?
- The individual must be at least 18 years old, a U.S. resident, pregnant, and have been treated with Cymbalta during pregnancy
- The pregnant individual must have physicians who can provide information about the individual’s and infant’s progress
- In order for the Registry to collect the best data possible, it is 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
- A woman who has taken one or more doses of Cymbalta while pregnant is eligible
What are the patient participation steps?
Step 1: The patient will contact the Registry (Contact Us) and the Registry personnel will provide the patient with information on the goals, eligibility, requirements, and procedures.
Step 2: The patient will be asked to give her consent (Patient Information Sheet) to participate in the Registry, sign medical releases (OB Release Form and Pediatric Release Form), and provide the Registry with her healthcare provider contact information.
Step 3: The patient will receive a $25 inconvenience fee at initial registration, and $25 at the time of the outcome report. Payment will be made by mailed check.
Step 4: The Registry personnel collects general information about patient history and pregnancy from the patient at enrollment and confirms it with the health care provider to complete registration.
Step 5: During the patient’s participation in the registry, the patient’s healthcare provider will contact the patient to obtain the following Information Collected:
- Information on the pregnancy at the end of the second trimester and at the end of the pregnancy
- Information about the infant at birth, 4 months of age, and 12 months of age
- If the mother is breast-feeding, information on breast-feeding at 3, 6, 9, and 12 months after birth
Step 6: The healthcare provider is responsible for completing the Data Forms and sending the data forms to the Registry at the designated timepoints.
Indications and Important Safety Information
Cymbalta is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Cymbalta belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).
Cymbalta is also used to treat or manage:
- Generalized Anxiety Disorder (GAD)
- Diabetic Peripheral Neuropathic Pain (DPNP)
- Fibromyalgia (FM)
- Chronic Musculoskeletal Pain
Important Safety Information for Cymbalta®
The most important information you should know about Cymbalta:
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.
- Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.
- 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. Risk of bleeding or bruising may increase especially if Cymbalta is taken with blood thinners, non-steroidal anti-inflammatory drug (NSAID) pain relievers (like ibuprofen or naproxen), or aspirin. Use of Cymbalta in the month before delivery may increase your risk of bleeding immediately after delivery.
- 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 death
- aspirin, NSAID pain relievers (like ibuprofen or naproxen), 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. Cymbalta may harm your unborn baby. Talk to your healthcare provider about to risks to your unborn baby if you take Cymbalta during pregnancy.
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Cymbalta.
- If you are breastfeeding or plan to breastfeed. Cymbalta passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby while taking Cymbalta.
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.
DD CON ISI 09OCT2019