About The Savella Pregnancy Registry
The purpose of the Savella Pregnancy Registry is to gain knowledge of the effects of taking Savella during pregnancy. Enrollment in the Registry is voluntary, and may help future mothers better understand the risks and benefits of using Savella during pregnancy.
If you are pregnant and have received Savella, you may qualify to participate. The Pregnancy Registry seeks participants who:
- Have taken Savella anytime during pregnancy.
- Are pregnant now.
- Are residents of the United States.
- Are 18 years old or older.
- Will allow us to contact their doctor and their baby’s doctor for information.
You will be asked to provide some basic information about your pregnancy and for your permission to contact:
- the doctor who prescribed Savella
- the doctors you are seeing during this pregnancy and
- your baby’s doctor after the delivery
It is important for eligible patients to be enrolled in this Registry as early in pregnancy as possible. However, eligible patients may enroll at any time during their pregnancy. It may also be possible for a woman who is no longer pregnant to enroll, if specific criteria are met. Please call the registry to discuss what these criteria are.
Participation in this Registry does not require any additional medical procedures, or taking any additional medications. It will not affect your treatment plan agreed upon between you and your doctor in any way.
What Kind of Information is the Registry Collecting?
The Registry will need information about you, your pregnancy, and your baby after delivery. All information collected will be confidential – you and your baby’s identity will be protected. We will ask you about your use of Savella and any other medications you are taking during pregnancy. Your doctor will be asked to provide information about your health history, including any previous pregnancies, and any risks related to your pregnancy. Additionally, your baby’s pediatrician will be asked to provide information about your child’s health through 12 months of age.
Why Should I Participate?
The results of this Registry is intended to increase the overall knowledge about the effects of using Savella during pregnancy. Registering is quick, easy, and completely voluntary. No extra doctor visits, no extra tests, no extra medications.
- Register! – Answer a few basic questions about yourself and enter your contact information below.
- Expect a Representative to Contact You – After you enter your contact information below, a Registry Representative will contact you to provide additional information, answer any questions you may have and complete the registration process.
- Obtain More Information – To see an example of the forms related to participation in the Registry, click here.
If you are interested in this registry please see the information below:
Your input is greatly appreciated!
The success of this Registry depends on the participation of pregnant women who have taken Savella for the treatment of fibromyalgia. Thank you for registering with us today!
A representative will contact you soon; if you’re not contacted within 3 days, please call 1-844-726-3512
SAVELLA (milnacipran HCl) is indicated for the management of fibromyalgia in adults. SAVELLA is not approved for use in pediatric patients. SAVELLA is available by prescription only.
Important Risk Information About Savella
- SAVELLA is not used to treat depression, but it acts like medicines that are used to treat depression (antidepressants) and other psychiatric disorders.
- Antidepressants may increase suicidal thoughts or actions in some children, teenagers, and young adults.
- Call your doctor right away or seek emergency help if you have new or worsening additional symptoms, unusual changes in behavior, mood, thoughts or feelings, thoughts of suicide, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity.
- Call your healthcare provider right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of treatment or after a change in the dose.
- SAVELLA is approved only for adults aged 18 and older.
- For more information about this risk, please read the SAVELLA Patient Medication Guide in the full Prescribing Information.
SAVELLA may be associated with serious side effects. Call your healthcare provider right away or seek emergency help if you experience any of the following symptoms:
- Agitation, hallucinations, muscle twitching, sweating or fever, stiff muscles, dizziness, or diarrhea; these may be signs of serotonin syndrome, a potentially life-threatening condition.
- Increase in blood pressure or heart rate. Your healthcare provider should check your blood pressure and heart rate before starting and throughout SAVELLA treatment. Before starting SAVELLA, tell your doctor if you have high blood pressure or problems with your heart or blood vessels (cardiovascular disease).
- Seizures or convulsions.
- Itching, right upper-belly pain, dark urine, yellow skin or eyes, or unexplained flu-like symptoms, which may be signs of life-threatening liver problems.
- Headache, weakness, confusion, problems concentrating or memory problems may be signs of low salt levels in the blood. Elderly people may be at greater risk.
- Abnormal bleeding, especially if SAVELLA is taken with other medicines such as the blood thinner warfarin, NSAID pain relievers (ibuprofen or naproxen), or aspirin.
- Manic episodes, which may include greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, unusually grand ideas, excess happiness or irritability, and talking more or faster.
- Problems with urination, which may include decreased urine flow or inability to pass urine.
- Visual problems: Eye pain; changes in vision; swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are
Do not stop SAVELLA without first talking to your healthcare provider. Stopping SAVELLA too quickly may cause serious symptoms, including:
- anxiety, irritability, or confusion
- feeling tired or problems sleeping
- headache, dizziness, seizures
- electric shock-like sensations, ringing in ears
SAVELLA is not for everyone. Do not take SAVELLA if you:
- Take a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid. Taking SAVELLA close in time to these medications can cause serious or even life-threatening side effects.
Before starting SAVELLA, tell your healthcare provider:
- About all your prescriptions and over-the-counter medicines and supplements you take or plan to take including:
- Medicines for migraines, mood, or psychotic disorders to avoid a potentially life-threatening condition
- Aspirin, NSAID pain relievers, or blood thinners, because they may increase the risk for bleeding
- About how often and how much alcohol you drink.
- If you are pregnant or plan to become pregnant during therapy or breast-feeding.
Other Safety Information related to SAVELLA:
- SAVELLA may cause sleepiness and dizziness. Until you know how SAVELLA affects you, you shouldn’t drive a car or operate hazardous machinery.
Most common side effects of SAVELLA:
- Nausea, headache, constipation, dizziness, insomnia, hot flush, excessive sweating, vomiting, palpitations, increased heart rate, dry mouth, and increased blood pressure. This is not a complete list.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/Safety/Medwatch, or call 1-800-FDA-1088.