Forest Laboratories, Inc. (Forest), on behalf of Cypress Biosciences, Inc., has established this voluntary Pregnancy Registry to learn about the pregnancy outcomes of women who have taken Savella (milnacipran HCl) during pregnancy. In the future, the information gathered in this Registry may supplement other sources of data and assist clinicians and patients in weighing the risks and benefits of being exposed to Savella around the time of conception and during pregnancy. This drug is not approved for use during pregnancy. Women should notify their doctor if they become pregnant during therapy or intend to become pregnant during therapy. There are no adequate and well-controlled studies in pregnant women. Savella should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

 

The Savella Pregnancy Registry is a voluntary Registry for women exposed to Savella during pregnancy. Women interested in enrolling may contact the Registry directly by calling 1-877-643-3010. This Registry is sponsored by Forest and is managed by Kendle International Inc.

 

The goal of this Pregnancy Registry is to estimate if, and how often, birth defects, and any other serious adverse pregnancy outcomes, occur among pregnancies exposed to Savella. Mothers are followed until the end of their pregnancies and their live-born infants are followed until age one.

 

Participation in the Registry will not influence or interfere with the treatment plan recommended by the patient's healthcare Provider. The Registry strictly observes patients who participate.

 

If you are interested in additional information, click on contact us for the Registry Coordinating Center.

 

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Thank you in advance for your time and participation. We welcome any questions you may have regarding the Savella Pregnancy Registry.

 

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Savella (milnacipran) is indicated for the management of fibromyalgia in adults. Savella is available by prescription only.

 

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Important Risk Information About Savella

 

Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Patients on antidepressants and their families or caregivers should watch for new or worsening symptoms, unusual changes in behavior, 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 whenever there is a change in dose, either increase or decrease. Savella is not approved for use in treating depression.

 

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Who should NOT take Savella?

 

Do not take Savella if you:

Are taking or have recently taken a type of drug

called a monoamine oxidase inhibitor (MAOI), such as Nardil® (phenelzine sulfate) or Parnate® (tranylcypromine sulfate)

Have uncontrolled narrow-angle glaucoma

(an eye disease)

 

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What should I tell my healthcare provider before taking Savella?

 

Before starting Savella, tell your healthcare provider about all of your medical conditions, including if you have:

 

Hypertension (high blood pressure), tachyarrhythmia

(fast heart rate), or other cardiac diseases

Liver problems or a history of substantial alcohol use

Kidney problems, including dysuria (painful

urination)

History of mania or seizure disorders

Bleeding disorders

Glaucoma

Also, to avoid a potentially serious or life-threatening condition, tell your healthcare provider if you are taking, or planning to take, any prescription or over-the-counter medications, including:

Other SNRIs, serotonin reuptake inhibitors

(SSRIs), certain migraine or headache medications (triptans), or tryptophan

Medication prescribed for a psychiatric or

neurological condition

NSAID pain relievers (such as ibuprofen or

naproxen), aspirin, warfarin, or other blood thinners

Diuretics

Tell your healthcare provider if you are pregnant, planning to become pregnant during therapy, or are breastfeeding.

 

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What other important information should I discuss with my healthcare provider?

 

Your blood pressure and pulse should be monitored at regular intervals when receiving treatment with Savella.

 

You should not operate machinery or drive until you are reasonably certain that Savella treatment does not affect your ability to engage in such activities. Avoid drinking alcohol while taking Savella.

 

Call your doctor if you have very high fever, rigid muscles, shaking, confusion, or rapid changes in heart rate and blood pressure. These may be signs of a rare but serious side effect.

 

Talk with your healthcare provider before stopping Savella or changing your dose. Withdrawal symptoms can occur, particularly when discontinuation is abrupt.

 

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What are the possible side effects of Savella?

 

The most common side effect associated with Savella treatment is nausea. In clinical trials, patients experiencing nausea described it as mild to moderate. Other common side effects were headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis (excessive sweating), vomiting, palpitations, increased heart rate, dry mouth, and hypertension.

 

This is not a complete list of side effects.

 

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