Savella for Fibromyalgia

Savella (milnacipran) was FDA-approved in January 2009 as a fibromyalgia treatment. At that time, it was a new drug to the U.S. marketplace. Because it's so new, there's no generic form available yet.

Savella is a serotonin-norepinephrine reuptake inhibitor, or SNRI. By definition, SNRIs are antidepressants. However, Savella isn't approved for depression in the U.S. So far, fibromyalgia is its only approved use in the states.

However, milnacipran is sold in Europe under several brand names, including Dalcipran, Ixel, and others. Milnacipran drugs have been available in foreign markets for more than a decade and are approved for depression in more than 50 countries.

Savella increases levels of the neurotransmitters serotonin and norepinephrine, which can be low in people with fibromyalgia. That puts it in the same class as Cymbalta, which is FDA-approved for fibromyalgia, neuopathic pain, depression, and a handful of other conditions.

Savella, however, is the reported to increase norepinephrine more than serotonin.

The New Drug Application for Savella, filed in December of 2007, included data from two Phase III trials involving more than 2,000 patients. The company says data showed Savella was more effective than a placebo and was well tolerated. There were no deaths during the course of the studies and the majority of side effects were described as mild to moderate.

Later studies have supported early results, showing a significant improvement in symptoms, including pain, fatigue, and sleep. However, a 2015 review concluded that it's only effective for about 40 percent of those who take it. (That's similar to the effectiveness rates for Cymbalta and the other FDA-approved fibromyalgia drug, Lyrica.)

The recommended dosage of Savella is 100 mg or 200 mg per day, split into two doses. It's typical to start at a smaller dosage and gradually work up to the full amount.

It's not safe to suddenly stop taking Savella. If you want to go off of the drug, be sure to talk to your doctor about the proper weaning procedure.

Like all drugs, Savella can cause some unpleasant side effects. Not everyone gets them, but you should be aware of what they are when you start taking this drug. Some of the side effects can be serious.

Get medical help right away if you have any of the following symptoms:

• severe allergic reaction (rash, hives itching, difficulty breathing, tightness in the chest, swelling of the face, lips or tongue)
• bizarre behavior
• bloody or black tarry stools
• confusion
• dark urine
• excessive sweating
• fainting
• rapid or irregular heartbeat
• fever
• chills
• persistent sore throat
• hallucinations
• loss of coordination
• memory problems
• muscle pain or weakness
• new or worsening agitation, anxiety, depression, panic attacks, aggression, impulsiveness, irritability, anger, restlessness or inability to sit still
• pale stools
• red, swollen, blistered or peeling skin
• seizures
• severe or persistent headache or dizziness
• severe or persistent nausea
• vomiting or diarrhea
• severe or persistent trouble sleeping
• stomach pain
• suicidal thoughts or behaviors
• tremor
• trouble urinating
• unusual bruising or bleeding
• unusual or severe mental or mood changes
• unusual weakness
• yellowing of the skin or eyes (jaundice)

Side effects that don't generally require medical attention include:

• constipation
• decreased sexual desire or performance
• dizziness
• dry mouth
• headache
• hot flushes
• increased sweating
• loss of appetite
• nausea
• trouble sleeping

It's possible for drugs to interact negatively with each other. Talk to your doctor and/or pharmacist about all of your medical conditions and possible interactions with other drugs you may be taking.

We never know what drug(s) will help us until we try them. If you want to try Savella, talk to your doctor about the pros and cons and make the decision together.