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Savella for Fibromyalgia

FDA Approved Since Jan. 2009

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Updated July 30, 2013

What Savella Is

Savella (milnacipran), a drug new to the U.S., was approved in January 2009 as a fibromyalgia treatment. Made by Forest Laboratories, Inc. and Cypress Bioscience, Inc., Savella is an antidepressant similar to Cymbalta (duloxetine), which was the second drug the FDA approved for treating fibromyalgia (FMS). Savella hit the U.S. market for the first time in late April 2009.

Savella is a serotonin-norepinephrine reuptake inhibitor, or SNRI.

What Savella Does:

Savella, like Cymbalta, increases levels of the neurotransmitters serotonin and norepinephrine, which can be low in people with fibromyalgia. Savella, however, is the first drug 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.

Savella's History:

Milnacipran, the generic name for Savella, is sold in Europe under the brand names Dalcipran and Ixel. Milnacipran drugs have been on the market for more than a decade and are approved for depression in more than 50 countries.

Savella Dosage:

The recommended dosage of Savella is 50 mg twice a day. It's typical to start at a smaller dosage and gradually work up to the full amount.

Savella Side Effects:

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

Sources:

Gendreau RM, et al. Journal of rheumatology. 2005 Oct;32(10):1975-85. Efficacy of milnacipran in patients with fibromyalgia.

Vitton O, et al. Human psychopharmacology. 2004 Oct;19 Suppl 1:S27-35. A couble-blind placebo-controlled trial of milnacipran in the treatment of fibromyalgia.

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