Savella for Fibromyalgia

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Savella (milnacipran HCl) is a medication manufactured by Forest Pharmaceuticals, Inc. and was approved by the U.S. Food and Drug Administration (FDA) in January 2009 to treat the pain associated with fibromyalgia, as well as improve overall functioning in fibromyalgia patients. Savella belongs to a class of drugs known as selective serotonin and norepinephrine reuptake inhibitors (SNRIs). These types of drugs work by regulating the amounts of the neurotransmitters serotonin and norepinephrine in the brain, both of which are believed to be involved in the transmission of pain signaling within the body.

Savella is taken orally in tablet form, usually twice per day. It is available in the following strengths: 12.5 mg, 25 mg, 50 mg, and 100 mg. The recommended dose of Savella is 100 mg/day, divided into two 50 mg doses; however, the dose may be increased up to 200 mg/day based on individual patient responses. It should be taken around the same time every day, with or without food. Savella will usually be dosed at a low level, and the dose gradually increased during the first week of treatment. Although some individuals experience pain relief as early as one week after the start of treatment with Savella, it may take several weeks for patients to feel the full effects. It is also important to understand that Savella can help to control many of the symptoms associated with fibromyalgia, however it is not a cure.

The most common side effect of Savella is nausea, and the risk of this can be minimized by taking Savella with food. Other common side effects include dizziness, headache, blurred vision, decreased sexual desire or ability, constipation, insomnia, hot flashes, excess sweating, vomiting, heart palpitations, increased heart rate, dry mouth, and high blood pressure. Savella has not been shown to have any impact (positive or negative) on body weight. Some side effects can be serious and warrant immediate contact with the treating physician. These include hallucinations, confusion, difficulty concentrating, weakness, unsteady gait, seizures, decreased speed of breathing, rash, yellowing of the skin or eyes, flu-like symptoms, bloody stools or vomit, unexplained bleeding or bruising (including nosebleeds), and tiny red spots under the skin. Individuals who discontinue use of Savella abruptly may experience withdrawal symptoms, which include mood changes, irritability, agitation, dizziness, numbness or tingling in the lower extremities, confusion, headache, fatigue, sleeping difficulties, ringing in the ears, or seizures. Therefore, it is important to decrease the dose gradually over a period of time when discontinuing use of Savella.

Savella is not approved for use in treating depression, however it works in the body in the same manner that other SNRI antidepressants do. Therefore, it is important to know that antidepressants in the SNRI class have the potential to increase suicidal thoughts in children, teenagers, and young adults. As a result, Savella is not approved for use by anyone under the age of 18. Furthermore, anyone taking Savella – regardless of age – should watch for new or worsening psychological symptoms, atypical changes in behavior, suicidal thoughts, increased anxiety, agitation, panic attacks, difficulty sleeping, irritability or aggression, or extreme hyperactivity. Those who experience any of these symptoms after starting treatment with Savella or after any increase in dose should contact their physician immediately.

Savella has the potential to interact negatively with a number of medications. Savella should not be taken by individuals who are currently taking, or have recently taken, drugs known as monoamine oxidase inhibitors (MAOIs). Examples of MAOIs include Marplan, Nardil, and Parnate. Caution should also be used when taking Savella along with other SNRIs, certain migraine and headache medications known as triptans, or those taking the drug tryptophan. In addition, Savella should also be used cautiously when concurrently taking non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, or blood thinning medications such as warfarin (Coumadin).

Individuals with narrow-angle glaucoma (increased pressure in the eye) should not take Savella, nor should individuals with any of the following conditions or symptoms: high blood pressure, heart disease, abnormal heart rhythm, increased heart rate, kidney problems, urinary difficulties, current or prior history of manic episodes, seizure disorders, and/or bleeding disorders.

Overview of Savella Research

The safety and efficacy of using Savella for the treatment of fibromyalgia symptoms was established in four randomized, double-blind, placebo-controlled trials (the “gold standard” of research design for studies investigating the effectiveness of a treatment) (Clauw et al., 2008; Mease et al., 2009; Arnold et al., 2010; Branco et al., 2010). These trials also formed the basis on which the FDA granted their approval of Savella. In total, over 4,000 individuals were studied, all of whom met the American College of Rheumatology (ACR) criteria for the diagnosis of fibromyalgia, and 35% of whom also had a history of depression. Overall, more patients who took Savella experienced a simultaneous reduction of at least 30% in their pain when compared to those who took placebo. In addition, those who took Savella also self-assessed their overall functioning much higher than their counterparts who were treated with placebo. Additional findings showed that treatment at both 100 mg/day and 200 mg/day levels were effective and well-tolerated, however the 200 mg/day dose of Savella was no more beneficial to patients than the 100 mg/day.

Since its approval by the FDA, research has continued to investigate the safety and efficacy of Savella as a fibromyalgia treatment, and results remain positive. A recent follow-up study by Branco et al. (2011) demonstrated that treatment with Savella at a dose of 100 mg/day, 150 mg/day, or 200 mg/day over a one-year period resulted in safe and lasting therapeutic benefits for fibromyalgia pain and overall functioning. Additionally, a large number of recent review articles that compare the effectiveness of various drugs commonly prescribed to treat fibromyalgia now include published studies regarding Savella in their analyses (Roskell et al., 2011; Hauser et al., 2012; Choy et al., 2011).

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References

1.        www.nlm.nih.gov/medlineplus/druginfo/meds/a609016.html  Accessed April 5, 2012.

2.        Savella Full Prescribing Information. Forest Pharmaceuticals, Inc.     Accessed April 5, 2012.

3.        Mease PJ, Clauw DJ, Gendreau RM, Rao SG, Kranzler J, Chen W, et al. The efficacy and safety of milnacipran for the treatment of fibromyalgia. A randomized, double-blind, placebo-controlled trial [published correction appears in J Rheumatol. 2009;36:661]. J Rheumatol. 2009;36:398-409.

4.       Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial [published correction appears in Clin

5.        Ther. 2009;31:446]. Clin Ther. 2008;11:1988-2004.

6.        Branco JC, Zachrisson O, Perrot S, Mainguy Y, on behalf of the Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol.

2010;37:851-859.

7.     Branco JC, Cherin, P, Montagne A, Bouroubi A; Multinational Coordinator Study Group. Longterm therapeutic response to milnacipran treatment for fibromyalgia. A European 1-year extension study following a 3-month study. J Rheumatol. 2011;38(7):403-412.

8.     Roskell NS, Beard SM, Zhao Y, Le TK. A meta-analysis of pain response in the treatment of fibromyalgia. Pain Pract. 2011;11(6):516-527.

9.   Hauser W, Wolfe F, Tolle T, Uceyler N, Sommer C. The role of antidepressants in the management of fibromyalgia syndrome: a systematic review and meta-analysis. CNS Drugs. 2012;26(4):297-307.

10.   Choy E, Marshall D, Gabriel ZL, Mitchell SA, Gylee E, Dakin HA. A systematic review and mixed treatment comparison of the efficacy of pharmacological treatments for fibromyalgia. Semin Arthritis Rheum. 2011;41(3):335-345.

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