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WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients [ see Warnings and Precautions (5.1), Use in Specific Populations (8.4) ]
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SAVELLA SUMMARY
Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin.
Savella is indicated for the management of fibromyalgia.
Savella is not approved for use in pediatric patients [ see Use in Specific Populations (8.4) ].
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NEWS HIGHLIGHTSMedia Articles Related to Savella (Milnacipran)
FDA OKs Opioid for Diabetic Pain
Source: MedPage Today Product Alert [2012.08.29]
WASHINGTON -- The FDA has approved the first opioid painkiller for neuropathic pain associated with diabetic peripheral neuropathy, according to the drug maker.
Published Studies Related to Savella (Milnacipran)
Prevention of poststroke depression with milnacipran in patients with acute ischemic stroke: a double-blind randomized placebo-controlled trial. [2011.09]
Poststroke depression (PSD) is one of the most frequent neuropsychiatric consequences of stroke. It has been shown to be associated with both impaired recovery and increased mortality... In conclusion, milnacipran could prevent the development of depression in the first year following a stroke and is safe to use without significant adverse effects in stroke patients.
The dubious effect of milnacipran for the treatment of burning mouth syndrome. [2011.07]
OBJECTIVE: Burning mouth syndrome (BMS) is a condition accompanied by oral burning symptoms, including glossal pain (glossodynia) without a detectable cause. Although BMS is a chronic-pain syndrome, only one self-controlled pilot study and some case reports have reported that milnacipran is effective for the treatment of chronic pain, including that caused by BMS. However, these papers assessed only pain, and the dosage of prescribed milnacipran varied from 30 to 150 mg/d in each patient. In this study, the dosage of prescribed milnacipran was set at 60 mg/d for 12 weeks for all patients, and depression and quality of life (QOL) were assessed in addition to pain... CONCLUSIONS: A randomized, double-blind, placebo-controlled multi-institution trial of milnacipran will be essential to determine its effectiveness for the treatment of BMS.
The dubious effect of milnacipran for the treatment of burning mouth syndrome. [2011]
(QOL) were assessed in addition to pain... CONCLUSIONS: A randomized, double-blind, placebo-controlled multi-institution
Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. [2010.09]
OBJECTIVE: To assess the efficacy and safety of milnacipran at a dosage of 100 mg/day (50 mg twice daily) for monotherapy treatment of fibromyalgia... CONCLUSION: Milnacipran administered at a dosage of 100 mg/day improved pain, global status, fatigue, and physical and mental function in patients with fibromyalgia.
Contributions of change in clinical status parameters to Patient Global Impression of Change (PGIC) scores among persons with fibromyalgia treated with milnacipran. [2010.05]
Clinical trials on the treatment of pain syndromes have adopted Patient Global Impression of Change (PGIC) as a primary outcome. However, little is known about how change in clinical status influences these ratings...
Clinical Trials Related to Savella (Milnacipran)
Milnacipran (Savella) in Irritable Bowel Syndrome (IBS) [Recruiting]
Purpose: The investigators are proposing to examine the use of Savella® (Milnacipran) for
treating irritable bowel syndrome (IBS) in women.
Participants: Eligible participants will meet the Rome III diagnostic criteria for IBS.
Procedures: This study will observe patients treated with Savella® as well as patients
treated with a placebo (pill with no active drug). The investigators will monitor and
compare several patient and symptom related outcomes, as well as evaluate health related
quality of life, psychological distress and related psychosocial measures to determine if
the addition of Savella�® improves clinical pain response as well as secondary outcomes
including quality of life.
The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia [Recruiting]
Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most
of the patients with fibromyalgia complain of either non-restorative sleep or complaints of
disturbed sleep due to pain. The proposed study is aimed at examining the effects of
milnacipran on sleep disturbance in patients with fibromyalgia. The study is randomized,
double-blind, placebo controlled, two way crossover PSG study to explore the effects of
milnacipran on sleep disturbance. Patients will receive either milnacipran 50 mg BID or
matching placebo.
A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia [Recruiting]
Fibromyalgia is a condition that includes pain, tenderness, stiff muscle, and fatigue.
Researchers want to find out if "a drug" called milnacipran can help people with
fibromyalgia. milnacipran (Savella) is approved by the FDA for the management of
fibromyalgia. In this study, milnacipran will be given to find out more about how it affects
pain and thinking in people with fibromyalgia.
Pain Assessment and Quality of Life in Back Pain Patients: Role of Milnacipran [Recruiting]
1. To show that patients with greater pain sensitivity will show greater improvement in
their symptoms (self-reported pain intensity, mood, sleep, and quality of life) than
those with lower pain sensitivity, based on QST, after taking milnacipran.
2. To compare outcome differences (pain intensity, mood, activity interference, sleep, and
side effects) with those patients who are either taking or not taking opioids for their
pain 10 weeks after being prescribed milnacipran.
3. To show that patients who are older, male, with more medical comorbidities, greater
disability, and longer pain duration will report less improvement (pain, mood, sleep,
health-related quality of life) and treatment satisfaction while taking milnacipran
compared with others without such characteristics.
Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis [Recruiting]
The purpose of this study is to determine whether milnacipran reduces widespread, non-joint
pain in patients with rheumatoid arthritis (RA). The investigators will conduct a
double-blind randomized crossover trial in subjects with RA to test the hypothesis that
milnacipran improves widespread, non-joint pain. The investigators will also use data from
the trial to determine whether response to milnacipran is associated with pain-modulating
mechanisms from the central nervous system. The investigators hypothesize that response to
milnacipran will be greater among patients with impaired central pain mechanisms than among
patients with intact central pain modulating mechanisms.
Reports of Suspected Savella (Milnacipran) Side Effects
Nausea (47),
Headache (33),
Insomnia (24),
Vomiting (23),
Hyperhidrosis (22),
Pain (21),
Blood Pressure Increased (21),
Dizziness (20),
Depression (20),
Heart Rate Increased (18), more >>
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Page last updated: 2013-02-10
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