WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older
[see Warnings and Precautions ].
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber
[see Warnings and Precautions].
FETZIMA is not approved for use in pediatric patients
[see Use in Specific Populations].
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FETZIMA SUMMARY
The active ingredient of FETZIMA is levomilnacipran, which is a selective serotonin and norepinephrine reuptake inhibitor (SNRI).
FETZIMA, a serotonin and norepinephrine reuptake inhibitor (SNRI) is indicated for the treatment of major depressive disorder (MDD). The efficacy of FETZIMA was established in three 8-week, randomized, double-blind, placebo-controlled studies in adult patients with a diagnosis of MDD [see
Clinical Studies (14)].
Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.
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NEWS HIGHLIGHTS
Published Studies Related to Fetzima (Levomilnacipran)
Efficacy of levomilnacipran extended-release in improving functional impairment
associated with major depressive disorder: pooled analyses of five double-blind,
placebo-controlled trials. [2014]
Major depressive disorder (MDD) is characterized by increased rates of impaired
function and disability. During antidepressant treatment, functional improvement
often lags behind symptomatic resolution, and residual impairment is associated
with an increased risk for relapse... Similarly, functional impairment was significantly improved and higher functional
and combined response and remission rates were achieved with levomilnacipran ER
compared with placebo regardless of the baseline level of functional impairment.
Clinical Trials Related to Fetzima (Levomilnacipran)
The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia [Completed]
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.
Milnacipran (Savella) in Irritable Bowel Syndrome (IBS) [Terminated]
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.
Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis [Completed]
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.
A Multicenter, Relapse Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder [Recruiting]
This study evaluates the efficacy, safety and tolerability of levomilnacipran
extended-release (ER) compared with placebo in the prevention of depression relapse (MDD).
Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia [Completed]
The objective of this study is to evaluate the safety, tolerability and efficacy of
milnacipran in patients with an inadequate response to duloxetine for the treatment of
fibromyalgia.
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Page last updated: 2015-08-10
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