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WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
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 Cymbalta or any other antidepressant 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 antidepressant therapy 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. Cymbalta is not approved for use in pediatric patients. [see Warnings and Precautions (5.1), Use in Specific Populations (8.4), and Information for Patients (17.2).]
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CYMBALTA SUMMARY
Cymbalta® (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration.
Cymbalta is indicated for the treatment of major depressive disorder (MDD).
The efficacy of Cymbalta has been established in 8- and 9-week placebo-controlled trials of outpatients who met DSM-IV diagnostic criteria for major depressive disorder ( see CLINICAL STUDIES).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
The effectiveness of Cymbalta in hospitalized patients with major depressive disorder has not been studied.
The effectiveness of Cymbalta in long-term use for major depressive disorder, that is, for more than 9 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use Cymbalta for extended periods should periodically evaluate the long-term usefulness of the drug for the individual patient.
Cymbalta is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy ( see CLINICAL STUDIES).
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NEWS HIGHLIGHTS
Published Studies Related to Cymbalta (Duloxetine)
Duloxetine added to oral nonsteroidal anti-inflammatory drugs for treatment of knee pain due to osteoarthritis: results of a randomized, double-blind, placebo-controlled trial. [2011.12]
Abstract Objective: To determine the efficacy, tolerability, and safety of duloxetine when added to oral nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with osteoarthritis (OA) of the knee with pain of moderate or greater severity. Research design and methods: This was a 10-week randomized, double-blind, flexible-dose (duloxetine 60/120 mg/day), placebo-controlled trial that enrolled adult outpatients who had persistent moderate pain (>/=4 on a 0-10 numerical rating scale) due to OA of the knee, despite, per protocol, having received optimized oral NSAID therapy (specific drug, dose, and frequency at investigator discretion).
Duloxetine as adjunctive treatment to clozapine in patients with schizophrenia: a randomized, placebo-controlled trial. [2011.11]
Antidepressant drugs have often been used as an augmentation strategy for those patients who have demonstrated a suboptimal response to clozapine. The present 16-week double-blind, randomized, placebo-controlled trial study aimed to explore the efficacy and tolerability of duloxetine add-on pharmacotherapy on clinical symptomatology and executive cognitive functioning in a sample of patients with treatment-resistant schizophrenia receiving clozapine.
A randomized placebo-controlled trial of duloxetine in patients with major depressive disorder and associated painful physical symptoms. [2011.10]
OBJECTIVE: Painful physical symptoms are common in patients with major depressive disorder (MDD) and may predict poorer treatment outcomes. Duloxetine has demonstrated efficacy in treating both MDD and certain other painful conditions. This randomized, double-blind clinical trial assessed the effects of duloxetine in patients with both MDD and MDD-associated physical pain... CONCLUSIONS: These results support the efficacy and tolerability of duloxetine in the treatment of depression and associated painful physical symptoms in patients with MDD and at least moderate MDD-associated pain.
Efficacy and safety of duloxetine 60 mg and 120 mg daily in patients hospitalized for severe depression: a double-blind randomized trial. [2011.08]
CONCLUSIONS: Duloxetine 60-mg and 120-mg doses were equally effective and demonstrated no significant differences in treating severe depressive symptoms in hospitalized patients. The safety and tolerability profile of duloxetine in both dosages did not differ and was similar to those reported in previous duloxetine studies. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00422162. (c) Copyright 2011 Physicians Postgraduate Press, Inc.
Duloxetine, pregabalin, and duloxetine plus gabapentin for diabetic peripheral neuropathic pain management in patients with inadequate pain response to gabapentin: an open-label, randomized, noninferiority comparison. [2011.07]
OBJECTIVE: To determine whether duloxetine is noninferior to (as good as) pregabalin in the treatment of pain associated with diabetic peripheral neuropathy... CONCLUSION: Duloxetine was noninferior to pregabalin for the treatment of pain in patients with diabetic peripheral neuropathy who had an inadequate pain response to gabapentin. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00385671.
Clinical Trials Related to Cymbalta (Duloxetine)
Duloxetine Versus Duloxetine Plus Non-Drug Therapy for Depression [Completed]
The primary purpose of this study is to determine if duloxetine plus non-drug intervention is
more effective than duloxetine alone in patients with depression.
The Cymbalta Pregnancy Registry [Recruiting]
The Cymbalta Pregnancy Registry is a U. S. based Registry designed to monitor women who are
exposed to Cymbalta (duloxetine) during pregnancy. This is an observational,
exposure-registration and follow-up registry.
Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus Erythematosus [Recruiting]
The purpose of this study is to determine whether Duloxetine (cymbalta) can reduce pain
severity in patient with Systemic Lupus Erythematosus.
Duloxetine for Chronic Depression: a Double-blind Study [Recruiting]
The investigators are studying a new antidepressant medicine, duloxetine, for the treatment
of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved
by the FDA for the treatment of major depression. The investigators are testing whether
this medicine is also effective for adults with chronic depression (dysthymic disorder or
dysthymia).
Chronic depression, lasting two or more years, often causes significant suffering and
impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase
during which half of the participants will take the new medication and half will take a
placebo (an inactive look-alike pill). After the Initial Phase, a 12-week Continuation
Phase will begin, during which all subjects can be treated with an FDA-approved
antidepressant medication.
Eligible subjects may also receive MRI scans, to help the investigators understand how
antidepressants work in treating depression.
Effects of Gastric Bypass on Blood Levels of Duloxetine [Recruiting]
This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine
between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control
subjects matched for body mass index (BMI), age and gender.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 42 ratings/reviews, Cymbalta has an overall score of 6.81. The effectiveness score is 7.62 and the side effect score is 7.19. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Cymbalta review by 55 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | fybromyalgia |
| Dosage & duration: | | 120mg taken once a day for the period of one year |
| Other conditions: | | none |
| Other drugs taken: | | synthroid, allegra, topamax, and Meloxicam | | |
Reported Results |
| Benefits: | | for severe pain and acheness |
| Side effects: | | none |
| Comments: | | I had severe pain from stiffness, achyness, nerve pain in the muscles in my whole body. In the morning it would take me ten minutes to get from my bed to the bathroom and I would be crying all the way because of the pain. Cymbalta is a miracle drug. When added to my other medications for pain it made all the difference in the world and I was able to function pretty normal. Thank God! |
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| | Cymbalta review by 40 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | fibromyalgia |
| Dosage & duration: | | 40 mg taken once daily for the period of three months |
| Other conditions: | | undifferentiated connective tissue disease |
| Other drugs taken: | | prednisone, leflunomide | | |
Reported Results |
| Benefits: | | Considerable reduction in muscle pain and increased energy |
| Side effects: | | panic attacks for the first few weeks, followed by mild tachycardia, moderate diarrhea, mild tinnitus |
| Comments: | | Cymbalta was started at 20 mg for two weeks, then increased to 40 mg. Dropped again to 20 mg after about a month in hopes of reducing side effects, but 40 mg turned out to be the effective does. |
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| | Cymbalta review by 26 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | depression/anxiety |
| Dosage & duration: | | 60mg taken once a day for the period of 3 days |
| Other conditions: | | n/a |
| Other drugs taken: | | n/a | | |
Reported Results |
| Benefits: | | No treatment benefits |
| Side effects: | | Confusion, memory loss,blurred vision,extreamly hot,chills,dizzy,shaking,out of body experience. |
| Comments: | | I took 60mg sunday evening...everything was fine that night. Monday do not remeber what I cooked for diner lunch and I was careing for my two small children. Monday night took my dose again.....I dont remeber doing this but my medication was counted for. Tuesday morning I was severly sleepy, dizzy and felt like I was in space all day. Tuesday night I took my regular 60 mg does and with in 1 hr I was extremly stoned...I was confusd, dizzy extreme heat sensation running threw my feet,neck and arms. I got chill and goose bumps in between. I habe high anxiety. Tingly feeling runing up and down my legs. Felt like and out of body experience because I was so stoned. Withdrall from only 3 days of meds is very uncomfortable....migraine Cymbalta should be off the market. People should be more informed about the side effects and withdral of this drug. |
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Page last updated: 2011-12-09
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