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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 HIGHLIGHTSMedia Articles Related to Cymbalta (Duloxetine)
Cymbalta for Fibromyalgia Treatment
Source: MedicineNet Fibromyalgia Specialty [2009.08.07]
Title: Cymbalta for Fibromyalgia Treatment
Category: Health Facts
Created: 8/7/2009
Last Editorial Review: 8/7/2009
Published Studies Related to Cymbalta (Duloxetine)
Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: A 13-week, randomized, placebo-controlled trial. [2009.07.20]
Pain is a common cause of disability in osteoarthritis... Adverse-event rates did not differ significantly between treatment groups (49.5% for duloxetine 60-120mg/day, and 40.8% for placebo).
A 1-year safety and efficacy study of duloxetine in patients with fibromyalgia. [2009.06]
OBJECTIVES: Evaluate the efficacy and safety of duloxetine at doses up to 120 mg once daily in patients with fibromyalgia. METHODS: This was a phase 3, 60-week study, which included an 8-week open-label period followed by a 52-week, randomized, double-blind period.DISCUSSION: The profile of duloxetine for the long-term treatment of fibromyalgia was consistent with that seen in other indications for which the drug is currently marketed.
Variation in catechol-O-methyltransferase is associated with duloxetine response in a clinical trial for major depressive disorder. [2009.05.01]
BACKGROUND: The study objective was to evaluate variations in genes implicated in antidepressant mechanism of action for association with response to duloxetine treatment in major depressive disorder (MDD)... CONCLUSIONS: Single nucleotide polymorphisms in COMT were associated with symptom change in duloxetine-treated patients with MDD. If replicated, the magnitude of the COMT genotype effect is of clinical relevance.
Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial. [2009.05]
CONCLUSIONS: Treatment with duloxetine was associated with a longer time to depressive recurrence and a significantly lower recurrence rate compared with placebo. TRIALS REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00105989. Copyright 2009 Physicians Postgraduate Press, Inc.
Pharmacokinetics of duloxetine hydrochloride enteric-coated tablets in healthy Chinese volunteers: a randomized, open-label, single- and multiple-dose study. [2009.05]
BACKGROUND: Duloxetine hydrochloride is a balanced selective serotonin and norepinephrine reuptake inhibitor. Despite being widely used for the treatment of major depressive disorder in China, little information is available on the pharmacokinetic (PK) properties of duloxetine in Chinese subjects. OBJECTIVES: This study was designed to determine the concentration of duloxetine in human plasma and to compare the PK properties of duloxetine after administration of single and multiple doses of duloxetine in healthy Chinese volunteers... CONCLUSIONS: In these healthy Chinese subjects, AUC and Cmax increased proportionally with the dose, whereas t(1/2) was independent of the dose. Linear PK properties were found at doses of 30 to 90 mg. No statistically significant differences were observed between the PK parameters for the subjects in the multiple-dose phase (t(1/2), CL, V(d)) and those for subjects in the single-dose phase. The AUC and C(max) were greater after administration of multiple doses than after administration of a single dose, suggesting du-loxetine accumulation with multiple-dose administration of 30 mg.
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.
An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache [Completed]
Background: Although major depression and chronic headache are strongly associated, there is
insufficient evidence on the use of antidepressants for this specific comorbidity. This trial
aimed to investigate the efficiency and tolerability of duloxetine for this indication.
Methods: Thirty outpatients of our clinic, with DSM-IV major depression and concurrent
primary chronic headache (chronic migraine, chronic tension-type headache or both), 18-55
years, were recruited from April 2006 to March 2007, if they scored >21 on the
Montgomery-Äsberg Depression Scale (MADRS) and had no other significant clinical condition.
Subjects received duloxetine 60 mg/day for 8 weeks. MADRS scores and a visual analog pain
scale (VAS) were the co-primary outcome measures. WHO quality of life scale (WHOQoL BREF)
scores and headache days/week were secondary outcome measures. Conclusion: In this preliminary
open trial, duloxetine 60 mg/day was effective, fast acting and well tolerated for the
treatment of comorbid major depression and chronic headache.
Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence [Completed]
The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle
training with that of placebo in patients with moderate to severe stress urinary
incontinence
Study of Duloxetine in Elderly Patients With Major Depressive Disorder [Completed]
A study of the safety and efficacy of duloxetine in elderly patients (greater than 65 years
old) with major depressive disorder
Duloxetine - Warfarin Pharmacodynamic Study [Completed]
To evaluate the blood clotting effects of multiple doses of warfarin at steady state when
taken at the same time as multiple doses of duloxetine as measured by changes in the
International Normalised Ratio.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 27 ratings/reviews, Cymbalta has an overall score of 6.93. The effectiveness score is 7.78 and the side effect score is 7.56. 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: | | Marginally Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Fibromyalgia and depression |
| Dosage & duration: | | 90 mg daily taken daily for the period of 3 months |
| Other conditions: | | Hypothyroidism |
| Other drugs taken: | | Synthroid | | |
Reported Results |
| Benefits: | | I only noticed a very small benefit from taking Cymbalta for my muscle pain. |
| Side effects: | | Cymbalta elevated my liver enzymes acutely after only being on the drug for a few months. The doctor then titrated me off of it and it took three months after I stopped Cymbalta before my liver went back to normal. Just be sure to have your liver enzymes checked regularly if you are on this drug. |
| Comments: | | I was on 90 mg daily, one dose of 60 mg and one dose of 30 mg. It was prescribed to me for fibromyalgia and depression, however, I did not notice much improvement on this drug but I was not on it for a real long time either so it may just take longer to notice benefit but it definitely affected my liver. My mom also has the same problem with Cymbalta and her liver enzymes. |
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Page last updated: 2009-10-20
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