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Nefazodone (Nefazodone Hydrochloride) - Summary

 
 



BOXED WARNING

Warning

Cases of life-threatening hepatic failure have been reported in patients treated with nefazodone hydrochloride tablets. The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 to 300,000 patient-years of nefazodone hydrochloride treatment. The total patient-years is a summation of each patient’s duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc. (See WARNINGS.)

Ordinarily, treatment with nefazodone hydrochloride tablets should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.

Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.

Nefazodone hydrochloride tablets should be discontinued if clinical signs or symptoms suggest liver failure (see PRECAUTIONS, Information for Patients). Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels ≥ 3 times the upper limit of NORMAL , while on nefazodone hydrochloride tablets should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if nefazodone hydrochloride is reintroduced. Accordingly, such patients should not be considered for re-treatment.

 

NEFAZODONE SUMMARY

NEFAZODONE HYDROCHLORIDE TABLETS

(Patient Information Included)

Nefazodone hydrochloride tablets are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant.

Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first.

The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY).

A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and at least five of the following nine 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, a suicide attempt or suicidal ideation.

The efficacy of nefazodone in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label nefazodone treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use nefazodone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.


See all Nefazodone indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Nefazodone

Boys and girls who mature early are at higher risk of several adverse outcomes, including depression
Source: Anxiety / Stress News From Medical News Today [2014.11.22]
Youth who enter puberty ahead of their peers are at heightened risk of depression, although the disease develops differently in girls than in boys, a new study suggests.

Postpartum depression: citalopram benefits explained
Source: Depression News From Medical News Today [2014.11.21]
Researchers believe they have found why the commonly prescribed antidepressant drug citalopram is effective in relieving postpartum depression.

Stress and Depression Mediated by Single Brain Protein
Source: Medscape Psychiatry & Mental Health Headlines [2014.11.20]
Beta-catenin plays a central role in resilience to stress and susceptibility to depression, potentially offering novel therapeutic targets, say US scientists.
Medscape Medical News

Job authority may increase depression symptoms in women
Source: Anxiety / Stress News From Medical News Today [2014.11.20]
Women in authoritative job positions have more depression symptoms than those not in such positions, a new study finds. But for men, job authority may reduce depression symptoms.

How the brain manages stress suggests new model of depression
Source: Anxiety / Stress News From Medical News Today [2014.11.16]
Discovery of new molecular and behavioural connections may provide a foundation for the development of new treatments to combat some forms of depressionThe brain's ability to effectively deal...

more news >>

Published Studies Related to Nefazodone

Patient preference as a moderator of outcome for chronic forms of major depressive disorder treated with nefazodone, cognitive behavioral analysis system of psychotherapy, or their combination. [2009.03]
CONCLUSIONS: These results suggest that patient preference is a potent moderator of treatment response for patients with chronic forms of MDD; however, relatively low proportions of the patient sample preferred one of the monotherapies, participants were not blinded to treatment assignment, and there was no placebo group.

A preliminary trial: double-blind comparison of nefazodone, bupropion-SR, and placebo in the treatment of cannabis dependence. [2009.01]
The present study investigated the efficacy of nefazodone and bupropion-sustained release for treating cannabis dependence. A double-blind, placebo-controlled, piggy back design was employed to assess if nefazodone and bupropion-sustained release increased the probability of abstinence from cannabis and reduced the severity of cannabis dependence and cannabis withdrawal symptoms during a 13-week outpatient treatment program...

Nefazodone in the treatment of generalized social phobia: a randomized, placebo-controlled trial. [2007.02]
CONCLUSION: These findings suggest that nefazodone is not an effective agent in the treatment of GSP. These data parallel some recent findings with the use of the SSRI fluoxetine in GSP. The lack of efficacy of 2 serotonergic antidepressants in GSP suggests that serotonin reuptake inhibition may not be the only mechanism of action required for efficacy to occur in the treatment of GSP.

Chronic depression: medication (nefazodone) or psychotherapy (CBASP) is effective when the other is not. [2005.05]
CONTEXT: Although various strategies are available to manage nonresponders to an initial treatment for depression, no controlled trials address the utility of switching from an antidepressant medication to psychotherapy or vice versa. OBJECTIVE: To compare the responses of chronically depressed nonresponders to 12 weeks of treatment with either nefazodone or cognitive behavioral analysis system of psychotherapy (CBASP) who were crossed over to the alternate treatment (nefazodone, n = 79; CBASP, n = 61)... CONCLUSIONS: Among chronically depressed individuals, CBASP appears to be efficacious for nonresponders to nefazodone, and nefazodone appears to be effective for CBASP nonresponders. A switch from an antidepressant medication to psychotherapy or vice versa appears to be useful for nonresponders to the initial treatment.

Nefazodone in out-patient treatment of inhaled cocaine dependence: a randomized double-blind placebo-controlled trial. [2005.04]
AIMS: To assess the efficacy of oral nefazodone in the treatment of cocaine dependence. DESIGN: A 10-week randomized double-blind clinical trial was performed... CONCLUSIONS: These results do not support the indication of nefazodone for out-patient treatment of inhaled cocaine dependence with or without other associated drug dependence diagnoses.

more studies >>

Clinical Trials Related to Nefazodone

Nefazodone in the Treatment of Cocaine Dependence and Depression - 4 [Active, not recruiting]

Nefazodone in the Treatment of Social Phobia [Completed]
The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD).

Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10 [Completed]
The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use in depressed and non-depressed females with cocaine abuse/dependence.

Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals [Completed]
Recent research has identified the following withdrawal symptoms to be associated with abruptly stopping marijuana use: anxiety, irritability, bodily aches and pains, and difficulty sleeping. These symptoms resemble those of both depression and nicotine withdrawal, suggesting that a similar treatment drug may be useful. This study will evaluate the effectiveness of two antidepressant drugs, bupropion and nefazodone, in reducing withdrawal symptoms in marijuana dependent individuals.

Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3 [Completed]

more trials >>


Page last updated: 2014-11-22

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