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Fluvoxamine (Fluvoxamine Maleate) - Summary

 

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Suicidality in Children and Adolescents

Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Fluvoxamine Maleate or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be 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. Fluvoxamine is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings and Precautions: Pediatric Use.)

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.

 

FLUVOXAMINE SUMMARY

Fluvoxamine Maleate
Tablets
25 mg, 50 mg and 100 mg

Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to a new chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine.

Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD), as defined in the DSM-III-R. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.

The efficacy of Fluvoxamine Maleate Tablets was established in three 10-week trials with obsessive compulsive outpatients with the diagnosis of Obsessive Compulsive Disorder as defined in DSM-III-R. (See Clinical Trials under CLINICAL PHARMACOLOGY.)

Obsessive Compulsive Disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego- dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.

The effectiveness of Fluvoxamine Maleate Tablets for long-term use, i.e., for more than 10 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use Fluvoxamine Maleate Tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. (See DOSAGE AND ADMINISTRATION.)

FLUVOXAMINE NEWS HIGHLIGHTS

Published Studies Related to Fluvoxamine

Fluvoxamine treatment of generalized social anxiety disorder in Japan: a randomized double-blind, placebo-controlled study. [2007.04]

Effect of fluvoxamine and erythromycin on the pharmacokinetics of oral lidocaine. [2006.08]

Effects of caffeine on the kinetics of fluvoxamine and its major metabolite in plasma after a single oral dose of the drug. [2006.06]

[A double-blind controlled study of the efficacy and acceptability of tianeptine in comparison with fluvoxamine in the treatment of depressed alcoholic patients] [2006.05]

Liver dysfunction markedly decreases the inhibition of cytochrome P450 1A2-mediated theophylline metabolism by fluvoxamine. [2006.05]

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Clinical Trials Related to Fluvoxamine

Fluvoxamine and Sertraline in Childhood Autism - Does SSRI Therapy Improve Behaviour and/or Mood? [Completed]

Interaction Between Fluvoxamine and Sildenafil [Completed]

Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-Marketing Clinical Study in Children and Adolescents [Recruiting]

Fluvoxamine Maleate in the Treatment of Depression/Depressive State: A Post-Marketing Clinical Study in Children and Adolescents [Recruiting]

Genetic Expression in Schizophrenics Treated With SSRI Augmentation: Relationship to Clinical and Cognitive Function [Not yet recruiting]

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Page last updated: 2007-05-03

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