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 fluvoxamine maleate tablets 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. Fluvoxamine is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See WARNINGS, Clinical Worsening and Suicide Risk, PRECAUTIONS, Information for Patients, and PRECAUTIONS, Pediatric Use .)
|
| |
FLUVOXAMINE SUMMARY
FLUVOXAMINE MALEATE TABLETS USP
Rx only
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.)
|
NEWS HIGHLIGHTS
Published Studies Related to Fluvoxamine
Pharmacokinetics and efficacy of fluvoxamine and amitriptyline in depression. [2009.05]
Although often necessary for obtaining remission following major depressive disorder, combined antidepressant treatment is frequently associated with drug interactions and enhanced adverse drug effects. We investigated pharmacokinetic interactions following combined fluvoxamine and amitriptyline treatment and their impact on therapeutic efficacy and tolerability...
Activation adverse events induced by the selective serotonin reuptake inhibitor fluvoxamine in children and adolescents. [2009.04]
OBJECTIVE: The aim of this study was to examine the prevalence of activation cluster adverse events (AC-AEs) in youths treated with the selective serotonin reuptake inhibitor (SSRI) fluvoxamine for anxiety and the relationship of AC-AEs to SSRI blood levels... CONCLUSIONS: AC-AEs were common side effects of fluvoxamine, often appeared during the first 8 weeks of treatment, and were associated with higher fluvoxamine blood levels. Close monitoring for AC-AEs, not only when initiating SSRI treatment but also throughout dose titration, is recommended for early identification of activation.
Controlled-release fluvoxamine in obsessive-compulsive disorder and social phobia. [2008.12]
Specific serotonin reuptake inhibitors are currently recommended as first-line treatments for obsessive-compulsive disorder (OCD) and social phobia or social anxiety disorder (SAD)...
[Additional treatment in chronic pain syndrome due to hip and knee arthritis with the selective serotonin reuptake inhibitor fluvoxamine (Fevarin] [2008.11]
OBJECTIVE: The aim of this study was to investigate the effectiveness and safety of the selective serotonin reuptake inhibitor fluvoxamine (Flevarin) in patients with a chronic pain syndrome due to hip and knee arthritis... CONCLUSION: Considering the good effects in combination with very few side effects, a positive cost-effectiveness relation for the usage of fluvoxamine can be stated in patients with chronic pain syndrome due to hip and knee arthritis.
Fluvoxamine treatment of generalized social anxiety disorder in Japan: a randomized double-blind, placebo-controlled study. [2007.04]
The efficacy of selective serotonin reuptake inhibitors (SSRIs) for the treatment of social anxiety disorder (SAD) has been reported in the USA and Europe. However, no clinical investigation has been done with SSRIs in Japanese patients with SAD... These results suggest that fluvoxamine is effective for the treatment of Japanese patients with GSAD.
Clinical Trials Related to Fluvoxamine
Fluvoxamine and Sertraline in Childhood Autism - Does SSRI Therapy Improve Behaviour and/or Mood? [Completed]
The purpose of this study is to determine if fluvoxamine or sertraline reduce the fequency or
severity of aggressive behaviour, obsessive symptoms, or anxiety in young children with
autism. The within-patient variability in this patient population using standard
neuropsychological instruments will also be determined and a predictor model for SSRI
responsitivity based on baseline neuropsychological testing will be developed.
Interaction Between Fluvoxamine and Sildenafil [Completed]
Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its
effect on the venous response to sodium nitroprusside.
Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-Marketing Clinical Study in Children and Adolescents [Recruiting]
This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment
of children and adolescents with obsessive-compulsive disorder
Fluvoxamine Maleate in the Treatment of Depression/Depressive State: A Post-Marketing Clinical Study in Children and Adolescents [Recruiting]
This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the
treatment of children and adolescents with depression or depressive state
Treatment for Anxiety in Children [Completed]
The purpose of this study is to see if it is effective to treat children with anxiety
disorders with fluvoxamine.
Fluvoxamine has been successfully used to treat obsessive-compulsive disorder (OCD) in adults
and children. Anxiety disorders other than OCD, such as generalized anxiety disorder, social
phobia, or separation anxiety, are very common in youth and are not always responsive to
behavioral therapies alone. These disorders may respond to fluvoxamine.
A child will be evaluated for 3 weeks before he/she is assigned randomly (like tossing a
coin) to receive either fluvoxamine or an inactive placebo for 8 weeks. After this
double-blind phase (neither the child/parents nor the doctor know which treatment is being
given), the child will have the option of continuing treatment during a 4-month open-label
extension period (both the child/parents and the doctor know which the child is receiving).
A child may be eligible for this study if he/she:
Is 6 to 17 years old and has been diagnosed with an anxiety disorder (i. e., generalized
anxiety disorder, social phobia, or separation anxiety).
|
PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Fluvoxamine has an overall score of 8. The effectiveness score is 7.33 and the side effect score is 9.33. The scores are on ten point scale: 10 - best, 1 - worst.
| | Fluvoxamine review by 51 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | ocd, bipolor disease |
| Dosage & duration: | | 300 mg taken 100 mg am, 200 mg at bedtime for the period of 7 years |
| Other conditions: | | extreme chronic dysphasia |
| Other drugs taken: | | depakote, wellbutrin | | |
Reported Results |
| Benefits: | | Stopped suicidal thoughts, stopped my constant worrying , my mind felt at peace for the first time in my life |
| Side effects: | | wt. loss at first |
| Comments: | | took about 2 weeks to work and then the results felt miraculous as the constant suicidal thoughts gradually disappeared. |
|
| | Fluvoxamine review by 44 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Ineffective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Anxiety/worry |
| Dosage & duration: | | 25 mg taken once daily for the period of 4 mos |
| Other conditions: | | Hormone changes - weaning baby at time |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | None, especially surprising since the prescription name brand Luvox had been used previously, with great results. The Luvox stopped all ruminations and obsessive worry, while the generic fluvoxamine seemed to do nothing, and did not help with sleep. |
| Side effects: | | Some vague nausea, which was not a problem with the name brand drug. |
| Comments: | | At the time of weaning my second child, I was apparently experiencing some hot flashes/night sweats and worry/ panic and tried fluvoxamine, the generic version of Luvox (which I had used previously by about four years). I had successfully used Luvox and was able to discontinue it without any side effects or symptoms of worry returning. This time only the generic was available to me so I tried it - thinking that it would be the same drug and provide similar results. It did not. I experienced nausea, and did not get any sleep benefits, although I felt that the Luvox had improved my sleep when taken at night; neither version of the drug caused any drowsiness. I did not feel any improvement in symptoms with the generic version. Perhaps my hormones needed to balance on their own, and were too intense for the fluvoxamine to modify. I hope there will be something better available if menopause eventually causes a return of symptoms.
Some generics are better than others, and individual reactions differ. It is useful to have this rating information available to access online. |
|
| | Fluvoxamine review by 44 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Anxiety/worry |
| Dosage & duration: | | 25 mg taken once daily for the period of 4 mos |
| Other conditions: | | Hormone changes - weaning baby at time |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | None, especially surprising since the prescription name brand Luvox had been used previously, with great results. The Luvox stopped all ruminations and obsessive worry, while the generic fluvoxamine seemed to do nothing, and did not help with sleep. |
| Side effects: | | Some vague nausea, which was not a problem with the name brand drug. |
| Comments: | | At the time of weaning my second child, I was apparently experiencing some hot flashes/night sweats and worry/ panic and tried fluvoxamine, the generic version of Luvox (which I had used previously by about four years). I had successfully used Luvox and was able to discontinue it without any side effects or symptoms of worry returning. This time only the generic was available to me so I tried it - thinking that it would be the same drug and provide similar results. It did not. I experienced nausea, and did not get any sleep benefits, although I felt that the Luvox had improved my sleep when taken at night; neither version of the drug caused any drowsiness. I did not feel any improvement in symptoms with the generic version. Perhaps my hormones needed to balance on their own, and were too intense for the fluvoxamine to modify. I hope there will be something better available if menopause eventually causes a return of symptoms.
Some generics are better than others, and individual reactions differ. It is useful to have this rating information available to access online. |
|
|
|
Page last updated: 2009-10-20
|
