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 Maleate Tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See WARNINGS AND PRECAUTIONS-Clinical Worsening and Suicide Risk [ 5.1 ].)
|
|
FLUVOXAMINE SUMMARY
Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones.
Obsessive-Compulsive Disorder
Fluvoxamine Maleate Tablets, USP are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
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 efficacy of Fluvoxamine Maleate Tablets, USP was established in three trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8-17). (See CLINICAL STUDIES [ 14 ].)
|
|
NEWS HIGHLIGHTS
Published Studies Related to Fluvoxamine
Extended-release fluvoxamine and improvements in quality of life in patients with obsessive-compulsive disorder. [2010.07] OBJECTIVE: We hypothesized that subjects with obsessive-compulsive disorder (OCD) who received extended-release fluvoxamine (fluvoxamine ER) in a 12-week placebo-controlled trial would exhibit improvements in psychosocial domains of health-related quality of life (HRQOL) and that additional improvements would occur after a 40-week open-label extension trial. We also hypothesized that greater OCD symptom improvement in the first 12 weeks of treatment would be associated with greater HRQOL improvement after 52 weeks of treatment... CONCLUSION: Improvement in Yale-Brown Obsessive-Compulsive Scale severity scores during treatment with fluvoxamine ER was associated with improvements in psychosocial aspects of HRQOL that increased over an extended period of treatment. Copyright 2010 Elsevier Inc. All rights reserved.
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.
Clinical Trials Related to Fluvoxamine
The Effect of Fluvoxamine on Polysonogram in Depressed Patients With Insomnia [Recruiting]
Major depressive disorder is associated with several sleep Polysomnograph (PSG) findings:
(1) impaired sleep continuity; (2) non-REM (NREM) changes; and (3) enhanced rapid eye
movement (REM) sleep. The first two patterns are common in other psychiatric disorders,
while the REM pattern is very characteristic in depression, so the phase-advance theory was
accepted by most of psychiatrists. Many researchers have focused on the biological rhythm to
investigate the etiological and pathophysiology of depression, and they think depression can
be cured if its sleep abnormality is ameliorated.
It is well known that most of antidepressants treat depression through 5-hydroxytryptamine
(5-HT) neurons. 5-HT also affects the regulation of the sleep-wake cycle and the sleep
microarchitecture. Many all-night PSG studies have shown tricyclic antidepressants can
ameliorate the sleep architecture abnormality in depression by producing rapid suppression
of REM sleep.
Compared to TCAs, SSRIs are generally less sedating because of its high selectivity for
serotonin receptors. On the other hand, it is known that, although all of SSRIs mainly
increase the extracellular serotonin level by inhibiting serotonin transport in the
presynaptic neuron, each SSRI has its unique pharmacological characteristics. For example,
it was reported by accumulating researches that the serum melatonin level increased markedly
after ingestion of fluvoxamine. The mechanism behind this effect is unknown, but one
possibility is increased melatonin synthesis, caused by effects on serotonin, which is a
melatonin precursor. Another possibility is that fluvoxamine inhibits the metabolism of
melatonin in the liver.
Thus, the property of fluvoxamine to increase serum melatonin level, or even recover the
circadian rhythm of melatonin in depressed patients, might improve the clinical outcome by
improving the sleep quality and quantity. By now, the changes of sleep architecture in
fluvoxamine treatment were assessed by only three clinical trials, and their results were
contradictive. This discrepancy might be due to the small sample size and different study
design, such as clinical trial duration. Moreover, two of three researches applied
home-based PSG assessment, which might have distorted the results of sleep architecture to
some extent. Thus, the effects of fluvoxamine on sleep architecture need to be clarified by
more clinical trials with standard PSG assessment.
Study to Evaluate the Effect of Multiple-dose of Fluvoxamine on the Plasma Concentration of Quetiapine (FK949E) in Healthy Male Volunteers [Completed]
The objective of the study was to assess the effect of multiple-dose fluvoxamine on the
pharmacokinetics of quetiapine (FK949E) in healthy adult male subjects. The safety of FK949E
in the population was also evaluated.
Safety and Pharmacokinetics of ASA404 When Given Together With Fluvoxamine, a Selective Serotonin Receptor Reuptake Inhibitor and CYP1A2 Inhibitor [Terminated]
This trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an
inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The
purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and
ASA404. The purpose of the Extension Phase is to provide continued treatment for those
patients that have not progressed during the Core Phase and to collect safety data on ASA404
when given in combination with paclitaxel, docetaxel or the paclitaxel plus carboplatin
chemotherapy regimen.
Treatment Strategy for Refractory Schizophrenia: Drug Interaction Between Clozapine and Fluvoxamine [Completed]
Clozapine has been virtually the only psychopharmacological choice in patients with
schizophrenia who either did not response to typical neuroleptics or experienced severe
extrapyramidal side effects and consequently did not tolerate this medication. There are
patients who do not respond to clozapine, and the need to treat these severely ill patients
frequently compels clinicians to adopt therapeutic innovations that lack a sound empirical
basis. One strategy is the combination of various other somatic treatments with clozapine.
Recently, the investigators conduct a preliminary open trial to evaluate the safety and
efficacy of fluvoxamine coadministration with clozapine in refractory schizophrenic
patients. The combined treatment is well tolerated, and clinical improvement is observed in
our patients. And the concomitant fluvoxamine could attenuate the clozapine-induced weight
gain and metabolic disturbance. However, the effects of fluvoxamine on the safety and
therapeutic efficacy of clozapine need to be further clarified in double-blind study.
Impact of Omeprazole and Fluvoxamine on Platelet Response to Clopidogrel [Completed]
Clopidogrel is a platelets inhibitor that is widely used particularly during and after acute
coronary events and coronary interventions. Several studies have shown that some patients
are resistant to clopidogrel. The resistance mechanism is not entirely clear yet, but at
least in part it is related to interactions between medications.
Omeprazole is a member in the family of gastric proton pump inhibitor (PPI) that are widely
used in patients who receive combination of aspirin and clopidogrel in order to protect the
stomach lining and prevent GI bleeding. Data from studies on platelet aggregation indicate
that treatment with omeprazole may cause partial resistance to clopidogrel and increase risk
for recurrent cardiovascular events in patients after coronary interventions. Recently the
FDA published struck to avoid cross clopidogrel and omeprazole treatment for fear of
reduction efficiency. Nevertheless there are several studies that do not support increased
risk of cardiovascular events among patients taking omeprazole and clopidogrel, as the
COGENT trial which is the single prospective controlled study that assessed the clinical
implication of this drugs interaction.
The accepted Mechanism of interaction between omeprazole and clopidogrel is disturbance to
create clopidogrel active metabolite through CYP2C19 inhibition by omeprazole. fluvoxamine -
is a member in SSRIs family and a potent inhibitor of the CYP2C19. In vivo studies compared
the degree of decomposition proguanil (a CYP2C19 indicator) by fluvoxamine and omeprazole
found constant inhibition- Ki = 10 Micromol / L for of Omeprazole versus constant
inhibition- Ki = 0. 69 Micromol / L for fluvoxamine. This indicates a more potent inhibition
of CYP2C19 in vivo of fluvoxamine compared to omeprazole. It is important to note that so
far there is no date in literature studies demonstrates that there is any interaction
between fluvoxamine and other CYP2C19 inhibitors and Clopidogrel.
Research goals:
- To assess the impact of fluvoxamine and omeprazole on platelet reactivity in healthy
individuals treated with clopidogrel.
- To verify weather the mechanism of omeprazole-clopidogrel interaction is related to
CYP2C19 inhibition.
Study design:
Randomized blinded placebo-controlled crossover trial on healthy volunteers. The response to
clopidogrel will be assessed using two methods in subjects receiving clopidogrel and one of
the study drugs: fluvoxamine, omeprazole or placebo.
|
PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 4 ratings/reviews, Fluvoxamine has an overall score of 8.50. The effectiveness score is 8 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| 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: 2010-10-05
|