Fluvoxamine (Fluvoxamine Maleate) - Summary

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.)

See all Fluvoxamine indications & dosage >>

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.

more studies >>

Clinical Trials Related to Fluvoxamine

Impact of Citalopharm and Fluvoxamine on Platelet Response to Clopidogrel [Not yet recruiting]
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, but at least in part it is related to interactions between medications. Clopidogrel is a pro-drug converted in vivo to its active metabolite by CYP2C19 and CYP3A in the liver. Consequently drugs that inhibit the CYP2C19 can affect the production of the active metabolite and cause "clopidogrel resistance". Therefore the FDA has recently published a "safety alert" which recommends avoiding cross treatment with clopidogrel and drugs that are expected to inhibit CYP2C19 (including omeprazole, fluvoxamine, cimetidine, fluconazole and others). Nevertheless there no clear evidence in the literature for clinical relevance of such interactions.

Selective serotonin reuptake inhibitors (SSRIs) are group of antidepressant drugs that are widely used for treatment of depression and anxiety. SSRIs are considered to be very safe with favorable side effect profile, hence many patient after coronary events who suffers from behavioral and emotional disturbances are treated with those drugs. However there are several reports that SSRIs can inhibit platelet function and increase bleeding tendency particularly in concomitant administration with aspirin. The proposed mechanism is blocking of platelets serotonin reuptake that result in platelet dysfunction.

Fluvoxamine - is a member in the SSRI family and a potent inhibitor of the CYP2C19.

Theoretically fluvoxamine should have two conflicting effects on the response to clopidogrel. Pharmacokinetically it is expected to decrease the clopidogrel responsiveness due to inhibition of CYP2C19 and reduction in the production of the active metabolite. On the other hand "pharmacodynamically" fluvoxamine may directly inhibit platelet aggregation due its effect on serotonin reuptake, thus increasing the effect of clopidogrel. Other SSRIs that do not interact with the CYP2C19 such as citalophram are expected to have only pharmocodynamic effect on platelet aggregation.

Although both clopidogrel and SSRIs are widely used in the last decade and concomitant treatment is quite common, no data is available about in influence of the interaction between those drugs on platelet function and on clinical events. The net effect of fluvoxamine and other SSRIs on platelet function in the presence of clopidogrel is not known.

The aim of the investigators study is to assess the effect of two SSRIs fluvoxamine and citalophram on platelet aggregation and to test the effect of these drugs on the laboratory response to clopidogrel, in healthy individuals.

Study design: randomized, double blinded, controlled crossover trial. Primary study end point: Change in % platelet aggregation and VASP phosphorylation after treatment with clopidogrel + fluvoxamine or clopidogrel + citalophram as compared to each drug alone.

Impact of Omeprazole and Fluvoxamine on Platelet Response to Clopidogrel [Not yet recruiting]
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.

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.

Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD) [Not yet recruiting]
This study will test the hypotheses that: 1. 12 weeks of Luvox-CR plus web-based Cognitive-Behavioral Therapy (CBT) [CT-STEPS] will produce greater symptom relief of OCD than treatment with Luvox-CR alone; and, 2. subjects receiving 12 weeks of CT-STEPS added to Luvox-CR treatment after 12-weeks of Luvox-CR monotherapy will experience greater OCD symptom relief (from weeks 12-24) than those continuing Luvox-CR treatment and having access to CT-STEPS from week one. 3. subjects who begin CT-STEPS at week 12 will be more likely to complete it than those who begin CT-STEPS at baseline.

Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes [Recruiting]
The investigators will compare plasma kinetics of two marker drugs in individuals with different genetic variations in the MDR1-gene. The hypothesis is that one group will have higher exposure than the other.

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

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.