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Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Other psychiatric conditions for which fluvoxamine are prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. Therefore when treating patients with other psychiatric disorders, they should be closely monitored.
Patients with a history of suicide-related events and those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Akathisia/psychomotor restlessness: The use of fluvoxamine has been associated with the development of akathisia, characterized by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.
Nervous system disorders: Although in animal studies fluvoxamine has no pro-convulsive properties, caution is recommended when the drug is administered to patients with a history of convulsive disorders. Fluvoxamine should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. Treatment with fluvoxamine should be discontinued if seizures occur or if seizure frequency increases.
On rare occasions, development of a serotonin syndrome or neuroleptic malignant syndrome-like events have been reported in association with treatment of fluvoxamine, particularly when given in combination with other serotonergic and/or neuroleptic drugs. As these syndromes may result in potentially life-threatening conditions, treatment with fluvoxamine should be discontinued if such events (characterised by clusters of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma) occur and supportive symptomatic treatment should be initiated.
Metabolism and nutrition disorders: As with other SSRIs hyponatremia has been rarely reported and appears to be reversible when fluvoxamine is discontinued. Some cases were possibly due to the syndrome of inappropriate antidiuretic hormone secretion. The majority of reports were associated with older patients.
Glycaemic control may be disturbed (i.e., hyperglycaemia, hypoglycaemia, decreased glucose tolerance), especially in the early stages of treatment. When fluvoxamine is given to patients with a known history of diabetes mellitus, the dosage of anti-diabetic drugs may need to be adjusted.
Nausea, sometimes accompanied by vomiting, is the most frequently observed symptom associated with fluvoxamine treatment. This side effect usually diminishes within the first two weeks of treatment.
Eye Disorders: Mydriasis has been reported in association with SSRIs such as fluvoxamine. Therefore, caution should be used when prescribing fluvoxamine in patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma.
Haematological disorders: There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura as well as other haemorrhagic manifestations, such as gastrointestinal bleeding or gynaecological/postpartum haemorrhage, with SSRIs. Caution is advised in patients taking SSRIs, particularly in elderly patients and in patients who concomitantly use drugs known to affect platelet function (e.g. atypical antipsychotics and phenothiazines, most TCAs, acetylsalicylic acid, NSAIDs) or drugs that increase risk of bleeding as well as in patients with a history of bleeding disorders and in those with predisposing conditions (e.g. thrombocytopenia, or coagulation disorders).
SSRIs may increase the risk of postpartum haemorrhage (see Use in Pregnancy & Lactation, and Adverse Reactions).
Cardiac disorders: When combined with fluvoxamine plasma concentrations of terfenadine, astemizole or cisapride may be increased resulting in an increased risk for QT-prolongation/Torsade de Pointes. Therefore, fluvoxamine should not be co-administered with these drugs.
Fluvoxamine may cause an insignificant decrease in heart beat (2-6 beats per minute).
Electroconvulsive therapy (ECT): There is limited clinical experience of concomitant administration of fluvoxamine and ECT; therefore caution is advisable.
Withdrawal reactions: It is possible that withdrawal reactions may occur on stopping therapy with fluvoxamine, although the available preclinical and clinical evidence does not suggest that this causes dependence.
The most commonly reported symptoms in association with withdrawal of the product include: dizziness, sensory disturbances (including paraesthesia, visual disturbances and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation, irritability, confusion, emotional instability, headache, nausea and/or vomiting, diarrhoea, sweating, palpitations, tremor and anxiety (see Adverse Reactions). Generally, these events are mild to moderate and are self-limiting; however in some patients they may be severe and/or prolonged. They usually occur within the first few days of discontinuing treatment. It is therefore advised that fluvoxamine should be gradually tapered when discontinuing treatment according to the patient's needs (see Dosage & Administration).
Mania/Hypomania: Fluvoxamine should be used with caution in patients with a history of mania/hypomania. Fluvoxamine should be discontinued in any patient entering a manic phase.
Sexual dysfunction: Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see Adverse Reactions). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.
Effects on ability to drive and use machines: Fluvoxamine up to 150 mg has no or negligible influence on the ability to drive and use machines. It showed no effect on psychomotor skills associated with driving and operating machinery in healthy volunteers. However, somnolence has been reported during treatment with fluvoxamine. Therefore, caution is recommended until the individual response to the drug has been determined.
Renal and hepatic impairment: Patients suffering from hepatic or renal insufficiency should start on a low dose and be carefully monitored.
Treatment with fluvoxamine has rarely been associated with an increase in hepatic enzymes, generally accompanied by clinical symptoms. In such cases treatment should be discontinued.
Use in Children: Fluvoxamine should not be used in the treatment of children and adolescents under the age of 18 years except for patients with OCD. Due to lack of clinical experience the use of fluvoxamine in children for the treatment of depression cannot be recommended. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressant compared to those treated with placebo. If based on clinical need, a decision to treat is taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive behavioural development are lacking.
Young adults (ages 18 to 24 years): A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Use in the Elderly: Data in elderly subjects give no indication of clinically significant differences in normal daily dosages compared to younger subjects. However upward dose titration should be done slower in the elderly, and dosing should always be done with caution.
