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.
Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo controlled clinical trials of antidepressants 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.
Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted to 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.
Seizures: Seizures are a potential risk with antidepressants. Therefore, Brintellix (Vortioxetine hydrobromide) should be introduced cautiously in patients who have a history of seizures or in patients with unstable epilepsy (see Interactions). Treatment should be discontinued in any patient who develops seizures or for whom there is an increase in seizure frequency.
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS): Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS), potentially life-threatening conditions, may occur with Brintellix (Vortioxetine hydrobromide). The risk of SS or NMS is increased with concomitant use of serotonergic active substances (including triptans), medicinal products that impair the metabolism of serotonin (including MAOIs), antipsychotics, and other dopamine antagonists. Patients should be monitored for the emergence of signs and symptoms of SS or NMS (see Contraindications and Interactions).
Serotonin Syndrome symptoms include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, uncoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea). If this occurs, treatment with Brintellix (Vortioxetine hydrobromide) should be discontinued immediately and symptomatic treatment should be initiated.
Mania/hypomania: Brintellix (Vortioxetine hydrobromide) should be used with caution in patients with a history of mania/hypomania and should be discontinued in any patient entering a manic phase.
Haemorrhage: Bleeding abnormalities, such as ecchymoses, purpura and other haemorrhagic events, such as gastrointestinal or gynaecological bleeding, has been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs). Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function [e.g., atypical antipsychotics and phenothiazines, most tricyclic antidepressants, non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (ASA)] (see Interactions) and in patients with known bleeding tendencies/disorders.
Hyponatraemia: Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs). Caution should be exercised in patients at risk, such as the elderly, patients with cirrhosis of the liver or patients concomitantly treated with medications known to cause hyponatraemia.
Discontinuation of Brintellix (Vortioxetine hydrobromide) should be considered in patients with symptomatic hyponatraemia and appropriate medical intervention should be instituted.
Renal impairment: Limited data is available for patients with severe renal impairment. Caution should therefore be exercised (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Vortioxetine has not been studied in patients with severe hepatic impairment and caution should be exercised when treating these patients (see Pharmacology: Pharmacokinetics under Actions).
Effects on ability to drive and use machines: No significant impairment, relative to placebo, in driving performance, cognitive function or other psychomotor skills (using a battery of neuropsychological tests) was observed when healthy subjects were administered single and multiple doses of 10 mg/day vortioxetine.
However, as adverse reactions such as dizziness have been reported, patients should exercise caution when driving or operating hazardous machinery.
Use in Children: Brintellix (Vortioxetine hydrobromide) is not recommended for the treatment of depression in patients aged less than 18 years since the safety and efficacy of Vortioxetine have not been established in this age group (see Dosage & Administration). In clinical studies in children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour, anger) were more frequently observed than in those treated with placebo.