Brintellix Adverse Reactions

Summary of the safety profile: The most common adverse reaction was nausea.
Tabulated list of adverse reactions: Adverse reactions are listed as follows using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). The list is based on information from clinical trials and post-marketing experience. (See table.)

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Description of selected adverse reactions: Nausea: Nausea was usually mild or moderate and occurred within the first two weeks of treatment. The reactions were usually transient and did not generally lead to cessation of therapy. Gastrointestinal adverse reactions, such as nausea, occurred more frequently in women than men.
Elderly patients: For doses ≥10 mg vortioxetine once daily, the withdrawal rate from the studies was higher in patients aged ≥65 years.
For doses of 20 mg vortioxetine once daily, the incidences of nausea and constipation were higher in patients aged ≥65 years (42% and 15%, respectively) than in patients aged <65 years (27% and 4%, respectively) (see Precautions).
Sexual dysfunction: In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX). Doses of 5 to 15 mg showed no difference to placebo. However, the 20 mg dose of vortioxetine was associated with an increase in treatment-emergent sexual dysfunction (TESD) (see Pharmacology: Pharmacodynamics under Actions). In the post-marketing setting cases of sexual dysfunction have also been reported with doses of vortioxetine below 20 mg.
Class effect: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a drug from related pharmacological classes of antidepressants (SSRIs or TCAs). The mechanism behind this risk is unknown, and it is not known if this risk is also relevant for vortioxetine.
Paediatric population: A total of 304 children aged 7 to 11 years and 308 adolescents aged 12 to 17 years with major depressive disorder (MDD) were treated with vortioxetine in two double-blind, placebo-controlled studies, respectively. In general, the adverse reaction profile of vortioxetine in children and adolescents was similar to that observed in adults except for a higher incidence of abdominal pain-related events, and a higher incidence of suicidal ideation in adolescents specially, compared to adults (see Pharmacology: Pharmacodynamics under Actions).
Two long-term open-label extension studies were performed with vortioxetine doses of 5 to 20 mg/day, and with a treatment duration of 6 months (N=662) and 18 months (N=94), respectively. Overall, the safety and tolerability profile of vortioxetine in the paediatric population after long-term use was comparable to what has been observed after short-term use.
Symptoms upon discontinuation of vortioxetine treatment: In the clinical studies, discontinuation symptoms were systematically evaluated following abrupt cessation of vortioxetine treatment. There was no clinically relevant difference to placebo in the incidence or nature of the discontinuation symptoms after treatment with vortioxetine (see Pharmacology: Pharmacodynamics under Actions). Cases describing discontinuation symptoms have been reported in the post-marketing setting and have included symptoms such as dizziness, headache, sensory disturbances (including paraesthesia, electric shock sensations), sleep disturbances (including insomnia), nausea and/or vomiting, anxiety, irritability, agitation, fatigue and tremor. These symptoms may occur within the first week of vortioxetine discontinuation.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Patient may report any side effects or adverse drug reactions directly to the National Centre for Adverse Drug Reaction Monitoring by calling Tel: 03-78835550, or visiting the website portal.bpfk.gov.my (Healthcare Professional→Reporting).