Written Question · S1W-30788 · Session 1
Which anti-depressant and anti-psychotic drugs are currently approved for use in children and what trials were carried out before this appr…
The question
To ask the Scottish Executive which anti-depressant and anti-psychotic drugs are currently approved for use in children and what trials were carried out before this approval was given.
The answer
The regulation and safety of medicines is reserved and is the responsibility of the Medicines Control Agency (MCA). The following information has been provided by the MCA: AntipsychoticsThe following "typical" antipsychotics are authorised for the treatment of psychotic disorders (e.g. schizophrenia and autism) in children: chlorpromazine, haloperidol, levomepromazine/methotrimeprazine, pericyazine and trifluoperazine. For these older drugs, the dosage recommendations are mainly based on long established use in clinical practice. Another well-established anti-psychotic, prochlorperazine, is authorised for use in children in nausea and vomiting only. None of the newer "atypical" anti-psychotics is authorised for use in children.Anti-depressantsCurrently, no medicines are authorised for the treatment of children and adolescents with depression.Two of the newer selective serotonin uptake inhibitor (SSRI) anti-depressants, fluvoxamine and sertraline, have been authorised for use in children suffering from obsessive compulsive disorder (OCD) and the dosage recommendations are based on clinical trial data. These data are held on file by the marketing authorisation holder and the competent authority.Three of the older tricyclic anti-depressants, amitriptyline, imipramine and nortriptyline, are authorised for use in children with nocturnal enuresis (bed-wetting). For these long-established medicines, dosage recommendations are mainly based on prescribers' experience in marketed use, rather than the robust clinical trial data that would now be required for the licensing of new medicines.
In the Official Report
No contribution in the Official Report cites S1W-30788 by reference.