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18 May 2004:
Use of SSRIs and related antidepressants in children and adolescents

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The Pharmacovigilance Advisory Committee (PVAC) of the Health Sciences Authority (HSA) has recently reviewed the emerging concerns on the use of selective serotonin reuptake inhibitors (SSRIs) and related antidepressants in children and adolescents. The review was done in consultation with experts in the field of psychiatry.


Background

In recent months, there has been concern raised internationally about the increased risk of suicidal ideation and self-harm behaviour in children and adolescents who are prescribed these drugs for the treatment of major depressive disorders (MDD). The PVAC has reviewed the reports from the UK Committee on Safety of Medicines (CSM), US Food and Drug Administration (FDA) advisory committees and the American College of Neuropsychopharmacology.

The antidepressants available in Singapore that are affected by this review include the following 9 drugs: bupropion, citalopram, escitalopram, fluoxetine, fluvoxamine, mirtazepine, paroxetine, sertraline and venlafaxine (See Table below for further details).


Current data not conclusive

The PVAC notes that the available data to-date does not clearly establish an association between the use of these drugs and increased suicidal thoughts or actions in paediatric patients. Nevertheless, neither is it possible at this point to rule out an increased risk of these adverse events for any of these drugs until more data is available.

It would be worthwhile for healthcare professionals to note that none of these drugs is licensed in Singapore for treating major depressive disorders (MDD) in children and adolescents based on data submitted at point of marketing authorisation.


Management of paediatric MDD

In view of the above recent safety concerns, HSA advises that the use of any SSRIs and related antidepressants in children and adolescents with MDD should be undertaken only within the context of comprehensive management of the patients, as outlined in the Clinical Practice Guidelines on Depression recently issued by MOH. Physicians should carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either increases or decreases.

In addition, the choice of an SSRI for children and adolescents with MDD should be made only after taking into account the recent reports put up by the the UK and the US drug regulatory authorities as indicated in para 2. Please also note that the current local package inserts for paroxetine and venlafaxine recommend against their use in children and adolescents.

Children and adolescents who are currently being treated for MDD with any of these antidepressants should not have their medications ceased abruptly as there may be withdrawal symptoms associated with abrupt discontinuation.

HSA is working with the relevant pharmaceutical companies to reinforce the labelling on the package inserts of all the SSRIs and related antidepressants to reflect the need for stronger warnings for close monitoring for worsening depression and increase suicidality among children and adolescents with MDD prescribed with SSRIs and related antidepressants.

Table 1: List of registered oral SSRIs and related antidepressants in Singapore

No.
Antidepressant
Product Name
Available strengths
1
Bupropion
Wellbutrin SR tablet
150 mg
2
Citalopram
Cipram  tablet
20 mg
3
Escitalopram
Lexapro tablet
5 mg, 10 mg, 15 mg, 20 mg
4
Fluoxetine
APO-Fluoxetine capsule
10 mg, 20 mg
Deprexin capsule
20 mg
Fluoxetine capsule
20 mg
Fluoxone Divule tablet
20 mg
Fluxetil capsule
20 mg
Fluxetin capsule
20 mg
Foxtin-20 capsule
20 mg
Magrilan capsule
20 mg
PMS-Fluoxetine capsule
20 mg
Proctin capsule
20 mg
Prodep capsule 
20 mg
Provatine tablet
10 mg, 20 mg
Prozac 20 capsule
20 mg
Prozac Dispersible tablet
20 mg
Zactin capsule
20 mg
5
Fluvoxamine
Faverin tablet
50 mg, 100 mg
Fluvoxamine Maleate tablet
50 mg, 100 mg
6
Mirtazapine
Remeron tablet
15 mg, 30 mg, 45 mg
Remeron Soltab
15 mg, 30 mg, 45 mg
7
Paroxetine
Seroxat tablet
20 mg, 30 mg
8
Sertraline
Zoloft tablet
50 mg, 100 mg
9
Venlafaxine
Efexor XR capsule
75 mg, 150 mg
Efexor tablet
37.5 mg, 50 mg, 75 mg


Last updated on 07 Aug 2013 19:14:38
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