# \[e-drug\] Increased risk of suicide in children using SSRIs

**URL:** <https://talk.edrugplus.org/t/e-drug-increased-risk-of-suicide-in-children-using-ssris/19101>\
**Category:** e-drug\
**Created:** [March 17, 2004, 12:43pm UTC](https://talk.edrugplus.org/t/e-drug-increased-risk-of-suicide-in-children-using-ssris/19101 "2004-03-17T12:43:30Z")\
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**Author:** ![E-drug](https://avatars.discourse-cdn.com/v4/letter/e/ecd19e/32.png) [@E-drug](https://talk.edrugplus.org/u/E-drug)\
**Post date:** [March 17, 2004, 12:43pm UTC](https://talk.edrugplus.org/t/e-drug-increased-risk-of-suicide-in-children-using-ssris/19101/1 "2004-03-17T12:43:30Z")

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E-drug: Increased risk of suicide in children using SSRIs  
-------------------------------------------------------------------------

[WHO Pharmaceuticals Newsletter 1(1), 2004. Copied as fair use.  
For interested E-druggers, please make sure you get a copy of the  
book by Charles Medawar and Anita Hardon "Medicines Out of  
Control? - Antidepressants and the Conspiracy of Goodwill", which  
deals with the side-effects of this class of anti-depressants, not  
only in children. HH]

FDA warns of paediatric suicide risk; CSM reports poor paediatric  
benefit/risk profile with SSRIs

USA, UK. The United States Food and Drug Administration (FDA)  
has issued a Public Health Advisory alerting healthcare  
professionals to reports of suicidal ideation and suicide attempts in  
clinical trials of antidepressants in paediatric patients with major  
depressive disorder (MDD)1. Preliminary data from 20  
placebo-controlled trials involving the eight antidepressants  
citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone,  
paroxetine, sertraline and venlafaxine suggest an excess of reports  
of suicidality in paediatric patients assigned to some of these drugs  
compared with those assigned to placebo. The FDA has completed  
a preliminary review of such reports and determined that additional  
data and analysis, and a public discussion of available data is  
needed. The FDA emphasises that there have been no reports of  
completed suicides associated with the use of these anti-  
depressants. It also notes that the data were adequate to establish  
effectiveness in paediatric MDD only for fluoxetine (Prozac).  
Prescribers are reminded that all antidepressant labelling includes  
a warning about the possibility of suicide attempts inherent in MDD  
and that, close supervision of high-risk patients should accompany  
initial drug therapy.

The UK Committee on Safety of Medicines (CSM) has advised  
that, based on the review by the Expert Working Group, the  
balance of risks and benefits for the treatment of major depressive  
disorder (MDD) in under 18s is judged to be unfavourable for the  
Selective Serotonin Reuptake Inhibitors (SSRIs) sertraline,  
citalopram and escitalopram and un-assessable for fluvoxamine;  
only fluoxetine (Prozac) has been shown to have a favourable  
balance of risks and benefits in this age group2. The CSM had  
earlier also issued a warning that paroxetine and venlafaxine, two  
other SSRIs, should not be used in treating MDD in children and  
adolescents under the age of 18 years. In adults the benefits of  
treatment are considered to outweigh the risk for all SSRIs. None  
of the above mentioned drugs have ever been licensed for use in  
depressive illness in under-18s although their use in MDD in this  
population is known. Although fluoxetine does not have a  
marketing authorisation for MDD in the UK in under-18 year olds,  
the CSM has considered the clinical trial data and advised that the  
balance of risks and benefits is favourable. However, the decision  
to prescribe fluoxetine (or one of the other SSRIs in a patient who  
might be intolerant to fluoxetine) should only be made with  
specialist advice and after careful consideration of all available  
information. For those under 18 MDD patients, who are currently  
on an SSRI, the treatment must be gradually tapered off in order to  
avoid precipitating sudden-withdrawal reactions.

References:  
1. FDA Talk Paper T03-70, 27 October 2003. Available from:  
[http://www.fda.gov](http://www.fda.gov)  
2. 'Dear Colleague' letter from Chairman CSM, via Pubic Health  
Link, 10 December 2003. Available from:  
[http://medicines.mhra.gov.uk](http://medicines.mhra.gov.uk)

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