E-drug: Increased risk of suicide in children using SSRIs
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[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
2. 'Dear Colleague' letter from Chairman CSM, via Pubic Health
Link, 10 December 2003. Available from:
http://medicines.mhra.gov.uk
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