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1 Selective serotonin reuptake inhibitors (SSRI) – sales, withdrawal ...

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2002 Ad Hoc Expert Meeting 21 November<br />

on the safety of <strong>SSRI</strong>s<br />

2003 DKMA Danish Medicines Agency<br />

(19 June 2003). Summary of Product<br />

Characteristics for Serorex<br />

(paroxetine)<br />

http://www.produktresume.dk/docushare/dsweb/Get/Document-<br />

14813/Serorex%2C+filmovertrukne+tabletter+20+mg.doc<br />

2003 DKMA Lægemiddelstyrelsen (2003).<br />

Antidepressive midler under vurdering<br />

(Antidepressants under assessment).<br />

2003 Meeting of the CSM Expert group on<br />

the safety of <strong>SSRI</strong>s held on<br />

Tuesday 22nd July.<br />

stopping but they<br />

are not drugs of<br />

dependence.<br />

The Group did not<br />

consider that<br />

<strong>withdrawal</strong><br />

reactions and<br />

dependence were<br />

synonymous. The<br />

Group did not<br />

consider that <strong>SSRI</strong>s<br />

caused dependence.<br />

[Though abstinence<br />

reactions can occur<br />

at discontinuation,<br />

all preclinical and<br />

clinical data do not<br />

indicate that <strong>SSRI</strong>s<br />

cause dependence]<br />

[It is important to<br />

emphasize that it is<br />

about<br />

discontinuation<br />

symptoms and not<br />

actual dependence<br />

to the drugs.]<br />

The group<br />

commented that it<br />

was a challenge to<br />

disseminate the<br />

information [about<br />

<strong>withdrawal</strong><br />

reaction] in such a<br />

way that informed<br />

patients of the risks<br />

but did not stop<br />

them taking the<br />

medication.<br />

2003 Committee on Safety of Medicines No strong evidence<br />

has been identified<br />

to suggest that<br />

<strong>SSRI</strong>s cause other<br />

features of<br />

dependence.<br />

2003 WHO Expert Committee on drug<br />

dependence WHO Techical Report<br />

series no 915. Thirty third report.<br />

WHO Geneve.<br />

Three <strong>SSRI</strong>s are<br />

among the 30<br />

highest-ranking<br />

drugs in the list of<br />

Minutes<br />

SPC<br />

Article to the<br />

public because<br />

of media<br />

referring to<br />

problems with<br />

the<br />

antidepressants.<br />

Minutes<br />

Minutes<br />

Technical<br />

report

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