[Reports of suspected side effects of selective serotonin reuptake inhibitors in Belgium and The Netherlands].
OBJECTIVE
To study the adverse drug reaction (ADR) profile of selective serotonin re-uptake inhibitors (SSRI) in Belgium and the Netherlands.


METHODS
Descriptive study.


METHODS
The Belgian Pharmacovigilance Centre and the Dutch Drug Safety Unit.


METHODS
All adverse reactions of fluoxetine, fluvoxamine, paroxetine and sertraline, reported between the moment of registration of these drugs and January 1st 1995, were assessed for causality. Possible, probable and certain adverse reactions were counted per drug and per country.


RESULTS
At the national monitoring centres of Belgium and of the Netherlands adverse reactions were reported 78 and 537 times, respectively. Approximately 30% of the adverse reactions were well-established. Approximately 60% of the reactions were poorly documented or not serious. Less than 1% of the adverse reactions reported in Belgium and approximately 13% of the reactions reported in the Netherlands, were less established and/or serious. These reactions were: movement disorders and extrapyramidal reactions, convulsions, galactorrhoea, hyponatraemia and syndrome of inappropriate antidiuretic hormone secretion, and purpura.


CONCLUSIONS
The ADR profile was compatible with the ADR profile in the medical literature, but not all ADR were similarly represented in the product information of the different SSRI. More adverse reactions were reported in the Netherlands than in Belgium.
Van Ermen
A M
AM
Ministerie van Sociale Zaken, Volksgezondheid en Leefmilieu, Belgisch Centrum voor Geneesmiddelenbewaking, Brussel.
Ottervanger
J P
JP
Roisin
T
T
Kurz
X
X
Stricker
B H
BH
D015057:1-Naphthylamine / Q000009:adverse effects / Q000031:analogs & derivatives; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects; D001530:Belgium; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects; D016666:Fluvoxamine / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D017374:Paroxetine / Q000009:adverse effects; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects*; D020280:Sertraline
D015057:1-Naphthylamine; D000928:Antidepressive Agents; D005473:Fluoxetine; D016666:Fluvoxamine; D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline