DRUG SURVEILLANCE OF NEW ANTIDEPRESSANTS - EVALUATION OF NEUROBEHAVIORAL IMPACT

Drug surveillance data can be obtained from different sources: spontan eous French and European reporting, data from WHO, bibliographic analy sis. We are more interested, in this paper, in the type of data obtain ed than in the surveillance of each antidepressant. Our study is focus ed on psychiatric and neurobehavioural effects of antidepressants. The French drug surveillance database was examined for reactions associat ed with fluoxetine. Psychiatric side effects are not the most frequent . The psychiatric safety profiles of the three SSRIs (fluoxetine, fluv oxamine and paroxetine) are similar. However withdrawal reactions with fluvoxamine and paroxetine occur in a greater proportion of reports ( 13 and 14 per cent) than with fluoxetine (1.5 per cent). In contrast, pharmacodependance was observed in 79 per cent of reports with aminepi ne. Tricyclic antidepressants do not seem to confer increased risk of teratogenesis. Preliminary data regarding risk of prenatal exposure to fluoxetine suggest that its use during pregnancy is relatively safe. Data regarding neurobehavioural effects of prenatal exposure are lacki ng for all antidepressants. Cognitive disorders induced by antidepress ants are complex, due to the involvement of several factors that can i ntervene in the pathogenesis and evaluation of these disorders : most studies evaluate the modifications of neurobehavioural effects in heal thy subjects, few studies concern chronic patients. Proposals are made to improve the evaluation of these side effects.