Abstract
Psychotropics are among the most widely used drugs, which makes their safety monitoring absolutely crucial. This monitoring is also especially important given the frequency and potential seriousness of adverse effects related to psychotropic drug use. The impact of benzodiazepine use, for instance, has been estimated to more than 20,000 serious falls per year in French elderly, around 2000 of these being fatal. None of the antidepressants existing is considered completely safe. If serotonin reuptake inhibitors have extremely low cardiac toxicity compared to tricyclic antidepressants, they can still be incriminated for QT prolongation and have been shown to significantly increase the risk of bleeding. Finally antipsychotics are associated with numerous serious side effects that only appear acceptable with regard to the seriousness of their indication. However, drug monitoring is not an end in itself; it has to be associated to a specific goal. Apart from safety signal detection and risk confirmation, the usual objectives of pharmacovigilance and pharmacoepidemiology, it needs to help clinicians to choose which therapeutic they should consider within those presenting a benefit in a given indication. The tools that can be used for the post-marketing monitoring of psychotropics safety include (i) pharmacovigilance and individual case analysis, (ii) pharmacoepidemiology and population data analysis and (iii) meta-analysis and clinical trial data analysis. In the following sections, we will present the interests, pitfalls and complementarity of these three approaches for this monitoring activity.
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Salvo, F., Fourrier-Réglat, A., Moore, N., Bégaud, B., Pariente, A. (2016). Methods for the Post-Marketing Monitoring of Psychotropics Safety: Interests and Pitfalls. In: Spina, E., Trifirò, G. (eds) Pharmacovigilance in Psychiatry. Adis, Cham. https://doi.org/10.1007/978-3-319-24741-0_3
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