By Edoardo Spina

The first authoritative textbook particularly addressing problems with the sector, this booklet can provide a centred dialogue on a number of topics in psychiatry whereas delivering a valid historical past on pharmacovigilance.

Internationally-recognised researchers, clinicians and pharmacovigilance specialists contributed to this textbook, giving it the good thing about diverse views and years of expertise. Pharmacovigilance in psychiatry offers an intensive creation to this box yet is going directly to discover complex subject matters corresponding to methodologies and assets used for pharmacovigilance in psychiatry, demanding situations in addition to most up-to-date advancements to this box, making it appropriate for under-graduates, graduate and post-doctoral scholars and individuals operating pharmacovigilance who search to develop their wisdom in this subject.

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5) (Ray et al. 2009). Assuming that antipsychotics as a class increase the risk of sudden cardiac death by 300 %, no more than 45–50 cases of sudden cardiac death would be expected in these RCTs for the 15 antipsychotics considered together. This is 40 F. Salvo et al. clearly insufficient to allow the comparison of risk of sudden cardiac death between individual antipsychotics using RCT data. One can assume that meta-analysis of RCTs is of limited interest when rare or very rare events are studied.

They explain it as follows: “Confounding is a mixing or blurring of effects. A researcher attempts to relate an exposure to an outcome, but actually measures the effect of a third factor, termed a confounding variable. ” We will therefore give some famous example of confounding that occurred, were suspected or are still present in the context of psychotropic post-marketing assessment. 3 Methods for the Post-Marketing Monitoring of Psychotropics Safety 37 One such example concerns the potential association between antipsychotic use and myocardial infarction (MI) in patients with psychosis.

This situation is made even more complex by the very long prodromal phase of dementia, in which pathological lesion and prodromal symptoms can be observed more than 20 years and more than 10 years before diagnosis, respectively. Two different studies were published in the BMJ specifically regarding the potential increase in the risk of dementia associated with the use of benzodiazepines. To deal with the potential protopathic bias, the authors used different methods. The first study (Billioti de Gage et al.

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