The type of memory affected could not be analysed because this information was often not described. In the FPVD, 519 cases of memory disorders were reported in the last 10 years. Despite these inherent limits of this type of study, case/noncase methodology is very useful to generate signals, especially in pharmacovigilance. Indeed, the association between a drug and an adverse drug effect could be decreased if another effect is more often reported by physicians, and vice versa. The limits of this methodology in the FPVD lie especially in the under-reporting of ADRs in general, and particularly in elderly people, and notoriety bias. Several studies have been recently published using this method on this database applying to different fields of drug safety but also to pharmacodependence. Thus, the case/noncase method is a very useful method for assessing and detecting associations between a specific adverse drug effect and exposure to drugs in real conditions of use, because it is simple and quick and the data used are already available. Preclinical data are often limited and clinical trials, although essential, are performed on a too small number of patients for detecting uncommon effects. The aim of this work was to assess which drugs could be implicated in the occurrence of memory disorders through a case/noncase study in the FPVD. Reporting odds ratio (95% confidence interval)Īnterograde amnesia (risk increasing with dosage) Mention in French Summary of Product Characteristics Seriousness was defined as an ADR leading to hospitalization (or prolongation of hospitalization), persistent or significant disability or incapacity, life threatening or death. If available, the following data were also collected from each report: age, sex, seriousness and evolution of the ADR. We selected drugs for which four or more reports of memory disorders had been registered in the FPVD. Noncases, using as controls, were all the remaining ADR reports recorded in the database during the same period.ĭrug exposition was defined by the presence in the report of the drug checked ‘suspect’ according to the World Health Organization criteria, whatever the level of causality assessment. In our study, we collected ADRs recorded in the FPVD between 1 January 2000 and 31 December 2009.Ĭases were defined as HLT (High Level Term, MedDRA 11.0, Medical Dictionary for Regulatory Activities) ‘memory loss (dementia excluded)’, including ‘amnesia’, ‘anterograde amnesia’, ‘global amnesia’, ‘memory disturbance’ and ‘amnesic disorder’. Since 1985, all ADR reports sent spontaneously by health professionals to one of the 31 French Regional Centres of Pharmacovigilance have been entered into the FPVD. The aim of this study was to investigate the putative association of reports of memory disorders (without dementia) and suspected drugs, using the case/noncase method in the French PharmacoVigilance Database (FPVD). Thus, analysis of the type of memory alteration can be used to incriminate more a particular drug during polymedication. The action of drugs on memory is more or less specific and serious depending on the memory system affected. It is established that there is a decrease of mnesic abilities with ageing, but iatrogenic responsibility may be evocated when a memory alteration occurs suddenly and/or recently in an elderly person without other symptoms of dementia. The impact of drugs on memory disorders is particularly pronounced in elderly people because of polymedication. Traditionally, it is considered that benzodiazepines and anticholinergic drugs are mainly responsible for this last form. Concerning transient amnesia, the main aetiologies are idiopathic transient global amnesia, epileptic, vascular, psychogenic and iatrogenic amnesia. Among the different patterns of memory disorders, the following two main forms of amnesia can be isolated: anterograde amnesia, when the subject cannot memorize new information and retrograde amnesia, when the subject is unable to recall events occured before the injury.Īmnesia can also be subdivided into long-term amnesia and short-term (or transient) amnesia. The human memory system is divided into the following three components: short-term memory, allowing recall for a period of several seconds to 1 min without rehearsal (one form is working memory) long-term explicit memory, concerning facts taken out of context (semantic memory) and concerning information specific to a particular context, such as time and place (episodic memory) and finally, implicit memory or procedural memory, based on implicit learning.Įvery stages of the process of memorization and all of the different components of memory can be affected in an isolated way or in association. Memory is defined as the ability to store, retain and recall information.
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