Drug-induced hallucination: A case/non case study in the French Pharmacovigilance Database

ABSTRACT -Background and Objectives: Hallucinations are sensory perceptions which occur without external stimuli. There are associated with psychiatric disease but also can be related to organic disease and drug or toxic exposure. The purpose of our study was to investigate the association between exposure to medications and the reporting of hallucinations using data from the spontaneous-reporting French Pharmacovigilance Database (FPVD). Methods: We used the case/noncase method in the FPVD. Cases were all the observations of hallucination with the LLT term "perception disturbances", registered into the FPVD from January 1985 to Jan 2013. Data were expressed as odds ratio (OR) with their 95% confidence intervals. Results: Among the 469,181 reports of adverse effects recorded between 1985 and 2013, 4,086 are hallucinations. For about 50% of these hallucinations were experimented by patient older than 65 years old. A statistically significant OR was found with several medications included rasagiline ]), zolpidem , methylphenidate ) and baclofene ). An increased risk of hallucinations was also observed with non central nervous system drugs, including ertapenem .5]), voriconazole ) and valacyclovir ]). Conclusions: This pharmacoepidemiological study describes an association between drugs and hallucinations. This relationship involves not only some already suspected drugs but also other drugs less known to induce such an adverse reaction. Despite the mandatory limits of this kind of study, these data should lead to special precautions in patient at risk

Hémophilie acquise (étude rétrospective et prospective au CHU de Toulouse)

BORDEAUX2-BU Santé (330632101) / SudocSudocFranceF

Eosinophilic pneumonia induced by non-steroidal anti-inflammatory drugs: An underestimated risk

International audienc

Les effets indésirables médicamenteux graves et leur évitabilité chez des sujets âgés de plus de 65 ans

Objectif. Décrire les effets indésirables médicamenteux (EIM) graves chez des sujets âgés de plus de 65 ans et évaluer leur évitabilité. Méthodes. Une étude rétrospective a été réalisée au Centre Régional de Pharmacovigilance (CRPV) de Champagne-Ardenne entre janvier et mai 2013. Les patients âgés de plus de 65 ans ayant présenté un EIM grave notifié au CRPV ont été inclus dans l’étude. Résultats. Sur la période étudiée, 100 sujets ont été inclus dans l’étude. Le sex ratio était de 0,96. Vingt-sept pour cent des EIM graves étaient évitables. Le non respect de l’autorisation de mise sur le marché (AMM) représentait 20 % et l’inobservance 5 %. Les accidents hémorragiques étaient les EIM les plus fréquents (36 %). Les anti-thrombotiques étaient les médicaments les plus souvent suspectés dans la survenue des EIM (31,4 %). Conclusion. Plus d’un quart des EIM graves étaient évitables. Le non-respect de l’AMM et l’inobservance sont les principales causes mises en évidence dans les EIM graves évitables

Les effets indésirables médicamenteux en pédiatrie : expérience d’un centre régional de pharmacovigilance

International audienc

The French Pharmacovigilance Surveys: A French Distinctiveness, a Real Input

International audienceINTRODUCTION: According to French guidelines on good pharmacovigilance practices, a pharmacovigilance survey is an assessment of the available drug safety data. It is requested by the French national agency for medicines and health products safety (ANSM). The objective is to validate a signal, to characterize it, or to provide strengthened monitoring of a drug. MATERIAL AND METHODS: All the available data were retrieved by ANSM/Regional Pharmacovigilance Centers (RPC) and assessed by a nominate RPC which provides a report for discussion during the monthly Committee between ANSM and the Regional Pharmacovigilance Network (RPN). A descriptive analysis of the minutes available on the ANSM website between 2016 and 2018 has been done: objective, data sources, duration of the survey, number of suspected adverse drug reactions, nature of the drugs and of the signals and recommendations for actions. RESULTS: Between 2016 and 2018, a total of 115 surveys were discussed concerning 135 drugs, mainly from the nervous system according to the anatomic therapeutic chemical classification (n=31, 27%). They involved a whole pharmacological class for 18 ones. The main objective of the 115 surveys was to provide a strenghtened monitoring for some drugs (72%) or to validate one or more than one signal (28%). Result from surveys allowed to detect one or several new potential safety signals in 63 ones (55%), an off-label-use in 12 (10%) or to characterize some others signals in all the studies. The Committee recommended one or several actions by survey: 67 prolongations (58%) of the survey and regulatory or investigatory actions which included 43 European actions (37%), 37 label changes (32%), 30 national communications (26%) and 29 additional monitoring (25%). DISCUSSION/CONCLUSION: The current process allows a collegiate, clinical and pharmacological discussion with integration of the regulatory framework. A significant number of new signals are detected and/or validated. This efficient tool which is unique in Europe and is allowed by the decentralized pharmacovigilance which leads to a great reactivity of decision-making. It has to be reassessed and to be adapted continuously to the new challenges of the growing multiplication of signals