Lacosamide-induced personality changes: An unexpected adverse effect.

Objectives: To describe an 'unexpected' case of abrupt personality following the introduction of lacosamide.

Methods: A description of an 82-year-old male receiving neurological follow-up since 2010 due to epilepsy secondary to haemorrhagic stroke. We report a case of abrupt personality change in an 82-year-old male following the introduction of lacosamide with a return to the previous state after its discontinuation.

A European community pharmacy-based survey to investigate patterns of prescription fraud through identification of falsified prescriptions.

Aim: To identify prescription drugs involved in falsified prescriptions in community pharmacies in 6 European countries.

Methods: A cross-sectional survey among 2,105 community pharmacies in Belgium, France, Italy, the Netherlands, Spain and Sweden was carried out to collect all suspect prescription forms. For each reported drug, the number of reported falsified prescriptions per thousand inhabitants was estimated.

[Could we improve notification of adverse drugs reactions in hospital? Assessment of 5 years of network PharmacoMIP's activities].

Background: Spontaneous reporting of adverse drug reactions (ADR) is fundamental to drug safety surveillance (pharmacovigilance) and assessment of benefit/risk ratio. However, under-reporting remains the limit of the system.

Objective: The aim of this study was to assess the effect of regular visits of an Assistant in Clinical Research (CRA) on the improvement of ADR reporting in non-university hospitals.

Improving adverse drug reaction reporting in hospitals: results of the French Pharmacovigilance in Midi-Pyrénées region (PharmacoMIP) network 2-year pilot study.

Background: Spontaneous reporting of adverse drug reactions (ADRs) is fundamental to drug safety surveillance (pharmacovigilance); however, substantial under-reporting exists and is the main limitation of the system. Several factors could favour under-reporting.

Objective: The aim of this pilot study was to assess the effect of regular visits of a Clinical Research Assistant (CRA) on the improvement of ADR reporting in non-university hospitals.

Coxibs: evolution of prescription's behaviour in France.

The aim of the present study was, first to characterize profiles of coxibs' prescribers [general practitioners (GPs) and rheumatologists] in 2002 in France and, secondly, to identify factors associated with modification of this profile 1 year later. All GPs and rheumatologists from Midi-Pyrenees, Aquitaine, Languedoc-Roussillon and Pays de Loire areas (South of France: 11 050 000 inhabitants) were included in the study. For each practitioner, we used data concerning all non-steroidal anti-inflammatory drugs (NSAIDs) including coxibs reimbursed during period 1 (P1; January-March 2002) and period 2 (P2; January-March 2003).

[Drugs, Parkinson's disease and parkinsonian syndroms: recent advances in pharmacovigilance].

This paper reviews recent data on the pharmacovigilance of antiparkinsonian drugs and drugs inducing parkinsonian syndroms. Sudden sleep attacks were first described in 1999 with dopamine agonists. In fact, they can be induced by all the dopaminergic antiparkinsonian drugs.

[Meningococcal serogroup C vaccine: a pharmacovigilance point of view].

Background: In October 2002, the Midi-Pyrenees centre of pharmacovigilance (Southwest of France) was in charge of an extensive pharmacovigilance follow-up of a campaign of meningococcal serogroup C vaccination performed in the Hautes-Pyrénées area.

Objective: The purpose of this study was to evaluate the incidence, nature and seriousness of adverse drug reactions (ADRs) occurring during the 15 days after vaccination.

Methods: 'Immediate' and 'late' ADRs were recorded.

[Coxibs, which real therapeutic advance?: Recent pharmacoepidemiological data].

Therapeutic advance is defined by an improvement in effectiveness, safety and/or convenience. In this article, these three criteria were applied to currently marketed coxibs (celecoxib, rofecoxib), using data from clinical trials and pharmacoepidemiological studies. Risk of adverse drug reactions to coxibs, as evaluated by clinical trials, differs from that observed in real medical practice.

Opiate maintenance with buprenorphine in ambulatory care: a 24-week follow-up study of new users.

Background: Many studies suggest that buprenorphine, a long acting partial opioid agonist, may be comparable to methadone in efficacy, with fewer withdrawal symptoms and a lower risk of overdose. The aim of this study was to assess the patterns of buprenorphine prescription use in ambulatory care and retention rate under treatment during a 24-week follow-up period.

Methods: This observational cohort study included buprenorphine users identified from the French Health System prescription database in an area of 1 million inhabitants and followed for 24 weeks.

Risk of serious extrapyramidal symptoms in patients with Parkinson's disease receiving antidepressant drugs: a pharmacoepidemiologic study comparing serotonin reuptake inhibitors and other antidepressant drugs.

To compare the risk of occurrence of "serious" extrapyramidal symptoms (EPS) between selective serotonin reuptake inhibitors and other antidepressant drugs in patients with Parkinson's disease (PD), the authors performed a retrospective study using the French Pharmacovigilance Database (i.e., the database recording all serious adverse drug reactions reported in France by physicians to the National French Pharmacovigilance Network).