Risk of relapse after natalizumab withdrawal: Results from the French TYSEDMUS cohort.

Objective: To assess disease activity within 12 months after natalizumab (NZ) discontinuation in a large French postmarketing cohort.

Methods: In France, patients exposed at least once to NZ were included in the TYSEDMUS observational and multicenter cohort, part of the French NZ Risk Management Plan. Clinical disease activity during the year following NZ discontinuation was assessed in this cohort.

Guillain-Barré syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccines: a multinational self-controlled case series in Europe.

Background: The risk of Guillain-Barré syndrome (GBS) following the United States' 1976 swine flu vaccination campaign in the USA led to enhanced active surveillance during the pandemic influenza (A(H1N1)pdm09) immunization campaign. This study aimed to estimate the risk of GBS following influenza A(H1N1)pdm09 vaccination.

Methods: A self-controlled case series (SCCS) analysis was performed in Denmark, Finland, France, Netherlands, Norway, Sweden, and the United Kingdom.

First French experience of ADR reporting by patients after a mass immunization campaign with Influenza A (H1N1) pandemic vaccines: a comparison of reports submitted by patients and healthcare professionals.

Background: Available data concerning the contribution of patient adverse drug reaction (ADR) reporting in practice are scarce. Few studies have compared patients' reports with reports from healthcare professionals (HCPs). During the 2009-10 mass immunization campaign with A (H1N1)v2009 pandemic influenza vaccines, a reinforced pharmacovigilance plan was introduced in France according to European Medicines Agency recommendations.

[National Campaign of Vaccination against the flu A (H1N1)v: National Follow-up of Pharmacovigilance].

Objectives: The present study was performed to evaluate safety data collected by the French Network of Pharmacovigilance centres network, from October 21, 2009 to June 15, 2010.

Methods: French Health Authorities (Afssaps [Agence française de sécurité sanitaire des produits de santé]) heightened awareness to extensive notifications with online health practitioners' reports and patients' reports via the Regional Centre concerned.

Results: During the campaign, 4.

Road traffic crashes and prescribed methadone and buprenorphine: a French registry-based case-control study.

Background: Opioids have been shown to impair psychomotor and cognitive functioning in healthy volunteers with no history of opioid abuse. Few or no significant effects have been found in opioid-dependant patients in experimental or driving simulation studies. The risk of road traffic crash among patients under buprenorphine or methadone has not been subject to epidemiological investigation so far.

Role of the post-marketing authorisation studies in drug risk surveillance: specifications and methodologies.

Studies conducted after the marketing authorisation with the objective of identification, characterization or quantification of one or more risks (called PASS "Post-Authorisation Safety Studies"), have been strengthened in the past years with the implementation of the concept of risk management plans (RMPs), established in 2005 in the European regulatory framework and recently amended as part of the community revision. These safety studies, interventional or not, are related to a marketed drug, whether or not the drug is used within the market authorisation conditions. Apart from these safety studies, other studies whose primary objective is not risk assessment, including assessment of efficacy, description of prescription data and use in real life, pharmacokinetics, public health impact .

[Drugs and heat wave: SIRIUS, a multicentric case-control study in patients older than 65 years during 2007 summer in France].

Objective: To evaluate in real conditions the role of drugs in heat-related adverse effects.

Methods: We performed a multicentric case-control study in 3 university hospitals in France, including 36 cases (patients older than 65 years hospitalized with hyperthermia or dehydration between 1st July and 31st August 2007) and 51 controls. We compared drugs and changes in drug dosage according to the values of renal function.

The impact of medicinal drugs on traffic safety: a systematic review of epidemiological studies.

Purpose: To evaluate the quality of epidemiological research into effects of medicinal drugs on traffic safety and the current knowledge in this area.

Data Sources: The bibliographic search was done in Medline electronic database using the keywords: ((accident* or crash*) and traffic and drug*) leading to 1141 references. Additional references were retrieved from the Safetylit website and the reference lists of selected studies.

[Adverse drug reactions: a pilot study on patient reporting through patient associations].

Background: The expected evolution of monitoring systems for health products, aims at increasing the involvement of patients into health products safety system. As a result, it seems necessary to consider the ability for patients to directly report their own adverse events.

Methods: A pilot study has been undertaken by Afssaps (Health Agency) for 23 patient associations using a reporting form specially created for patients.