Trends of reporting of 'serious'vs. 'non-serious' adverse drug reactions over time: a study in the French PharmacoVigilance Database.

What Is Already Known About This Subject: • Several factors are known to influence spontaneous reporting of adverse drug reactions (ADRs). Among them, 'seriousness' of the reaction is one of the most important. • However, evolution in the reporting of 'serious'vs.

Do Parkinson's disease patients disclose their adverse events spontaneously?

Background: Underreporting of adverse drug reactions is common but has been rarely studied in Parkinson's disease (PD).

Objective: To compare the prevalence of adverse events (AEs) in relation to antiparkinsonian drugs in PD patients using two different data collection methods: patient's spontaneous reporting versus a predefined investigator-driven structured interview. Secondary objectives were to assess factors related to spontaneous reporting and to compare the rate of AE reporting in PD patients with that of a group of non-parkinsonian post-stroke patients.

[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.

A comparative study of adverse drug reactions during two heat waves that occurred in France in 2003 and 2006.

Purpose: Heat waves could reveal or aggravate several 'serious' adverse drug reactions (ADRs) in elderly. Thus, we wanted to describe the main characteristics of heat-related 'serious' ADRs occurred in patients older than 70 years during these two events in France (2003 and 2006).

Methods: We analysed 'serious' ADRs reported to the network of French pharmacovigilance centres in summer 2003 and 2006 and suspected to be heat related.

The importance of drug-drug interactions as a cause of adverse drug reactions: a pharmacovigilance study of serotoninergic reuptake inhibitors in France.

Purpose: To quantify the importance of drug-drug interactions (DDIs) in the occurrence of adverse drug reactions (ADRs) reported with serotoninergic reuptake inhibitors in a pharmacovigilance database.

Methods: All spontaneous reports of ADRs registered in 2008 by the Midi-Pyrénées PharmacoVigilance Centre that contained mention of one of the serotoninergic reuptake inhibitor (SRI) antidepressants marketed in France were reviewed. DDIs were identified according to the French National Drug Formulary (Vidal) and the interaction supplement of the French independent drug bulletin La Revue Prescrire.

Drug-induced immune thrombocytopenia: a descriptive survey in the French PharmacoVigilance database.

The aim of this survey was to describe drug-induced immune thrombocytopenia (ITP) reported in the French PharmacoVigilance database (FPVD) and to discuss the drugs involved. The request to the FPVD used the seven most accurate diagnosis codes to identify ITP. The study was restricted to cases reported from 2007 to 2010 and at least "possible" according to the French causality assessment score.

Exposure to inhibitors of the renin-angiotensin system is a major independent risk factor for acute renal failure induced by sucrose-containing intravenous immunoglobulins: a case-control study.

Purpose: Risk factors for intravenous immunoglobulin-induced renal failure (IVIg-RF) were suspected from case series studies. This study was aimed at quantifying the risk of IVIg-RF associated with exposure to drugs that modify intrarenal hemodynamics.

Methods: We conducted a case-control study in the French Pharmacovigilance Database (FPVD).

Adverse drug reactions associated with the use of NSAIDs: a case/noncase analysis of spontaneous reports from the French pharmacovigilance database 2002-2006.

To evaluate the safety profile of eight oral nonsteroidal anti-inflammatory drugs (NSAIDs) available in France, using data reported through the French pharmacovigilance system. Data (from 2002 to 2006) were analysed for aceclofenac, diclofenac, ketoprofen, meloxicam, naproxen, nimesulide, piroxicam and tenoxicam, focusing on the reported rates of serious adverse drug reactions (ADRs) in the following system organ classes: gastrointestinal, hepatic, cutaneous, renal and cardiovascular. A total of 42 389 serious ADR reports were identified, and 38 506 were included in a case/noncase analysis.

Spinal anesthesia failure after local anesthetic injection into cerebrospinal fluid: a multicenter prospective analysis of its incidence and related risk factors in 1214 patients.

Background And Objectives: Different mechanisms have been proposed to explain spinal anesthesia failure even after LA injection into the subarachnoid space. The aim of this prospective multicenter study was to assess the incidence of spinal anesthesia failure, excluding technical problems, and then to suggest independent factors leading to failure.

Methods: Consecutive spinal anesthetic procedures performed in 21 centers were included.

Drug-induced parkinsonism: a review of 17 years' experience in a regional pharmacovigilance center in France.

Besides antipsychotics, several drugs can induce parkinsonism. We review spontaneous notifications of drug-induced or -worsened parkinsonism to a French regional pharmacovigilance center between 1993 and 2009. During these 17 years, 20,855 adverse drug reactions have been reported, including 155 (0.

Drug prescribing before and during pregnancy in south west France: a retrolective study.

Background: Several drugs that are known to exhibit teratogenic or fetotoxic risks when used during pregnancy should not be prescribed to pregnant women. However, most women of childbearing age use medications, and drug use cannot always be avoided during pregnancy, especially for women with chronic diseases for whom the benefit of treatment outweighs the potential risk of the drug for the fetus. Nevertheless, it is often possible to replace a drug with another one that has been better evaluated.

Prescribed drugs and violence: a case/noncase study in the French PharmacoVigilance Database.

Aim: Our aim was to identify prescribed drugs associated with violent behaviours using the French PharmacoVigilance Database (FPVD).

Methods: All reports of adverse drug reactions (ADR) recorded in the FPVD between 1 January 1985 and 31 July 2008 and including the terms aggressiveness or violence were selected. We compared proportion of exposure to different drugs between cases (reports with violence) and noncases (other reports in the database).

[Profile of psychoactive substances consumption in workplace].

Purpose: The aim of this study was to identify profiles of psychoactive substances consumers among workers according to their professional characteristics.

Methods: In 2006, 2213 workers participated in "Mode de Vie et Travail" (Drugs and Work) cross-sectional survey. Data were collected by a self-administered questionnaire concerning general and professional characteristics and the consumption of psychoactive substances (psychoactive drugs, tobacco, alcohol and cannabis) during the professional medical visit.

Pulmonary arterial hypertension and benfluorex: 5 case reports.

Benfluorex, an amphetamine derivative, was marketed as an adjunctive drug for patients with hypertriglyceridemia or diabetes with overweight. We describe here 5 cases of pulmonary arterial hypertension (PAH) associated to a treatment with this drug and notified to the Midi-Pyrénées Pharmacovigilance Centre. All cases are women, exposed to benfluorex during at least 3 years.

[Family pharmacy: survey of a sample of patients in Midi-Pyrénées].

Objective: Possession of drugs at home in the family pharmacy and self-medication are at risk.

Method: Appraisal based upon an analysis of 247 questionnaires completed by patients and 116 questionnaires completed by general practitioners in the French department of Haute Garonne (Southwestern, France).

Results: Two hundred and forty-four patients were involved in the study.

Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database.

Background: Thiazolidinediones (TZDs), rosiglitazone (RGZ) and pioglitazone (PGZ) are widely used as hypoglycemic drugs in patients with type 2 diabetes mellitus. The aim of our study was to investigate the profile of adverse drug reactions (ADRs) related to TZDs and to investigate potential risk factors of these ADRs.

Methods: Type 2 diabetic patients were identified from the French Database of PharmacoVigilance (FPVD) between 2002 and 2006.

Buprenorphine versus methadone in pregnant opioid-dependent women: a prospective multicenter study.

Patients And Methods: In order to investigate the effects of exposure to buprenorphine compared with methadone during pregnancy, a prospective multicenter study was conducted in collaboration with maternity hospitals, maintenance therapy centers, and general practitioners involved in addiction care. Ninety pregnant women exposed to buprenorphine and 45 to metadone were selected for the study.

Results: During pregnancy, some women were exposed to illicit agents: cannabis (42% in the buprenorphine group vs.

[Which analgesic after dextropropoxyphene withdrawal? A survey in a sample of general practitioners in southwest of France].

Following the announcement of the future withdrawal in Europe of drugs containing dextropropoxyphene-paracetamol (DXP-P), we performed a postal survey in a randomly selected sample of 350 general practitioners (GP) from the Midi-Pyrénées area (2.6 million inhabitants) in order to investigate which drug (s) they are willing to prescribe in anticipation of the announced withdrawal. Most of GP prescribed DXP-P in acute and chronic pain.

Antihypertensive drug prescription pattern before and during pregnancy in France.

Objective: This study provides firsthand information on antihypertensive prescriptions before and during pregnancy in France.

Methods: The study, on 23,898 women, was carried out using data from the French Health Insurance System.

Results: Before and during pregnancy, 1.

Life-threatening drug-associated hyperkalemia: a retrospective study from laboratory signals.

Purpose: Life-threatening hyperkalemia may be induced by drugs and preventable in at-risk patients. This study was designed to describe cases of 'serious' drug-associated hyperkalemia.

Methods: Adult subjects with a serum potassium concentration above 6.

Slow-release oral morphine for opioid maintenance treatment: a systematic review.

This review article summarizes the results of all available clinical trials considering the use of slow-release oral morphine (SROM) for opioid maintenance treatment (OMT). All studies published up to October 2010 and assessing SROM for OMT in adult patients are included. Three independent reviewers assessed the selected articles using a standardized checklist.