[Serious adverse drug reactions with tramadol reported to the French pharmacovigilance database between 2011 and 2015].

Background: Tramadol is an opioid and a serotonin reuptake inhibitor drug. It is approved for moderate to severe pain in adults. The aim of this study was to assess tramadol safety through a national pharmacovigilance study in France since dextropropoxyphen withdrawal in 2011.

Drug-induced panic attacks: Analysis of cases registered in the French pharmacovigilance database.

Background: The potential role of drugs in the onset of panic attacks (PAs) is poorly understood.

Aim: The objective of our study was to characterize drug-induced PAs.

Method: We performed an analysis of PAs registered in the French pharmacovigilance database between 01/01/1985 and 05/11/2014.

[Improving adverse drug reaction reporting by general practitioners through clinical research assistants visits].

The main limitation of adverse drug reactions (ADRs) reporting, particularly by general practitioners (GP), to the regional pharmacovigilance centers is under-reporting. The Midi-Pyrénées Regional Pharmacovigilance Center (South western, France) sets up regular visits by a clinical research assistant (CRA) to GP in order to increase the number of ADR reports. The aim of this pilot study was to assess the effect of regular visits of a CRA in GPs offices on the rate of ADR reporting.

Mania associated with ranitidine: a case report and review of literature.

H2 receptor antagonists can be associated with central adverse drug reactions (ADRs), like confusion, delirium, hallucinations, slurred speech or headaches. We report here a 'serious' case of severe mania leading to hospitalization in a 42-year-old alcohol-dependent man, 4 days after ranitidine introduction. Review of literature showed that this 'very rare' ADR occurs mainly in patients with predisposing factors: age, decrease in renal and/or hepatic function, polymedication, alcohol.

Pharmacovigilance, risks and adverse effects of self-medication.

Self-medication means resorting to one or more drugs in order to treat oneself without the help of a doctor. This phenomenon is developing fast. In this review, we will discuss the main definitions of self-medication; we will then present a few important characteristics of this therapeutic practice: prevalence, reasons, populations involved and drugs used.

Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrénées PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs).

Serotonin Syndrome: Analysis of Cases Registered in the French Pharmacovigilance Database.

Background: More information would be required for a better understanding of the actual circumstances of serotonin syndrome (SS) occurrence in routine clinical practice.

Aim: The objective of the study was to analyze characteristics of SS French pharmacovigilance reports, especially involved drugs and nature of drug-drug interactions (DDIs).

Method: We performed a retrospective analysis of SS registered in the French pharmacovigilance database between January 1, 1985 and May 27, 2013.

Online reporting of adverse drug reactions: a study from a French regional pharmacovigilance center.

Background: In France, online reporting via a website is a new method for notifying adverse drug reactions (ADRs). The French Midi-Pyrénées Regional Pharmacovigilance Center (RPVC) set up in July, 2010 a Web-based ADR reporting tool in order to improve ADR reporting rate.

Objectives: To assess feasibility, use and performances of this new ADR reporting system.

["Serious" adverse drug reactions with tramadol: a 2010-2011 pharmacovigilance survey in France].

Objective: Tramadol is a weak opioid used as a step 2 analgesic, approved in France for moderate to severe pain. After dextropropoxyphene withdrawal, a national pharmacovigilance follow-up of tramadol was decided by the French Drug Agency.

Methods: All Serious Adverse Drug Reactions (SADR) notified with tramadol to the French PharmacoVigilance Centres (CRPV) and pharmaceutical companies between August 1(st), 2010 and July 31(th), 2011 were analyzed.

[Not Available].

Objective: Tramadol is a weak opioid used as a step 2 analgesic, approved in France for moderate to severe pain. After dextropropoxyphene withdrawal, a national pharmacovigilance follow-up of tramadol was decided by the French Drug Agency.

Methods: All Serious Adverse Drug Reactions (SADR) notified with tramadol to the French PharmacoVigilance Centres (CRPV) and pharmaceutical companies between August 1(st), 2010 and July 31(th), 2011 were analyzed.