Reversible cerebral vasoconstriction syndrome in a methylphenidate-treated patient: a case report.

Background: Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by severe headaches, often thunderclap headaches, and a multifocal constriction of the cerebral arteries. Although RCVS can occur spontaneously, some cases occur after exposure to drugs. We describe the first case of RCVS in which methylphenidate, a drug with vasoconstrictive properties, is the only suspected drug.

[Adverse effects of the tezacaftor/ivacaftor/elexacaftor combination that may lead to discontinuation: About a series of 10 cases].

Introduction: Cystic fibrosis transmembrane regulator (CFTR) channel modulators (ivacaftor, lumacaftor, tezacaftor and elexacaftor) represent a major advance in the management of cystic fibrosis. However, few data are available on the real-life safety profile of these medications, in particular on adverse events that may lead to their discontinuation. The aim of this study is to describe the characteristics and evolution of adverse reactions to the tezacaftor/ivacaftor/elexacaftor combination that led to discontinuation and were reported to the Centre régional de pharmacovigilance (CRPV) in Rennes (France).

Reality of drug-induced erythema multiforme: A French pharmacovigilance study.

Background: Since the 2002 SCAR study, erythema multiforme (EM), a post-infectious disease, has been distinguished from Stevens-Johnson syndrome (SJS), drug-induced. Nevertheless, EM cases are still reported in the French pharmacovigilance database (FPDB).

Objectives: To describe EM reported in the FPDB and to compare the quality and the characteristics of the reports.

The Trigger Tool Method for Routine Pharmacovigilance: A Retrospective Cohort Study of the Medical Records of Hospitalized Geriatric Patients.

Objective: The main objective was to assess the feasibility of the trigger tool method for the retrospective detection of adverse drug reactions (ADRs) in the Rennes University Hospital. The secondary objective was to describe the performance of the method in terms of positive predictive values (PPVs) and severity or preventability of ADRs.

Methods: Using the Rennes University Hospital clinical data warehouse, pharmacovigilance experts performed a retrospective review of a random sample of 30 inpatient hospital medical records per month using the triggers "fall" and "delirium" to identify related ADRs among patients 65 years and older in 2018 in the geriatrics department.

Reversible anti-TNFα treatment induced dementia: A case report.

We report the first case of a reversible rapidly progressive dementia occurring in a patient with ankylosing spondylitis, a few months after the beginning of a TNFα inhibitor treatment (TNFi). The exhaustive neurologic explorations were negative. No etiology was found to explain dementia.

Hospital databases for the identification of adverse drug reactions: A 2-year multicentre study in 9 French general hospitals.

Aims: To estimate the actual number of adverse drug reactions (ADRs), we used the French medical administrative database (PMSI) in addition to ADRs spontaneously reported in the French Pharmacovigilance Database (FPVDB).

Methods: Capture-recapture method was applied to these 2 sources (PMSI and FPVDB), checking their independence via a third data source. The study ran from 1 July 2014 to 30 June 2016 in 9 French general hospitals.

[Pitch perception modification due to antiepileptics: A literature and pharmacovigilance databases review].

Pitch perception modifications are among the little-known adverse effects observed with antiepileptics, mainly affecting patients treated with carbamazepine (CBZ). Here, we describe an original French case of pitch perception modification due to CBZ resulting in perfect pitch loss. We also reviewed the literature as well as French and world health organisation global pharmacovigilance database.

Photodermatitis from topical phenothiazines: A case series.

Background: In Europe, contact photosensitivity to phenothiazines is well-known, particularly in southern countries. Topical phenothiazines are widely used and sold over-the-counter (OTC) for the treatment of mosquito bites and pruritus in France.

Objective: To report a series of cases with photodermatitis following use of topical phenothiazines.

Drug safety and big clinical data: Detection of drug-induced anaphylactic shock events.

Rationale, Aims, And Objectives: The spontaneous reporting system currently used in pharmacovigilance is not sufficiently exhaustive to detect all adverse drug reactions (ADRs). With the widespread use of electronic health records, biomedical data collected during the clinical care process can be reused and analysed to better detect ADRs. The aim of this study was to assess whether querying a Clinical Data Warehouse (CDW) could increase the detection of drug-induced anaphylaxis.

[Peranesthesic Anaphylactic Shocks: Contribution of a Clinical Data Warehouse].

Aim: To evaluate the performance of the collection of cases of anaphylactic shock during anesthesia in the Regional Pharmacovigilance Center of Rennes and the contribution of a query in the biomedical data warehouse of the French University Hospital of Rennes in 2009.

Methods: Different sources were evaluated: the French pharmacovigilance database (including spontaneous reports and reports from a query in the database of the programme de médicalisation des systèmes d'information [PMSI]), records of patients seen in allergo-anesthesia (source considered as comprehensive as possible) and a query in the data warehouse.

Results: Analysis of allergo-anesthesia records detected all cases identified by other methods, as well as two other cases (nine cases in total).

[Use of the PMSI for the detection of adverse drug reactions].

Aim: To evaluate the performance of a query on international classification of diseases 10(th) version (ICD10) codes in the database of the programme for the medicalisation of information systems (programme de médicalisation des systèmes d'information, PMSI) to identify serious adverse drug reactions (ADR).

Methods: The query concerned hospital stays of patients discharged from the French University Hospital of Rennes in 2009. All the hospitalization summaries including a selected ICD10 code were analysed to validate ADR.