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.

Immediate allergies to chlorhexidine: A series of pediatric cases from the French pharmacovigilance database: Immediate allergies to chlorhexidine: series of pediatric cases from the French pharmacovigilance database.

Background: Immediate allergic reactions to chlorhexidine have been clearly identified in numerous countries, generating governmental warnings worldwide.

Objectives: The aim of our study was to characterize (i) these allergies, which are less reported in pediatric populations, and (ii) the patient-at-risk profile so as to suggest preventive measures.

Methods: In association with the allergy department and the regional pharmacovigilance center in Rennes University Hospital, France, a multicenter retrospective, descriptive, and observational study was conducted using data from the national pharmacovigilance database for the period of January 1, 2010 to June 30, 2020.

[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).

Osteonecrosis of the jaw under palbociclib: A case series description.

Introduction: Cases of osteonecrosis of the jaw have been reported by dental surgeons to the pharmacovigilance center in Rennes, France, occurring among patients treated with palbociclib, a cyclin-dependent kinase 4/6 inhibitor. Although this event was not expected with the drug, a safety signal was raised. Describing a local case series, the aim of our study was to identify specific patterns that might suggest a triggering role for these drugs, and to discuss pathophysiological hypotheses.

Incidence and preventability of hospital admissions for adverse drug reactions in France: A prospective observational study (IATROSTAT).

Aims: In the last French study in 2007, the incidence of hospital admissions (HAs) related to adverse drug reactions (ADRs) was 3.6%. The objective was to assess the current ADR-HA incidence in France and to describe both its characteristics and preventability.

Assessing the Risk of Relapse Requiring Corticosteroids After In Vitro Fertilization in Women With Multiple Sclerosis.

Background And Objectives: Several studies have shown an increased risk of relapse after in vitro fertilization (IVF) in women with multiple sclerosis (MS), especially when a gonadotrophin-releasing hormone (GnRH) agonist stimulation protocol was used. Our objective was to investigate the risk of relapse after IVF in women with MS, overall and according to stimulation protocol (GnRH agonists vs antagonists), using data from the French national health insurance database.

Methods: This retrospective cohort study included all women with MS who have benefited from IVF between January 1, 2010, and December 31, 2015, in France.

Management of drug-drug interactions with nirmatrelvir/ritonavir in patients treated for Covid-19: Guidelines from the French Society of Pharmacology and Therapeutics (SFPT).

Objectives: Nirmatrelvir in association with ritonavir (PAXLOVID™, Pfizer) is an antiviral agent targeting the 3-chymotrypsin-like cysteine protease enzyme (3C-like protease or Mpro) which is a key enzyme of the viral cycle of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This combination with a well-known pharmacokinetic enhancer leads to a high risk for drug-drug interactions in a polymedicated elected population for treatment. The aim of this work was to provide recommendations on behalf of the national French society of pharmacology (French Society of Pharmacology and Therapeutics; SFPT), by suggesting optimal and pragmatic therapeutic strategies if nirmatrelvir/ritonavir is to be given together with drugs commonly used, in order to ensure secured physicians' prescription.

SARS-CoV-2 and spp.: friend or foe? A systematic literature review.

During this global pandemic of the COVID-19 disease, a lot of information has arisen in the media and online without scientific validation, and among these is the possibility that this disease could be aggravated by a secondary bacterial infection such as as well as the interest or not in using azithromycin, a potentially active antimicrobial agent. The aim of this study was to carry out a systematic literature review, to prove or disprove these allegations by scientific arguments. The search included Medline, PubMed, and Pubtator Central databases for English-language articles published 1999-2021.

Prescribing Trends for Valproate Among Pregnant Women: A Cross-sectional Study in 2013 and 2016 Using the French Health Insurance Database.

Background And Objective: To describe the prescribing trends for sodium valproate (VPA) and alternative drugs during and around pregnancy, comparing 2016 (after the recommendations on valproate for women were reinforced by the European Medicines Agency [EMA]) with 2013 (before the recommendations).

Methods: Using the French National Health Insurance Database, a cross-sectional study was carried out in 2013 and in 2016, including women who became pregnant and had at least 1 reimbursement claim for VPA in the 2 years prior to pregnancy or during pregnancy. Exposure to VPA and its alternatives was then measured for each quarter, in the 2 years before pregnancy (preconception), during pregnancy, and in the year after pregnancy (postpartum).

Impact of recommendations on sodium valproate prescription among women with epilepsy: An interrupted time-series study.

Background: The European Medicines Agency (EMA) has developed risk minimization measures (RMMs) to reduce the use of the teratogenic drug, sodium valproate (VPA). The objective was to assess the impact of these RMMs among females with epilepsy in France.

Methods: We used data from the French National Health Insurance Database (SNDS), including 114,936 females aged under 50, with a reimbursement claim for an antiepileptic drug from January 2011 to December 2017, and identified as people with epilepsy.

[Side effects of longterm oral corticosteroid therapy].

Side effects of long-term oral corticosteroid therapy. Systemic corticosteroid therapy has been used for over 70 years, and is still the cornerstone of the treatment of many conditions, in particular systemic, autoimmune or inflammatory diseases. Side effects of corticosteroids are numerous, and for most of them well known by prescribers.

Pregnancy in women with multiple sclerosis in France from 2010 to 2015: Incidence, outcomes, and exposure to disease-modifying therapies.

Background: Multiple sclerosis (MS) is usually diagnosed between 20-40 years old, when women often plan to have children.

Objective: Our objectives were to estimate pregnancy incidence rates in women with multiple sclerosis (MS), and to describe the use of disease-modifying therapies (DMTs) before conception and during pregnancy, and pregnancy outcomes.

Methods: This retrospective cohort study included all 15- to 49-year-old women with MS in the French national health insurance database over 2010-2015.

REview of potentially inappropriate MEDIcation pr[e]scribing in Seniors (REMEDI[e]S): French implicit and explicit criteria.

Purpose: To establish a consensus on both explicit and implicit criteria in order to identify potentially inappropriate prescribing (PIP) in French older people aged 75 years and over or 65 years and over with multimorbidity.

Methods: Fifteen experts in geriatrics, general practice, pharmacy, and clinical pharmacology were involved in a two-round Delphi survey to assess preliminary explicit and implicit criteria based on an extensive literature review and up-to-date evidence data. Experts were asked to rate their level of agreement using a 5-level Likert scale for inclusion of criteria and also for rationale and therapeutic alternatives.

COVID-19 vaccine hesitancy among healthcare workers.

Objective: To characterize healthcare workers' (HCWs) intention to receive the COVID-19 vaccine by the beginning of the vaccine campaign in France.

Methods: Data were collected on a self-administered questionnaire through the website of a tertiary care center (February 9-18, 2021).

Results: Among 1,965 respondents, 1,436 (73.

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.

Analysis of the association between emergency dialysis start in patients with end-stage kidney disease and non-steroidal anti-inflammatory drugs, proton-pump inhibitors, and iodinated contrast agents.

Background: The association between the use of potentially nephrotoxic drugs [Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Iodinated Contrast Agents, Proton Pump Inhibitors (PPIs)] and emergency start of dialysis in patients with chronic kidney disease has not been well explored, although these compounds are commonly prescribed or available without prescription.

Methods: In this study, the Renal Epidemiology Information Network (REIN) registry data of all patients ≥ 18 years of age who started dialysis in France in 2015 were matched with those in the French National Health Insurance Database. The association between clinical characteristics, nephrotoxic drug exposure and emergency dialysis start was investigated.

Association of Antihypertensive Agents with the Risk of In-Hospital Death in Patients with Covid-19.

Purpose: The role of angiotensin receptor blockers (ARB), angiotensin-converting enzyme inhibitors (ACEi), or other antihypertensive agents in the case of Covid-19 remains controversial. We aimed to investigate the association between antihypertensive agent exposure and in-hospital mortality in patients with Covid-19.

Methods: We performed a retrospective multicenter cohort study on patients hospitalized between February 1 and May 15, 2020.

[Adverse drug reactions profiles for abiraterone and enzalutamide: A pharmacovigilance descriptive analysis].

Objective: The aim of this study was to describe the profile of adverse drug reactions (ADRs) observed with abiraterone and enzalutamide, based on cases registered in the French regional pharmacovigilance centres to identify potential pharmacovigilance signals.

Methods: We extracted from the French pharmacovigilance database all cases of ADRs or drug interactions involving abiraterone or enzalutamide from the time they market authorization date until December 31st, 2017. Signal detection results have been transmitted by the French Agency for Health Products (ANSM).

Teriflunomide-exposed pregnancies in a French cohort of patients with multiple sclerosis.

Objective: To describe pregnancies exposed to teriflunomide (TERIF) in women with multiple sclerosis (MS) in France over the period 2014-2016.

Methods: All 15- to 49-year-old women with MS in the national health insurance database were included. Pregnancies that had started between August 2014 and March 2016 were identified from their outcomes.