789 results match your criteria: "Centre Regional de PharmacoVigilance[Affiliation]"

Personalized Amoxicillin Therapy in a Critically Ill Patient Undergoing Renal Replacement Therapy: A Grand Round.

Ther Drug Monit

October 2024

Médecine Intensive Réanimation G, CHU de Saint-Etienne, Saint Etienne, France ; and.

Background: The case study discusses a complex scenario involving the use of amoxicillin in a critically ill patient undergoing intermittent renal replacement therapy.Severe infections are complicated by septic shock and organ failure, requiring urgent and effective antibiotic treatment.

Methods: The patient's comorbidities, including obesity and acute kidney injury, required careful consideration of the amoxicillin dosing strategies.

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Introduction: Drug efficacy and effectiveness are assessed respectively through clinical trials and pharmaco-epidemiological studies. However, relative and absolute benefits of drugs are distinct measures that must be considered in relation to the baseline risk of disease incidence, complication or progression. On the other hand, adverse drug reactions are independent of the basic risk but depend on the characteristics of the population treated.

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Objectives: Dihydropyrimidine dehydrogenase (DPD) deficiency is the main cause of severe fluoropyrimidine-related toxicities. The best strategy for identifying DPD-deficient patients is still not defined. The EMA recommends targeted genotyping or uracilemia (U) testing.

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Isotretinoin: Past, present and future. A French perspective.

Ann Dermatol Venereol

September 2024

Centre de Preuves de la Société Française de Dermatologie, 10 Cité Malesherbes, 75009 Paris, France; Groupe DEFI de la Société Française de Dermatologie, 10 Cité Malesherbes, 75009 Paris, France; Consultation dermatoses faciales, AP-HP, Hôpital Universitaire Pitié-Salpêtrière, 75013 Paris, France.

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Article Synopsis
  • Epidermal necrolysis (EN) includes severe conditions like Stevens-Johnson syndrome and is primarily drug-induced, with notable differences in incidence and outcomes between children and adults.
  • A study analyzed data from the French Health System to compare EN cases in both demographics, examining incidence, suspected drug exposure, and mortality rates.
  • Results showed that EN is less common in children (1.5 cases/million) compared to adults (2.6 cases/million), with children having a lower rate of drug exposure before onset and significantly lower mortality (1.4% vs. 19.4%).
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Use of methylphenidate and reporting of valvular heart disease: Global pharmacovigilance analysis in children and adults.

Pharmacoepidemiol Drug Saf

June 2024

URP7323 « Pharmacologie et évaluation des thérapeutiques chez l'enfant et la femme enceinte », Université Paris Cité, Paris, France.

Introduction: Methylphenidate (MPH) is a common treatment of attention-deficit/hyperactivity disorder (ADHD). Concern has been raised regarding its cardiovascular safety, partly in relation with its micromolar affinity for the 5-HT receptor, whose activation may result in valvular heart disease (VHD).

Methods: To explore the association between the use of MPH and VHD reporting, we performed a disproportionality analysis within the WHO global safety database (VigiBase) using data, since inception until March 6th 2024, from: (i) the full database and (ii) different age groups (children/adolescents 6-17 years; adults 18-64 years).

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Polypharmacy, drug-drug interactions, and adverse drug reactions among systemic sclerosis patients: A cross-sectional risk factor study.

Semin Arthritis Rheum

August 2024

Service de Médecine Interne, Centre de Référence Maladies Systémiques Autoimmunes et Autoinflammatoires Rares d'Ile de France, de l'Est et de l'Ouest, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris (AP-HP); APHP-CUP, Hôpital Cochin, Université Paris Cité, F-75014, Paris. Electronic address:

Objectives: Polypharmacy, drug-drug interactions (DDI) and related adverse drug reaction (ADR) are understudied in SSc. The aim of this work was to determine the prevalence and determinants of DDI and ADR in a real-life prospective cohort of SSc patients.

Methods: We performed a retrospective analysis of the drug prescriptions of SSc patients admitted to the daily scleroderma clinic between January 2020 and April 2022.

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Background: Despite the French pregnancy prevention program (PPP), a considerable number of pregnancies are potentially exposed to oral isotretinoin. New measures were taken by the French Medicines Agency, including the restriction of initial isotretinoin prescriptions to dermatology specialists in May 2015 and a new information campaign on teratogenicity in January 2019.

Objectives: The aims were to: describe, between 2014 and 2021, compliance with PPP recommendations: isotretinoin use as a second-line treatment, first prescription by a dermatology specialist, monthly prescription renewal and pregnancy testing (PT); assess the effect of the 2015 and 2019 measures on PT compliance; and identify the determinants of PT noncompliance.

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Hypothermia in patients with cardiac arrest prior to ECMO-VA: Insight from the HYPO-ECMO trial.

Resuscitation

July 2024

Université de Lorraine, INSERM, Centre d'Investigations Cliniques Plurithématique, INSERM 1433, CHRU de Nancy, Institut Lorrain du Coeur et des Vaisseaux, Nancy, France; INI-CRCT (Cardiovascular and Renal Clinical Trialists), F-CRIN Network, Nancy, France; REICATRA, Université de Lorraine, Nancy, France.

Article Synopsis
  • The HYPO-ECMO trial evaluated the effects of moderate hypothermia (MH) versus normothermia in patients with cardiogenic shock (CS) and cardiac arrest (CA) treated with venoarterial extracorporeal membrane oxygenation (VA-ECMO).
  • The study analyzed data from 334 intubated patients and found that 48% had experienced CA; mortality rates were higher in the CA group compared to those without CA.
  • Results indicated that MH significantly reduced mortality and improved outcomes for patients with CA, suggesting its potential benefit in this high-risk subgroup, though further research is required for confirmation.
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Drug-drug interaction and inadequate exposure to voriconazole in critically ill patients with multiple organ failure: A pediatric case study.

Therapie

April 2024

Service de réanimation et surveillance continue médicochirurgicales pédiatrique, hôpital Necker-Enfants-Malades, AP-HP, Université Paris Cité, 75000 Paris, France. Electronic address:

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Association between direct acting agents used for chronic hepatitis C virus infection and the occurrence of acute leukaemia - A disproportionality analysis.

Clin Res Hepatol Gastroenterol

June 2024

Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié Salpêtrière, Département de Santé Publique, Centre de Pharmaco épidémiologie (Cephepi), F75013, Paris, France. Electronic address:

Background And Aims: A recent single-center study reported a significant increase in acute myeloid leukaemia (AML) cases, including mixed-phenotype acute leukaemia (MPAL), after exposure to direct acting agents (DAA). We investigated whether DAA use increased the risk of AML in patients with chronic hepatitis C virus (HCV) infection.

Methods: We conducted a disproportionality analysis of the WHO Pharmacovigilance database Vigibase up to 2020.

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Triptan use in elderly over 65 years and the risk of hospitalization for serious vascular events.

J Headache Pain

April 2024

service de pharmacologie clinique & pharmacosurveillance, centre régional de pharmacovigilance, Aix-Marseille université, Inserm, UMR 1106, Assistance publique-Hôpitaux de Marseille, Hopital Sainte Marguerite 270, boulevard sainte Marguerite, Marseille, 13009, France.

Background: Several studies have focused on the use of triptan and the risk of acute vascular events but the existence of such association is still debated and has never been quantified in patients over 65 years. To assess whether triptan use among older is associated with an increased risk of hospitalization for acute vascular events.

Methods: A propensity score-matched cohort study was designed using the French national health insurance database linked to hospital stays.

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Cefotaxime administration is recommended in doses of 3-12 g/day in adults with a Glomerular Filtration Rate (GFR) > 5 mL/min. This study aimed to assess the impact of renal function and obesity on cefotaxime concentrations in intensive care unit (ICU) patients. A retrospective cohort study was conducted on consecutive ICU patients receiving continuous cefotaxime infusion between 2020 and 2022 [IRBN992021/CHUSTE].

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Profile of adverse drug reactions reported via the Continuum+ platform: Results from three-year regional follow-up.

Therapie

November 2024

Centre régional de pharmacovigilance, laboratoire de pharmacologie-toxicologie et centre d'évaluation et d'information sur la pharmacodépendance-addictovigilance de Nancy, centre hospitalier régional et universitaire de Nancy-Brabois, rue du Morvan, 54511 Vandœuvre-lès-Nancy, France; Centre national de la recherche scientifique, IMOPA, université de Lorraine, 54000 Nancy, France.

In 2017, the Continuum+ platform was launched to provide a monitoring solution to home-based cancer care patients: AKO@dom monitoring. This platform also offers the follow-up of adverse drug reactions (ADRs) via direct notification to regional centers of pharmacovigilance (RCPVs). According to previous studies, the AKO@dom monitoring has successfully maintained treatment at the maximum effective dosage, managing ADRs and patient satisfaction.

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Objectives: Drug shortages are of increasing concern to worldwide public health. The consequences of drug shortages for patient safety have been little studied, especially from a pharmacovigilance point of view. In this context, the network of French pharmacovigilance centres conducted the CIRUPT study (Conséquences Iatrogènes des RUPTures de stock/iatrogenic consequences of drug shortages) based on a prospective campaign of adverse effects occurring in the context of drug shortage notifications.

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[Palmar aquagenic keratoderma secondary to treatment of chronic osteitis with tedizolide: A case report].

Therapie

April 2024

Département de maladies infectieuses, CH Gustave-Dron, 59200 Tourcoing, France; EA 2694 - Santé publique : épidémiologie et qualité des soins, université de Lille, 59000 Lille, France.

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We conducted a national in-depth analysis including pharmacovigilance reports and clinical study to assess the reporting rate (RR) and to determine the clinical profile of polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) in COVID-19-vaccinated individuals. First, based on the French pharmacovigilance database, we estimated the RR of PMR and GCA cases in individuals aged over 50 who developed their initial symptoms within one month of receiving the BNT162b2 mRNA, mRNA-1273, ChAdOx1 nCoV-19, and Ad26.COV2.

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Introduction: Bariatric surgery is the only treatment for severe obesity (BMI>35kg/m) currently recognized as effective both in achieving tangible and lasting weight loss, and in improving obesity-related comorbidities such as type 2 diabetes, hypertension, and cardiovascular complications. Bariatric surgery, like any other surgery of the digestive tract, can have an impact on nutrient absorption, as well as on drug absorption. The literature on drug management in bariatric surgery patients concerned mainly of case reports and retrospective studies involving a small number of patients.

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In Utero Exposure to Antibiotics and Risk of Serious Infections in the First Year of Life.

Drug Saf

May 2024

Centre Régional de Pharmacovigilance, Service de Pharmacologie périnatale, pédiatrique et adulte, Hopital Cochin, Assistance Publique-Hopitaux de Paris (AP-HP), 27, rue du Faubourg Saint Jacques, 75014, Paris, France.

Introduction And Objective: Given the high prevalence of antibiotic prescription during pregnancy in France and previous studies suggesting an increased risk of infection in offspring with such exposures, our study aimed to investigate the association between prenatal exposure to systemic antibiotics and serious infections in full-term infants during their first year of life.

Methods: We conducted a retrospective population-based cohort study on singleton, full-term liveborn non-immunocompromised infants, using the French National Health Data System (SNDS) between 2012 and 2021. Systemic antibiotic dispensing in ambulatory care settings during pregnancy defined the exposure.

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