Revue des signaux générés par une méthode automatisée sur 3324 cas de pharmacovigilance

La détection automatisée du signal en pharmacovigilance permet d'attirer l'attention des experts sur des associations {médicament, effet indésirable} qui sont statistiquement significatives dans une base de données. Notre objectif était d'évaluer les signaux générés par une méthode automatisée sur les cas saisis dans le centre de pharmacovigilance de l'Hôpital Européen Georges Pompidou. Ces cas nous ont déjà permis de détecter plusieurs signaux en utilisant les méthodes classiques de la pharmacovigilance. Nous avons sélectionné 3324 cas de pharmacovigilance et appliqué le critère proposé par Evans et al. Cinq cent vingt-trois associations ont été mises en évidence parmi lesquelles 107 n'étaient pas décrites dans le résumé des caractéristiques du produit des médicaments concernés. La plupart des signaux potentiels étaient des faux positifs. Bien que la méthode de détection automatisée ait fourni peu d'informations supplémentaires par rapport aux signaux déjà détectés par des méthodes plus classiques, cette technique nous a permis de restreindre notre revue de cas à une portion très restreinte des données (9,6 %)

Vestibular disorders following BNT162b2 mRNA COVID-19 vaccination: A retrospective case series

International audienceBackground: There are few publications regarding manifestations of vestibular disorders (VDs) following BNT162b2 mRNA COVID-19 vaccination. Purpose: We describe cases of VD potentially related to BNT162b2 vaccination and calculate its reporting rate, in order to enlarge knowledge about this adverse effect. Methods: A retrospective analysis of cases of VD following BNT162b2 vaccination reported to the pharmacovigilance centre of Georges-Pompidou European Hospital (France), in 2021 was performed. In order to identify these cases from the pharmacovigilance database containing all our registered cases, we used the Standardised MedDRA Query (SMQ) ‘vestibular disorders’. Then we analysed cases with vestibular symptoms, based on the association of typical manifestations. The reporting rate was calculated based on the number of VD cases and the number of vaccinated patients. Results: Among 6608 cases reported to our centre related to COVID-19 vaccines during 2021, 34 VDs associated with BNT162b2 administration were included. They were mainly reported in females (79%), 62% occurred after the first dose and 32% were serious. Symptoms had completely resolved in 13 cases (38%). Vertigo was the most common symptom followed by balance disorders. Three patients received second dose without reappearance of VD. The final diagnosis was reported in 10 patients (six cases of vestibular neuritis, two cases of central VD, two cases of benign paroxysmal positional vertigo). The regional reporting rate was 26 [95% CI: 17–34] cases of VD per 1 million persons vaccinated. Conclusion: Although the relationship between vaccination and VD cannot be established, clinicians should be aware of this rare adverse effect

Detection of Drug–Drug Interactions Inducing Acute Kidney Injury by Electronic Health Records Mining

International audienceBackground and Objective : While risk of acute kidney injury (AKI) is a well documented adverse effect of some drugs, few studies have assessed the relationship between drug–drug interactions (DDIs) and AKI. Our objective was to develop an algorithm capable of detecting potential signals on this relationship by retrospectively mining data from electronic health records.Material and methods : Data were extracted from the clinical data warehouse (CDW) of the Hôpital Européen Georges Pompidou (HEGP). AKI was defined as the first level of the RIFLE criteria, that is, an increase ≥50 % of creatinine basis. Algorithm accuracy was tested on 20 single drugs, 10 nephrotoxic and 10 non-nephrotoxic. We then tested 45 pairs of non-nephrotoxic drugs, among the most prescribed at our hospital and representing distinct pharmacological classes for DDIs.Results : Sensitivity and specificity were 50 % [95 % confidence interval (CI) 23.66–76.34] and 90 % (95 % CI 59.58–98.21), respectively, for single drugs. Our algorithm confirmed a previously identified signal concerning clarithromycin and calcium-channel blockers (unadjusted odds ratio (ORu) 2.92; 95 % CI 1.11–7.69, p = 0.04). Among the 45 drug pairs investigated, we identified a signal concerning 55 patients in association with bromazepam and hydroxyzine (ORu 1.66; 95 % CI 1.23–2.23). This signal was not confirmed after a chart review. Even so, AKI and co-prescription were confirmed for 96 % (95 % CI 88–99) and 88 % (95 % CI 76–94) of these patients, respectively.Conclusion : Data mining techniques on CDW can foster the detection of adverse drug reactions when drugs are used alone or in combination

Amoxicillin‐induced crystal nephropathy: A nationwide French pharmacovigilance databases study

International audienceAims: Amoxicillin (AMX)-induced crystal nephropathy (AICN) is a rarely reported adverse drug reaction (ADR) but its increase has been recently reported in the Paris area. Our aim was to investigate the incidence, characteristics and outcome of AICN in France.Methods: Retrospective analysis of all AICN cases reported to the French National Pharmacovigilance Database and the Marketing Authorization Holders Pharmacovigilance Database. AICN notification rate was compared to intravenous AMX and AMX-clavulanate sales.Results: In total, 101 AICN cases were included. Intravenous AMX/AMX-clavulanate was prescribed as surgical prophylaxis (32 surgical patients) or to treat infection (69 medical patients). AKI KDIGO stage 3 was observed in 70 patients and 24/70 patients required renal replacement therapy and/or intensive care unit admission. The annual notification rate of AICN was increased by a factor of 13 since 2010 (6 [0;7] and 77 [24;111] cases per 100 000 patient-years of exposure, before and after 2010 respectively; P < .001). In surgical patients, the increase in AICN has been reported since 2010 and was mainly related to inadequate AMX administration. In medical patients, the increase in AICN was observed since 2014. After 2014, medical patients were older (67 [42;77] vs 74 years [64;84] respectively; P < .05) and were treated more frequently for endocarditis (0/20 vs 15/49 respectively; P < .01). A contributing factor was observed or suspected in 62 patients.Conclusion: AICN is a severe ADR that dramatically increased in France since 2010. Assessment of AICN contributing factors and AMX drug monitoring in patients receiving high dose of AMX could reduce the risk of AICN

Pigmentation cutanée liée à l’extravasation de fer injectable. Analyse de la base française de pharmacovigilance de 2000 à 2016

National audienc

Frequency and factors associated with infusion-related local complications of vancomycin on peripheral venous catheters

International audienceBACKGROUND: Vancomycin is a reference antibiotic against methicillin-resistant staphylococci. Its administration is associated with infusion-related local complications (IRLC). To reduce this risk, it has been proposed to increase vancomycin dilution in the IV bag and to perform continuous infusion using the volumetric pump. The aim of our study was to assess the safety of peripheral infusion of vancomycin with the volumetric pump. OBJECTIVES: To compare the frequency of IRLC between patients receiving vancomycin and those receiving β-lactam (BL) antibiotics. Our secondary objective was to assess factors associated with the occurrence of IRLC. PATIENTS AND METHODS: We conducted a prospective observational study in a French tertiary hospital. Between February 2021 and November 2021, we included all patients receiving continuous infusions of vancomycin or BL through a peripherally inserted venous catheter (PIVC). The primary endpoint was the occurrence of IRLC on Day 1 (D1). RESULTS: We included 168 patients (56 vancomycin, 112 BL). At D1, 14 patients (25%) presented IRLC in the vancomycin group versus 11 patients (10%) in the BL group (P = 0.01). There was significantly more IRLC in the group receiving vancomycin at an infused concentration above 5 mg/mL than those receiving BL (8/15, 53.3% versus 11/112, 10%, respectively, P < 0.01). However, no significant difference was observed between patients receiving infused vancomycin concentration ≤5 mg/mL and patients receiving BL (P = 0.4). CONCLUSION: Our data support safe administration of vancomycin if infused at a concentration under 5 mg/mL, through the volumetric pump on PIVC

Intramuscular Vaccination in Adults with Therapeutic Anticoagulation in the Era of COVID-19 Vaccines Outbreak: A Practical Review

International audienc