Adverse myocardial and vascular side effects of immune checkpoint inhibitors: a prospective multimodal cardiovascular assessment.

Background: Immune checkpoint inhibitors (ICIs) can induce cardiovascular toxicities.

Objectives: To prospectively assess the incidence of major cardiovascular events (MACE) on ICIs in solid cancer patients: myocarditis, pericarditis, acute coronary syndrome, heart failure, high-degree conduction abnormalities or sustained ventricular arrhythmias, or cardiovascular death at 6 weeks (early MACE), including asymptomatic clinical changes by an independent adjudication committee using current recommended diagnostic criteria. The secondary objective was the incidence of the above-mentioned events adding atrial fibrillation (AF) at 6 months (late MACE).

Heparin-induced thrombocytopenia in newborns: experience at a pediatric hospital and a literature review.

Background: Heparin-induced thrombocytopenia (HIT) is a rare, difficult-to-diagnose, and potentially serious adverse drug reaction with thrombotic complications. Even though the immune system is still immature during the neonatal period, HIT has been described in newborns with reporting rates ranging from 0% to 2.3%.

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

Background: 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.

Adverse drugs reactions (ADR) suspected through phone triage and assessed by medically staffed ambulances: A pilot study.

Background: Prompt and definitive diagnosis of adverse drug reactions (ADRs) is a challenge for health care providers. There is a global burden of ADRs worldwide associated with a negative impact on the patient's health, in parallel with increasing costs for the community. This study aims to determine the annual incidence of ADRs in the cohort of patients requiring immediate intervention of the French prehospital emergency medical service (PEMS).

Direct Oral Anticoagulants as Successful Treatment of Heparin-Induced Thrombocytopenia: A Parisian Retrospective Case Series.

Heparin-induced thrombocytopenia (HIT) is a prothrombotic life-threatening disorder caused by an adverse reaction to heparin exposure. In this context, it is imperative to stop heparin immediately and to replace it by a non-heparin anticoagulant therapy. Despite their advantages, the use of direct oral anticoagulants (DOACs) is only emerging for HIT treatment, and their use remains rare.

Heparin-induced thrombocytopenia: Construction of a pretest diagnostic score derived from the analysis of a prospective multinational database, with internal validation.

Background: Diagnosis of heparin-induced thrombocytopenia (HIT) requires pretest probability assessment and dedicated laboratory assays.

Objective: To develop a pretest score for HIT.

Design: Observational; analysis of prospectively collected data of hospitalized patients suspected with HIT (ClinicalTrials.

Vaccination against COVID-19: insight from arterial and venous thrombosis occurrence using data from VigiBase.

https://bit.ly/3mZqguE

Delayed thrombocytopenia following administration of abciximab: Pharmacovigilance survey and literature review.

Background: Abciximab (ABX) is used for acute coronary syndrome and unstable angina. Thrombocytopenia is a frequent adverse effect described as occurring in the first 24hours. The aim of this study was to evaluate, in a context of pharmacovigilance survey, the occurrence of delayed thrombocytopenia following ABX infusion in pharmacovigilance database reports and in the literature.

Dabigatran Level Before Reversal Can Predict Hemostatic Effectiveness of Idarucizumab in a Real-World Setting.

Idarucizumab has been included in guidelines for the management of bleeding or surgical procedure in dabigatran-treated patients without need for biological monitoring. The aim of the study was to assess the prognostic value of dabigatran plasma level before reversal to test the hemostatic efficacy of idarucizumab. The secondary objectives were (i) to analyze plasma dabigatran level according to the risk of rebound and (ii) to evaluate the incidence of post-reversal non-favorable clinical outcomes (including thromboembolism, bleeding, antithrombotic, and death) and antithrombotic resumption.

Acute Digital Ischemia After Arterial Injection of Crushed Zolpidem Tablets: Role of Microcrystalline Cellulose? A Case Report.

Literature is scarce on acute ischemia after intra-arterial injection of crushed tablets and no effective medical treatment against the progression of lesions is reported. The only factor able to modify the outcome is the delay between injection and management by a specialized vascular team. Moreover the risk of necrosis seems higher after benzodiazepine intra-arterial injection than with other drugs.

How to interact with medical terminologies? Formative usability evaluations comparing three approaches for supporting the use of MedDRA by pharmacovigilance specialists.

Background: Medical terminologies are commonly used in medicine. For instance, to answer a pharmacovigilance question, pharmacovigilance specialists (PVS) search in a pharmacovigilance database for reports in relation to a given drug. To do that, they first need to identify all MedDRA terms that might have been used to code an adverse reaction in the database, but terms may be numerous and difficult to select as they may belong to different parts of the hierarchy.

Discrepancy Between Personal Experience and Negative Opinion with Human Papillomavirus Vaccine in Web Forums.

While vaccines are intended to protect people from infectious diseases, public confidence in vaccination has evolved as patients have reservation about vaccination, with a major concern about its safety. Social media may help regulatory authorities to better understand opposition to vaccination and make informed decisions for better promotion of vaccines' benefits towards the public. Our objective was to explore French web forums for potential pharmacovigilance signals associated with human papillomavirus infections (HPV) vaccines.

Use of Social Media for Pharmacovigilance Activities: Key Findings and Recommendations from the Vigi4Med Project.

The large-scale use of social media by the population has gained the attention of stakeholders and researchers in various fields. In the domain of pharmacovigilance, this new resource was initially considered as an opportunity to overcome underreporting and monitor the safety of drugs in real time in close connection with patients. Research is still required to overcome technical challenges related to data extraction, annotation, and filtering, and there is not yet a clear consensus concerning the systematic exploration and use of social media in pharmacovigilance.

Toxicological Analysis Unveiling the Low Rate of Self-Reporting of Addictive/Recreative Substances in Acute Severe Drug Overdose Cases.

Objective: Toxicological analysis (TA) is advised when assessing the prognosis and the treatment of drug overdose patients. Apart from this use, the value of TA has remained unclear. This study aimed at defining the value of TA regarding the toxicological diagnosis in severe overdose cases that involved addictive or recreational drugs (ARDs) that were used either alone or in combination with medicinal drugs.

5-Fluorouracil-induced hyperammonaemic encephalopathy: A French national survey.

Background: 5-Fluorouracil (5-FU)-induced hyperammonaemic encephalopathy is a rare but serious 5-FU adverse drug reaction (ADR). Given the growing number of cancers treated with 5-FU and the paucity of data regarding this ADR, we performed a retrospective national survey to better characterise 5-FU-induced hyperammonaemic encephalopathy.

Patients And Methods: Since inception of the French pharmacovigilance database, we identified all patients who experienced 5-FU-induced hyperammonaemic encephalopathy.

Pharmacology and social media: Potentials and biases of web forums for drug mention analysis-case study of France.

The aim of this study is to analyze drug mentions in web forums to evaluate the utility of this data source for drug post-marketing studies. We automatically annotated over 60 million posts extracted from 21 French web forums. Drug mentions detected in this corpus were matched to drug names in a French drug database (Theriaque).

Secondary Stroke Prevention: A Population-Based Cohort Study on Anticoagulation and Antiplatelet Treatments, and the Risk of Death or Recurrence.

Using claims databases of a public healthcare program (Quebec) for the years 2010-2013, we conducted a cohort study of patients with acute ischemic stroke (AIS) to describe secondary prevention treatments and determine how they stood against practice guidelines. We compared the risk of death or AIS recurrence over 1 year in patients treated with anticoagulants, antiplatelets, and/or other cardiovascular drugs. In the month after discharge, 44.

Qualitative and Quantitative Analysis of Web Forums for Adverse Events Detection: "Strontium Ranelate" Case Study.

Social media are proposed as a complementary data source for detection and characterisation of adverse drug reactions. While signal detection algorithms were implemented for generating signals in pharmacovigilance databases, the implementation of a graphical user interface supporting the selection and display of algorithms' results is not documented in the medical literature. Although collecting information on the chronology and the impact of adverse drug reactions is desirable to enable causality and quality assessment of potential signals detected in patients' posts, no tool has been proposed yet to consider such data.

An Iconic Approach to the Browsing of Medical Terminologies.

Medical terminologies are the basis of interoperability in medicine. They allow connecting the various systems and data and facilitate searches in databases. An example is the MedDRA terminology, used in particular for coding drug adverse events.

Initial Experiments for Pharmacovigilance Analysis in Social Media Using Summaries of Product Characteristics.

We report initial experiments for analyzing social media through an NLP annotation tool on web posts about medications of current interests (baclofen, levothyroxine and vaccines) and summaries of product characteristics (SPCs). We conducted supervised experiments on a subset of messages annotated by experts according to positive or negative misuse; results ranged from 0.62 to 0.

[Informativity of French web forums for the evaluation of side effects of baclofen].

Objective: To evaluate the informativity, quality of French discussion forums for evaluation of baclofen safety.

Methods: We evaluated the quality of potential pharmacovigilance case reports associated to baclofen in 22 French discussion forums. We compared the informativity concerning the patient, treatment, seriousness and expectedness of adverse events described on these posts, with similar information coded in case reports from the French pharmacovigilance database (FPVD).