Ondansetron induced blindness: a pharmacovigilance database study.

Background: Ondansetron is an antiemetic drug (AED) used to prevent and treat nausea and vomiting. The summary of product characteristics reports a rare risk of transient blindness primarily during IV injections, notably with the concomitant use of chemotherapeutic agents. We aimed to refine the characterization of ondansetron-induced blindness.

Quality of reporting of adverse events in clinical trials of covid-19 drugs: systematic review.

Objective: To assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms extension and according to clinical trial design, and to examine reporting of serious adverse events in drug trials published on PubMed versus clinical trial summaries on ClinicalTrials.gov.

Design: Systematic review.

Sublingual/Buccal buprenorphine and dental problems: a pharmacovigilance study.

Background: The association between dental problems and sublingual/buccal buprenorphine is unclear. We conducted an analysis of dental adverse drug reactions reported with sublingual/buccal buprenorphine in VigiBase®, the pharmacovigilance database of the World Health Organization.

Research Design And Methods: We performed disproportionality analyses to compare the reporting rates of dental problems with sublingual/buccal buprenorphine, compared to other buprenorphine formulations and methadone.

Will artificial intelligence chatbots replace clinical pharmacologists? An exploratory study in clinical practice.

Purpose: Recently, there has been a growing interest in using ChatGPT for various applications in Medicine. We evaluated the interest of OpenAI chatbot (GPT 4.0) for drug information activities at Toulouse Pharmacovigilance Center.

Health care resource use and costs among patients with carcinoid syndrome in France: Analysis of the National Health Insurance Database.

Objectives: Carcinoid syndrome (CS) develops in approximately 20% of patients with neuroendocrine tumours (NET). This study described healthcare resource utilization and its associated costs among patients with NET and CS, using the French national health care data system.

Methods: Patients were included if they had a hospital stay associated with the code E34.

Drug-related catatonia in youths: real-world insights from the WHO Safety Database.

Catatonia is characterized by psychomotor alterations and reduced contact with the environment. Initially linked to schizophrenia, it also occurs in mood disorders or organic conditions. In children, catatonia remains poorly delineated, despite dramatically increasing the risk of premature death.

Efficacy and Safety of Eculizumab in Pediatric Patients Affected by Shiga Toxin-Related Hemolytic and Uremic Syndrome: A Randomized, Placebo-Controlled Trial.

Significance Statement: Shiga toxin-related hemolytic uremic syndrome (STEC-HUS) is a serious condition, characterized by multiorgan thrombotic microangiopathy, mainly affecting children. Renal involvement is severe, with approximately half of patients requiring dialysis. So far, no specific treatment has been proven efficient in STEC-HUS.

Optimizing therapeutic decision-making for off-label medicines use: A scoping review and consensus recommendations for improving practice and research.

Purpose: Off-label medicines use is a common and sometimes necessary practice in many populations, with important clinical, ethical and financial consequences, including potential unintended harm or lack of effectiveness. No internationally recognized guidelines exist to aid decision-makers in applying research evidence to inform off-label medicines use. We aimed to critically evaluate current evidence informing decision-making for off-label use and to develop consensus recommendations to improve future practice and research.

Hypofractionated Stereotactic Re-irradiation and Anti-PDL1 Durvalumab Combination in Recurrent Glioblastoma: STERIMGLI Phase I Results.

Background: Hypofractionated stereotactic radiotherapy (hFSRT) is a salvage option for recurrent glioblastoma (GB) which may synergize anti-PDL1 treatment. This phase I study evaluated the safety and the recommended phase II dose of anti-PDL1 durvalumab combined with hFSRT in patients with recurrent GB.

Methods: Patients were treated with 24 Gy, 8 Gy per fraction on days 1, 3, and 5 combined with the first 1500 mg Durvalumab dose on day 5, followed by infusions q4weeks until progression or for a maximum of 12 months.

Reporting of harms in clinical trials of esketamine in depression: a systematic review.

While previous systematic reviews of trials evaluating conventional antidepressants highlighted inadequacies and inconsistencies in adverse event (AE) reporting, no evaluation is available on esketamine in resistant depression. The objective of this review was to assess quality of reporting AEs in all published clinical trials studying esketamine. It also aimed to compare the proportions of AEs reported in journal articles to those recorded in the ClinicalTrial.

Safety Signal Generation for Sudden Sensorineural Hearing Loss Following Messenger RNA COVID-19 Vaccination: Postmarketing Surveillance Using the French Pharmacovigilance Spontaneous Reporting Database.

Background: The World Health Organization recently described sudden sensorineural hearing loss (SSNHL) as a possible adverse effect of COVID-19 vaccines. Recent discordant pharmacoepidemiologic studies invite robust clinical investigations of SSNHL after COVID-19 messenger RNA (mRNA) vaccines. This postmarketing surveillance study, overseen by French public health authorities, is the first to clinically document postvaccination SSNHL and examine the role of potential risk factors.

Drugs and the elderly: A complex interaction.

Although it can be difficult to define who should be considered an elderly person, the population aged 65 and over is experiencing the fastest demographic expansion and will represent almost one billion inhabitants of the 2030 World. Drug use increases dramatically with age and the elderly population is, by far, the highest consumer of medicines, up to 10 times more than younger adults. This consumption is in many aspects inappropriate, unjustified or sub-optimal and associated with a huge number of adverse reactions, admissions in emergency units and attributable deaths.

Testosterone treatment and the risk of osteonecrosis: a pharmacovigilance analysis in Vigibase.

Purpose: Recent reports have raised concerns about a potential risk of osteonecrosis associated with testosterone treatment (TT). The aim of this pharmacovigilance study was to assess the risk of reporting osteonecrosis associated with the use of TT compared with use of any other medication.

Methods: We performed a disproportionality analysis to investigate the risk of reporting osteonecrosis with TT using the WHO database VigiBase.

Comparative Effects of 30 Antipsychotics on Risk of Catatonia: An Analysis of the WHO Pharmacovigilance Database.

Catatonia is a life-threatening psychomotor syndrome that occurs in approximately 10% of patients with acute psychiatric illnesses. Although some case reports have argued that first generation antipsychotics (FGAs) are more likely to induce catatonia than second generation antipsychotics (SGAs), no large observational study has confirmed this hypothesis. We investigated whether FGAs were associated with an increased risk of reporting catatonia when compared with SGAs.

Antipsychotics and risk of QT prolongation: a pharmacovigilance study.

Rationale: While meta-analyses of clinical trials found that lurasidone and partial dopamine agonists (brexpiprazole and aripiprazole) were the antipsychotics less likely to cause QTc prolongation, and sertindole, amisulpride, and ziprasidone were the most frequently associated with this adverse drug reaction; no real-world studies have investigated this risk between the different antipsychotics.

Objectives And Methods: Using data recorded from 1967 to 2019 in VigiBase®, the World Health Organization's Global Individual Case Safety Reports database, we performed disproportionality analysis to investigate the risk of reporting QT prolongation between 20 antipsychotics.

Results: Sertindole had the highest risk of reporting QT prolongation, followed by ziprasidone and amisulpride.

Increased reporting of venous and arterial thromboembolic events reported with tixagevimab-cilgavimab for coronavirus disease 2019.

Objectives: As two phase three clinical trials indicated a disproportion in the number of thromboembolic events in the tixagevimab/cilgavimab group than in the placebo group, there has been a cardiovascular safety concern with the use of anti-SARS-CoV-2 monoclonal antibody (mAb). Whether tixagevimab/cilgavimab use in real life increases the risk of thromboembolic events is unclear.

Methods: We used VigiBase, WHO's individual case safety reports database, to assess the risk of reporting arterial or venous thromboembolic events in patients with COVID-19 (aged ≥12 years) exposed to tixagevimab/cilgavimab compared with patients with COVID-19 exposed to other anti-SARS-CoV-2 mAbs, including casirivimab/imdevimab, bamlanivimab/etesevimab and sotrovimab.

Weight Gain During Antipsychotic Treatment in Children, Adolescents, and Adults: A Disproportionality Analysis in the Global Pharmacovigilance Database, Vigibase.

Introduction: While antipsychotic-induced weight gain has been widely described in adults, it has yet to be better characterized in children and adolescents.

Objective: The aim of this study was to assess antipsychotic-induced weight-gain reporting in children and adolescents as compared to adults, and according to the type of antipsychotic.

Methods: The study is an observational, case-non-case study using individual case safety reports from the WHO global pharmacovigilance database VigiBase from 1 January 2000 to 2 June 2021.