PDL1 inhibitors may be associated with a lower risk of allograft rejection than PD1 and CTLA4 inhibitors: analysis of the WHO pharmacovigilance database.

Background: Transplant recipients face increased cancer mortality due to immunosuppressive treatments. Immune checkpoint inhibitors (ICI) have improved survival rates, but data on the use of these agents in transplant recipients is scarce. ICI may trigger allograft rejection, but the absolute risk of AR between the different ICI classes remains to be defined.

Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database.

Introduction: Improving adverse events following immunisation (AEFI) detection is vital for vaccine safety surveillance, as an early safety signal can help minimize risks. In February 2022, the World Health Organization reported a preliminary signal on sudden sensorineural hearing loss (SSNHL) following coronavirus disease 2019 (COVID-19) vaccination, 54 million persons in France received at least one dose, covering 78.8% of the population within a year.

Teprotumumab for the Treatment of Thyroid Eye Disease: Why Should We Keep Our Eyes "Wide Open"?-A Clinical and Pharmacovigilance Point of View.

Thyroid eye disease (TED) treatment has been recently revolutionized with the approval of teprotumumab, a targeted insulin growth factor 1 receptor (IGF1R) inhibitor. To date, teprotumumab is the only FDA-approved drug for treating TED. In this article, we would like to temper the current enthusiasm around IGF1R inhibitors.

Lipschütz ulcer following first dose of COVID-19 tozinameran vaccine: Report of a case and review of a World Health Organization pharmacovigilance database.

Lipschütz ulcer (LU) is a condition known for painful vulvar ulcers, typically affecting young women and often linked to infectious agents. Recent reports have indicated a potential connection between LU and COVID-19 vaccination, particularly after the second or booster doses. This study presents a case of LU following the first dose of tozinameran in a young woman who had a previous SARS-CoV-2 infection and investigates similar cases globally.

Dental Adverse Effects of Anti-CD20 Therapies.

Introduction: Over the past few years, anti-CD20 therapies like rituximab, ocrelizumab or ofatumumab have seen an increase in interest in the treatment of neurological autoimmune disorders such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), or resistant forms of generalized myasthenia gravis (MG). They are generally well-tolerated, but recent reports have highlighted severe dental disorders in patients undergoing anti-CD20 therapies. The aim was to describe a series of cases and to compare with the available scientific literature.

Integrative systems biology of wheat susceptibility to Fusarium graminearum uncovers a conserved gene regulatory network and identifies master regulators targeted by fungal core effectors.

Background: Plant diseases are driven by an intricate set of defense mechanisms counterbalanced by the expression of host susceptibility factors promoted through the action of pathogen effectors. In spite of their central role in the establishment of the pathology, the primary components of plant susceptibility are still poorly understood and challenging to trace especially in plant-fungal interactions such as in Fusarium head blight (FHB) of bread wheat. Designing a system-level transcriptomics approach, we leveraged the analysis of wheat responses from a susceptible cultivar facing Fusarium graminearum strains of different aggressiveness and examined their constancy in four other wheat cultivars also developing FHB.

An artificial intelligence algorithm for co-clustering to help in pharmacovigilance before and during the COVID-19 pandemic.

Aims: Monitoring drug safety in real-world settings is the primary aim of pharmacovigilance. Frequent adverse drug reactions (ADRs) are usually identified during drug development. Rare ones are mostly characterized through post-marketing scrutiny, increasingly with the use of data mining and disproportionality approaches, which lead to new drug safety signals.

Drug-induced cardiac toxicity and adverse drug reactions, a narrative review.

Drug-induced cardiotoxicity is a primary concern in both drug development and clinical practice. Although the heart is not a common target for adverse drug reactions, some drugs still cause various adverse cardiac events, with sometimes severe consequences. Direct cardiac toxicity encompasses functional and structural changes of the cardiovascular system due to possible exposure to medicines.

Pharmacovigilance follow-up of patients in the context of the COVID-19 pandemic.

Introduction: In the context of COVID-19 pandemic, a national pharmacovigilance survey was set up in March 2020. The purpose of this survey was to ensure continuous monitoring of adverse drug reactions (ADRs) in patients with COVID-19, not only related to the drugs used in this indication but also related to all drugs administered to these patients or suspected of having promoted the infection.

Material And Methods: This descriptive study was based on data extracted from the French Pharmacovigilance Database from 1 January 2020 to 30 September 2021.

Sphingosine-1 Phosphate Receptor Modulators Increase In Vitro Melanoma Cell Line Proliferation at Therapeutic Doses Used in Patients with Multiple Sclerosis.

Introduction: S1P receptor modulators (S1P-RM) are oral disease-modifying therapies (DMTs) for multiple sclerosis (MS). Several authorities have raised doubts that S1P-RM are responsible for an increased risk of melanoma in patients with MS. We studied the in vitro effects of S1P-RM on different melanoma cell lines to compare the effect of available S1P-RM on the proliferation of human melanoma cells.

Risk factors associated with immune checkpoint inhibitor-induced acute kidney injury compared with other immune-related adverse events: a case-control study.

Background: Immune checkpoint inhibitors (ICIs) foster anti-cancer immune responses. Their efficacy comes at the cost of immune-related adverse events (IRAEs). The latter affects various organs, including kidneys, mostly as acute tubulointerstitial nephritis, the pathophysiology of which remains unclear.

Medications as a Trigger of Sleep-Related Eating Disorder: A Disproportionality Analysis.

Sleep-related eating disorder (SRED) is a parasomnia with recurrent, involuntary, amnestic eating episodes during sleep. There is growing evidence of the association between SRED and medications. Therefore, we aimed to rank drugs showing the strongest association.

Adverse Drug Reactions of Olanzapine, Clozapine and Loxapine in Children and Youth: A Systematic Pharmacogenetic Review.

Children and youth treated with antipsychotic drugs (APs) are particularly vulnerable to adverse drug reactions (ADRs) and prone to poor treatment response. In particular, interindividual variations in drug exposure can result from differential metabolism of APs by cytochromes, subject to genetic polymorphism. is pivotal in the metabolism of the APs olanzapine, clozapine, and loxapine, whose safety profile warrants caution.

Filler-induced blindness "seen" by ophthalmologists: Case presentation and treatment algorithm.

Purpose: Filler-induced blindness (FIB) is the most threatening complication following periocular injection. To date, no standard of care has been established. The goal of this study is to report a new case of FIB with partial visual recovery and present our personalized algorithm for treatment based on fluorescein angiography findings.

COVID-19 Vaccine-Associated Transient Global Amnesia: A Disproportionality Analysis of the WHO Safety Database.

Coronavirus disease 2019 (COVID-19) spread rapidly, resulting in a global pandemic for which vaccines were quickly developed. As their safety continues to be monitored, cases of transient global amnesia (TGA) following mRNA vaccination with elasomeran have been reported. TGA is characterized by sudden onset of anterograde amnesia with preservation of other cognitive functions and resolution within 24 h.

Calcitonin gene-related peptide-targeting drugs and Raynaud's phenomenon: a real-world potential safety signal from the WHO pharmacovigilance database.

Background: Migraine is responsible for significant disability and societal burden. Recently, drugs targeting the calcitonin gene-related peptide (CGRP) pathway raised new hopes. CGRP, a potent vasodilator, plays a key role in the pathogenesis of migraine attacks.

Case Report: Severe Hypercalcemia Following Vitamin D Intoxication in an Infant, the Underestimated Danger of Dietary Supplements.

Vitamin D supplementation is routinely introduced in infants, according to medical guidelines. However, vitamin D overdose can result in life-threatening hypercalcemia. We report the case of a 3-month-old infant who suffered from severe hypercalcemia.

Infection Strategy in Wheat Involves a Highly Conserved Genetic Program That Controls the Expression of a Core Effectome.

, the main causal agent of Fusarium Head Blight (FHB), is one of the most damaging pathogens in wheat. Because of the complex organization of wheat resistance to FHB, this pathosystem represents a relevant model to elucidate the molecular mechanisms underlying plant susceptibility and to identify their main drivers, the pathogen's effectors. Although the catalog of effectors has been well characterized at the genome scale, in planta studies are needed to confirm their effective accumulation in host tissues and to identify their role during the infection process.

Spontaneous reporting of adverse drug reactions as an outlet for patient dismay? The case of Levothyrox® change of excipients.

Following minor changes of excipients of Levothyrox®, the French Pharmacovigilance Database was overwhelmed by patients' spontaneous reports of adverse drug reactions associated with the new formula. After noticing that most of these reports differed from those related to other drugs, we aimed to characterize their features and compared them with spontaneous reports associated with other chronic treatments as comparators. We randomly sampled patient reports associated with either Levothyrox® new formula (n = 200) or comparator drugs (n = 200) from March 2017 till March 2018 from the National Pharmacovigilance Database.