Fatal adverse drug reactions: A worldwide perspective in the World Health Organization pharmacovigilance database.

Aims: Adverse drug reactions (ADRs) are important causes of death. However, the main involved drugs are relatively unknown. The present study was performed to characterise death-related drugs recorded in a large pharmacovigilance database during the last 10 years.

Mapping of drug-related problems among older adults conciliating medical and pharmaceutical approaches.

Purpose: To lay the fundamentals of drug-related problems (DRPs) in older adults, and to organize them according to a logical process conciliating medical and pharmaceutical approaches, to better identify the causes and consequences of DRPs.

Materials And Methods: A narrative overview.

Results: The causes of DRPs may be intentional or unintentional.

Risk comparison of beta-lactam-induced anaphylaxis: Therapeutic stratification analysis in a Vietnamese pharmacovigilance database.

What Is Known And Objective: There is limited data on the specific risks of anaphylaxis induced by beta-lactam drugs. The aim of this study was to compare the risks of reporting beta-lactam-induced anaphylaxis using the national pharmacovigilance database of Vietnam (NPDV).

Methods: The multivariate generalised linear regression model was applied for signal generation and comparison of beta-lactams.

Tramadol-induced hypoglycemia: A pharmacovigilance study.

Several papers have reported that tramadol can induce hypoglycemia. However, in some reports, confounding factors can be found, like coadministration of hypoglycemic drugs. We used the WHO pharmacovigilance database (VigiBase®) to investigate whether tramadol alone could be associated with hypoglycemia.

Safety of immune checkpoint inhibitor rechallenge after discontinuation for grade ≥2 immune-related adverse events in patients with cancer.

Background: Safety of rechallenge of immune checkpoint inhibitor (ICI) after grade ≥2 immune-related adverse events (irAEs) leading to ICI discontinuation remains unclear.

Methods: All adverse drug reactions involving at least one ICI reported up to December 31, 2019 were extracted from the French pharmacovigilance database. Patients were included if they experienced at least one grade ≥2 irAE resulting in ICI discontinuation, with subsequent ICI rechallenge.

Severe hypertensive flare-up after intravitreal injection of ranibizumab for retinal venous branch occlusion.

Vascular endothelial growth factor (VEGF) proteins are involved in the regulation of angiogenesis. Systemic adverse effects of some anti-VEGF include hypertension, proteinuria and cardiovascular complications which could involve lower systemic VEGF levels. However, the question regarding intravitreal administration of anti-VEGF remains controversial given that the patients receiving these drugs are often elderly and present cardiac risk factors such as arterial hypertension or atrial fibrillation.

Drug-Induced Hearing Loss in Children: An Analysis of Spontaneous Reports in the French PharmacoVigilance Database.

Introduction: Hearing loss can have a negative impact on communication, with significant vocational, educational, and social consequences. Drugs are one of the causes of hearing loss in children.

Objectives: The objective of our study was to describe drug-induced hearing loss in the pediatric population.

Patterns of Benzodiazepine Use and Excess Risk of All-Cause Mortality in the Elderly: A Nationwide Cohort Study.

Introduction: Despite the risks associated with their use, benzodiazepines remain used more widely than wisely. In this context, a better understanding of how their patterns of use can be associated with an increased risk of death appears essential. Indeed, the studies that investigated this association so far are inconsistent and question the influence of potential biases.

Amiodarone and Parkinsonism: a pharmacovigilance study.

Background: Some case reports have described parkinsonism with amiodarone. We investigated a putative association between parkinsonism and exposure to amiodarone.

Methods: We used the WHO pharmacovigilance database (VigiBase ).

[Analysis of regulatory status changes of drugs in France: 2010-2019].

Objectives: The existence of borderline products between the status of a medicinal product and other less regulated products allows some products to have different statuses or even to change from one status to another. In order to quantify these changes, a review of medicines that have changed from drug status to other statuses (medical device, cosmetic product or food supplement) in France between 2010 and 2019 was performed.

Method: The lists of medicinal products with archived or revoked marketing authorization (MA) from the French National Authority's Register of Medicinal Products were analyzed in order to identify the medicinal products withdrawn from the market between January 1, 2010 and September 30, 2019 that could be considered as products with a "potential for status change".

Delivering HDAC over 3 or 5 days as consolidation in AML impacts health care resource consumption but not outcome.

Postremission treatment is crucial to prevent relapse in acute myeloid leukemia (AML). High-dose cytarabine delivered every 12 hours on days 1, 3, and 5 (HDAC-135) is the standard of care for younger adult patients with AML. Although this standard has been unsuccessfully challenged by other treatment regimens, including multiagent chemotherapy, the timing of HDAC administration has attracted little attention.

Mycobacterium bovis infection of an aortobifemoral bypass graft with Streptococcus intermedius superinfection after intravesical bacillus Calmette-Guérin immunotherapy for bladder cancer.

Background: The Bacillus Calmette-Guerin (BCG) is a life-attenuated form of Mycobacterium bovis widely used as immunotherapy for localized bladder cancer. Adverse reactions to intravesical BCG instillations are rare.

Case: We describe a 70-year-old man with a history of an aortobifemoral bypass graft, placement of a synthetic mesh for treatment of a ventral hernia and, most recently, superficial bladder cancer treated with BCG therapy.

Impact of Secured Prescription Implementation for Zolpidem on Hypnotics Use in France: A Time-Series Analysis on National Data.

We evaluated the impact of the implementation of a requirement that zolpidem prescriptions be obtained via secured forms (April 2017) on zolpidem and other hypnotics use in France. We conducted a time-series analysis on data from the French national health care system, from January 1, 2015 to January 3, 2018, for all reimbursed hypnotics. An important and immediate decrease in zolpidem use (-161,873 defined daily doses [DDD]/month; -215,425 to -108,323) was evidenced, with a concomitant raise in zopiclone use (+64,871; +26,925 to +102,817).

[Potentially inappropriate medication: Adaptation of EU(7)PIM criteria to the French medical practice].

Objective: Improving the quality of prescribing in the elderly remains a permanent concern and a major opportunity to improve patient care. The objective of this article is to propose, from updated existing lists of potentially inappropriate medication (PIM), a list of PIM adapted to the French medical practice.

Method: Combination of an explicit tool: the updated EU (7) PIM list published in 2015, adapted to the French medical practice (availability of drugs and validated indications), and an implicit tool: the recommendations of French National Health Authority (HAS) and more specifically the "alerte et maîtrise de la iatrogénie" (AMI) tools.

Adverse drug reactions in infants, children and adolescents exposed to antidepressants: a French pharmacovigilance study.

Purpose: Despite their frequent use in children and adolescents, the evidence for efficacy and safety of antidepressants (ATDs) in this population is scarce and off-label prescribing common. The aim of this study was to describe reported adverse drug reactions (ADRs) associated to ATDs over a 30-year period using the French Pharmacovigilance Database (FPVD).

Methods: We performed an analysis of ADRs registered in the FPVD from 1985 to 2016, occurred in children and adolescents receiving an ATD.

Antidepressants and movement disorders: a postmarketing study in the world pharmacovigilance database.

Background: Antidepressants-induced movement disorders are rare and imperfectly known adverse drug reactions. The risk may differ between different antidepressants and antidepressants' classes. The objective of this study was to assess the putative association of each antidepressant and antidepressants' classes with movement disorders.

β-Adrenoceptor Drugs and Parkinson's Disease: A Nationwide Nested Case-Control Study.

Background: Potential relationships between β-adrenergic drugs and α-synuclein synthesis in Parkinson's disease (PD) have been recently suggested.

Objective: This study investigated the putative association between β-adrenoceptor drug exposure and PD occurrence.

Methods: A nested case-control study was performed in the Echantillon Généraliste des Bénéficiaires (EGB) (a 1/97th random sample of affiliates to the French Insurance System).

A New Drug-Drug Interaction Between Hydroxychloroquine and Metformin? A Signal Detection Study.

Introduction: Hydroxychloroquine was recently promoted in patients infected with COVID-19 infection. A recent experimental study has suggested an increased toxicity of hydroxychloroquine in association with metformin in mice.

Objective: The present study was undertaken to investigate the reality of this putative drug-drug interaction between hydroxychloroquine and metformin using pharmacovigilance data.

Role of serotonin and norepinephrine transporters in antidepressant-induced arterial hypertension: a pharmacoepidemiological-pharmacodynamic study.

Purpose: Some reports have described arterial hypertension (AH) in patients treated by serotonin reuptake inhibitor (SRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressants. The mechanism remains discussed, some authors suggesting a role of SERT (SERotonin Transporter) inhibition whereas others discussing NET (NorEpinephrine Transporter) involvement. The present study used the pharmacoepidemiological-pharmacodynamic (PE-PD) method to investigate the role of these transporters in SRI- and SNRI-induced AH.

Chloroquine and hydroxychloroquine in the management of COVID-19: Much kerfuffle but little evidence.

Chloroquine and hydroxychloroquine are drugs that have shown in vitro activity on the replication of certain coronaviruses. In the context of the SARS-Cov-2 epidemic, the virus responsible for the novel coronavirus disease (COVID-19), these two drugs have been proposed as possible treatments. The results of the first clinical studies evaluating the effect of hydroxychloroquine do not support any efficacy of this drug in patients with COVID-19, due to major methodological weaknesses.

Can tramadol really induce hyponatraemia? A pharmacovigilance study.

Several papers have described hyponatraemia with tramadol. However, in most reports, several confounding factors can be found. We used the WHO pharmacovigilance database (VigiBase®) to investigate if tramadol alone could be associated with hyponatraemia.