58 Result(s)

Article

Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis

Emanuel Raschi, Francesco Salvo, Andrew Bate, Fabrizio De Ponti… in Drug Safety (2024)

Article

The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement

Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their methods and resul...

Michele Fusaroli, Francesco Salvo, Bernard Begaud, Thamir M. AlShammari… in Drug Safety (2024)

Article

The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelin...

Michele Fusaroli, Francesco Salvo, Bernard Begaud, Thamir M. AlShammari… in Drug Safety (2024)

Article

Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS

In refining drug safety signals, defining the object of study is crucial. While research has explored the effect of different event definitions, drug definition is often overlooked. The US FDA Adverse Event Re...

Michele Fusaroli, Valentina Giunchi, Vera Battini, Stefano Puligheddu… in Drug Safety (2024)

Chapter

Ethical Review of In Silico Methodologies

Cécile F. Rousseau, Emmanuelle M. Voisin… in Toward Good Simulation Practice (2024)

Article

Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach

Valentina Giunchi, Michele Fusaroli, Manfred Hauben, Emanuel Raschi… in Drug Safety (2023)

Article

Map** Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study

Disproportionality analysis is traditionally used in spontaneous reporting systems to generate working hypotheses about potential adverse drug reactions: the so-called disproportionality signals. We aim to map...

Michele Fusaroli, Francesco Salvo, Claire Bernardeau, Maryam Idris… in Drug Safety (2023)

Article

Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System

Deliberate self-poisoning (DSP) using drugs is the preferred method of suicide at a global level. Its investigation is hampered by limited sample sizes and data reliability. We investigate the role of the US F...

Michele Fusaroli, Guido Pelletti, Valentina Giunchi, Chiara Pugliese… in Drug Safety (2023)

Article

Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database

As chimeric antigen receptor T-cell therapies are becoming increasingly available in the armamentarium of the hematologist, there is an emerging need to monitor post-marketing safety.

Michele Fusaroli, Valentina Isgrò, Paola Maria Cutroneo, Carmen Ferrajolo… in Drug Safety (2022)

Article

COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety

To date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVI...

Nicoletta Luxi, Alexia Giovanazzi, Annalisa Capuano, Salvatore Crisafulli… in Drug Safety (2021)

Article

Cyclin-dependent kinase 4/6 inhibitors and interstitial lung disease in the FDA adverse event reporting system: a pharmacovigilance assessment

We assessed pulmonary toxicity of cyclin-dependent kinase (CDK)4/6 inhibitors by analyzing the publicly available FDA Adverse Event Reporting System (FAERS).

Emanuel Raschi, Michele Fusaroli, Andrea Ardizzoni… in Breast Cancer Research and Treatment (2021)

Article

The Complex Management of Atrial Fibrillation and Cancer in the COVID-19 Era: Drug Interactions, Thromboembolic Risk, and Proarrhythmia

Cardiotoxicity by anticancer agents has emerged as a multifaceted issue and is expected to affect both mortality and morbidity. This review summarizes clinical challenges in the management of oncological patie...

Milo Gatti, Emanuel Raschi, Elisabetta Poluzzi… in Current Heart Failure Reports (2020)

Article

Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis

The European Medicines Agency has suspended the use of ulipristal acetate (UPA) in the treatment of uterine fibroids and is reassessing its association with a risk of liver injury.

Milo Gatti, Elisabetta Poluzzi, Fabrizio De Ponti, Emanuel Raschi in Drug Safety (2020)

Article

Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance

Emanuel Raschi, Michele Fusaroli, Igor Diemberger, Elisabetta Poluzzi in Drug Safety (2020)