Data and materials for "Adverse drug withdrawal event signals in FAERS and Eudravigilance databases: a stratified disproportionality analysis study"

This comprises the data and materials used for the study by Khan et al. 2026 (ongoing) entitled "Adverse drug withdrawal event signals in FAERS and Eudravigilance databases: a stratified disproportionality analysis study".

# Explanation

This repository contains the Stata and R scripts used for the disproportionality analysis of adverse drug withdrawal events (ADWEs) reported in the US Food and Drug Administration Adverse Event Reporting System (FDA-FAERS) and European Medicines Agency Eudravigilance (EMA-EV) databases.

The scripts include:

# FDA-FAERS_Disprop_DataPrep (.do and .txt)

"Scripts for merging datasets, deduplication, drug variable cleaning, and preparation of analysis datasets for disproportionality analysis."

# FDA-FAERS_Stratified_Disproportionality (.R and .txt)

"Scripts for drug-level, sex-stratified, age-stratified, time-period, intra-class (between drug classes), and inter-class (between drugs within drug classes) disproportionality analyses using FDA-FAERS data."

# EMA-EV_Stratified_Disproportionality (.R and .txt)

"Scripts for drug-level, sex-stratified, age-stratified, time-period, intra-class (between drug classes), and inter-class (between drugs within drug classes) disproportionality analyses using EMA-EV data."

# Related work

The data preparation workflow and descriptive analyses supporting this work are available in the related Zenodo repository: https://doi.org/10.5281/zenodo.18155023

*Note:  These analysis scripts are part of Work Package 2 (Part 2) of the HORIZON EUROPE Marie Skłodowska-Curie Actions project "Harnessing Evidence on Adverse Drug Withdrawal Events following Deprescribing through the Pharmacovigilance System (HEAD-P)".

# Project description

The project description can be found here: https://cordis.europa.eu/project/id/101149577

# Project Aim

The aim of HEAD-P is to establish the current evidence base on adverse drug withdrawal events (ADWEs) and explore how this can be enhanced via the pharmacovigilance system. This research project focus on the establishing the current extent of evidence for ADWEs following deprescribing from various sources, including published literature and pharmacovigilance spontaneous reporting systems, and evaluating how the generation of evidence on ADWEs can be fostered, to ultimately inform deprescribing decisions in practice. This research project involves innovative approaches, applying and combining existing and recent methods in new ways (evidence synthesis, data analysis and data mining, and qualitative approaches), comprehensively assessing pharmacovigilance reporting data across all drug classes and taking a multi-stakeholder and multi-faceted perspective to stimulate the generation of ADWE evidence.

# Research Objectives and Work Packages

*WP1/RO1* 

To assess evidence on the rate of occurrence and characteristics of ADWEs.

Registered Protocol: https://osf.io/fmy5t/overview

*WP2/RO2*

To analyse pharmacovigilance data in Europe and the United States of America to examine the reporting of adverse events relating to ADWEs of all drugs.

Registered Protocol: https://osf.io/utcwb/overview

*WP3/RO3*

To identify all recommendations relating to monitoring, detection, and reporting of ADWEs included in guidance and review the content of these recommendations.

Registered Protocol: https://osf.io/pbm83/overview

*WP4/RO4*

To investigate policymaker perspectives on the integration of ADWE reporting in the pharmacovigilance system.

Registered Protocol: https://osf.io/r6jnv/overview

Funding and disclaimer

This research is funded by the European Union through the Marie Skłodowska-Curie Actions (MSCA) programme (Project acronym: HEAD-P; Project number: 101149577) https://cordis.europa.eu/project/id/101149577.  Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Research Executive Agency (REA). Neither the European Union nor the granting authority can be held responsible for them.