A scoping systematic assessment for post-marketing abuse drug withdrawal

Abstract

Objectives The aim of this study was to identify the post-marketing withdrawal of medicines due to their adverse drug reactions (ADRs)-related abuse effects and to examine the types of evidence, mechanisms and patterns for the withdrawal decisions after their approval across different geographical regions. Methods By searching through different databases that focused on withdrawn drugs due to their ADRs-related abuse effects between 1930 and 2021 that could provide findings of evidence used in making withdrawal decisions based on the tools of the Oxford Centre for Evidence-Based Medicine (OCEBM) criteria alongside sources derived from authorities based on their withdrawal. The outcomes were categorized, and the average time between the launch date of exposure and withdrawal was calculated and stratified. Key findings A total of 33 abused withdrawn drugs. The withdrawals occurred between 1961 and 2007. Psychostimulant drugs accounted for most of the abuse withdrawals (42.4%). Most of the withdrawals occurred between 1981 and 1990 (n = 18, 54.5%). Most withdrawn drugs were in Europe (41, 46.6%) with a minimum withdrawal period of 5 years and an average time of withdrawal of 28.8 years. Conclusions Psychostimulant drugs presented the most abuse withdrawals based on the evidence of case-control studies, and the most withdrawals were in Europe. The duration of withdrawn drugs was different from region to region in different continents. More intensive research is required to further reduce the time duration between drug marketing and withdrawal, which will help improve decision-making processes with favourable benefit-risk ratio outcomes.