Literature DB >> 32880367

How FDA Failures Contributed to the Opioid Crisis.

Andrew Kolodny1.   

Abstract

Over the past 25 years, pharmaceutical companies deceptively promoted opioid use in ways that were often neither safe nor effective, contributing to unprecedented increases in prescribing, opioid use disorder, and deaths by overdose. This article explores regulatory mistakes made by the US Food and Drug Administration (FDA) in approving and labeling new analgesics. By understanding and correcting these mistakes, future public health crises caused by improper pharmaceutical marketing might be prevented.
© 2020 American Medical Association. All Rights Reserved.

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Year:  2020        PMID: 32880367     DOI: 10.1001/amajethics.2020.743

Source DB:  PubMed          Journal:  AMA J Ethics


  3 in total

1.  Associations Between Aggregate NLP-Extracted Conflicts of Interest and Adverse Events by Drug Product.

Authors:  S Scott Graham; Zoltan P Majdik; Johua B Barbour; Justin F Rousseau
Journal:  Stud Health Technol Inform       Date:  2022-06-06

2.  Pharmacovigilance Signals of the Opioid Epidemic over 10 Years: Data Mining Methods in the Analysis of Pharmacovigilance Datasets Collecting Adverse Drug Reactions (ADRs) Reported to EudraVigilance (EV) and the FDA Adverse Event Reporting System (FAERS).

Authors:  Stefania Chiappini; Rachel Vickers-Smith; Amira Guirguis; John M Corkery; Giovanni Martinotti; Daniel R Harris; Fabrizio Schifano
Journal:  Pharmaceuticals (Basel)       Date:  2022-05-27

3.  On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data.

Authors:  Jessie Pappin; Itai Bavli; Matthew Herder
Journal:  Clin Trials       Date:  2022-08-04       Impact factor: 2.599

  3 in total

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