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Consequences to Patients, Clinicians, and Manufacturers When Titanic Adverse Drug Reactions are Identified (1997- 2019): A Report from the Southern Network on Adverse Reactions (SONAR)

Charles L. Bennett, Shamia Hoque, David Aboulafia, Courtney Lubaczewski, Andrew C. Bennett, Jay Vemula, Benjamin Schooley, Matthew A. Taylor, Bartlett J. Witherspoon, Ashley Godwin,
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Published: 1 January 2020

Abstract: Introduction: Adverse drug/device reactions (ADRs) can result in severe patient harm. We operationally define titanic ADRs as Common Toxicity Criteria Adverse Events grade 4 or 5 that follow use of drugs or devices that have large sales, large safety financial settlements, and affect large numbers of persons. We report on the impact of titanic ADRs identified between 1997 and 2019. Methods: We reviewed clinician reported titanic ADRs. Data sources included Food and Drug Advisory (FDA) Advisory Committee transcripts, news reports, and medical journals. We reviewed data on timing of titanic ADR reports, Boxed warnings, product withdrawals, and impacts on patients, clinicians, and manufacturers. Results: Overall, twenty titanic ADRs involved 15 drugs and 1 device. Legal settlements totaled $38.4 billion for 874,000 persons reportedly developing titanic ADRs. Five clinicians reported receiving threats from manufacturers’ employees, one clinician lost a university faculty position, and five clinicians were not invited to FDA meetings where their safety findings were discussed. Annual sales for 9 still patented drugs and 1 device decreased 78% from $21.3 billion pre-ADR report to $3.9 billion afterwards. Following FDA approval, the median time to titanic ADRs reporting was 7.5 years. Fourteen drugs received Box warnings a median of 7.5 years following titanic ADR reporting. Six drugs and 1 device were withdrawn from marketing (median of 5 years after titanic ADR reporting). Conclusion: Overall, 874,000 persons were purportedly injured by fifteen drugs and one device that caused titanic ADRs, reputational harms were reported by eleven clinicians , and $38.4 billion in legal settlements were paid . Because titanic ADRs impacts are so large, and investigative processes not always transparent, policy makers should develop an independently funded drug safety board.Funding Statement: This work received support from the National Cancer Institute (1R01 A102713 (CLB), https://www.nih.gov/about-nih/what-we-do/nih-almanac/national-cancer-institute-nci; the American Cancer Society (IRG-13-043-01), https://www.cancer.org/; and an unrestricted grant from Doris Levkoff Meddin. Declaration of Interests: The authors have declared that no competing interests exist.
Keywords: adverse drug reaction / liability / patient harm / toxicity

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