Evaluating the Impact of Black Box Warning Updates on the Reporting of Drug-Related Adverse Events: a Cross Sectional Study of the FAERS Database-Reference-Cited by-同舟云学术

Evaluating the Impact of Black Box Warning Updates on the Reporting of Drug-Related Adverse Events: a Cross Sectional Study of the FAERS Database

Published:2023-01-27 Issue:6 Volume:22 Page:463-468
ISSN:1474-0338
Container-title:Expert Opinion on Drug Safety
language:en
Short-container-title:Expert Opinion on Drug Safety

Author:

Yavne Yarden¹²^ORCID,Amar Shamir Reut²,Shapiro Michael¹²,Shepshelovich Daniel²³

Affiliation:

1. Department of Medicine ‘T,’ Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

2. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

3. Department of Medicine ‘D,’ Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/14740338.2023.2172160

Reference29 articles.

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2. Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) [Internet]. Available from: https://www.govinfo.gov/content/pkg/PLAW-110publ85/html/PLAW-110publ85.htm

3. FDA’s Adverse Event Reporting System (FAERS) [Internet]. Available from: https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers

4. Research C for DE and. FDA Adverse Event Reporting System (FAERS) Public Dashboard. FDA [Internet]. 2021 [cited 2022 Feb 1]; Available from: https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard.

5. Adverse Drug Event Surveillance and Drug Withdrawals in the United States, 1969-2002

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