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Current Drug Safety

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ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

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Research Article

An Audit of Black Box Warnings (BBWs) in the United States Food and Drug Administration (US-FDA) Database - A Five-Year Analysis

Author(s): Debdipta Bose, Nithya Gogtay, Tejusv Goel and Mahanjit Konwar*

Volume 17, Issue 1, 2022

Published on: 11 August, 2021

Page: [54 - 58] Pages: 5

DOI: 10.2174/1574886316666210811161939

Price: $65

Abstract

Background: The Black-Box Warning (BBW) is the most serious warning that US-FDA can ask for on a drug’s labelling. BBWs represent key safety concerns uncovered either during dossier review or post-approval. We have conducted the present study with the primary objective of assessing BBWs issued by the US-FDA.

Methods: BBWs were identified on US-FDA’s website from 1st January 2015 to 31st December, 2019. Prescribing information was used to identify and characterize BBWs into new and minor/major updates on a previous BBW. The therapeutic class of the drug, nature [Biological/New Molecular entity (NME)], formulation type, expected duration of use, along with the year of first approval of the molecule with BBWs were evaluated.

Results: A total of n = 167 BBWs were issued by the FDA of which 53 (31.7%) had major updates, 57(34.1%) had minor updates and 57(34.1%) were new BBWs. A total of 137(82%) of BBWs were with NME’s whereas 30(18%) were with biologics. Drugs for neurology 40(25.5%)had the highest number of BBWs, followed by oncology 38(24.2%). Among the type of BBWs, cardiovascular risk 31 (15%) were the highest.

Conclusion: Practicing physicians need to understand that benefit-risk of a drug is dynamic and keep abreast of new data related to it.

Keywords: Black box warning, pharmacovigilance, US-FDA, biologics, new molecular entity, prescribing information (PI).

« Previous Next »
[1]
Warnings and precaution, contraindications and boxed warning sections of labeling biological products. 2019. Fda.gov. Available from: https://www.fda.gov/media/71866/download [Cited: 23 July 2019]
[2]
The role of black box warnings in safe prescribing practices | Health affairs. 2019. Available from: https://www.healthaffairs.org/do/10.1377/hblog20140820.040875/full [Cited: 23 July 2019]
[3]
Solotke MT, Dhruva SS, Downing NS, Shah ND, Ross JS. New and incremental FDA black box warnings from 2008 to 2015. Expert Opin Drug Saf 2018; 17(2): 117-23.
[http://dx.doi.org/10.1080/14740338.2018.1415323] [PMID: 29215916]
[4]
Accessdata.fda.gov. 2020. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201023s021lbl.pdf [Cited: 4 February 2020]
[5]
U.S. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf
[6]
CDER’s new molecular entities and new therapeutic biological products. U.S. Food and drug administration. 2020. Available from: https://www.fda.gov/drugs/development-approval-process- drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products [Cited: 1 March 2020]
[7]
U.S. Food and Drug Administration. 2020. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022345s011lbl.pdf [Cited: 16 March 2020]
[8]
U.S. Food and Drug Administration. 2020. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125516s011lbl.pdfhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125516s011lbl.pdf [Cited: 16 March 2020]
[9]
Krumholz HM, Ross JS, Presler AH, Egilman DS. What have we learnt from Vioxx? BMJ 2007; 334(7585): 120-3.
[http://dx.doi.org/10.1136/bmj.39024.487720.68] [PMID: 17235089]
[10]
Heyward J, Olson L, Sharfstein JM, Stuart EA, Lurie P, Alexander GC. Evaluation of the extended-release/long-acting opioid prescribing risk evaluation and mitigation strategy program by the us food and drug administration: A review. JAMA Intern Med 2020; 180(2): 301-9.
[http://dx.doi.org/10.1001/jamainternmed.2019.5459] [PMID: 31886822]
[11]
Seminara NM, Gelfand JM. Assessing long-term drug safety: Lessons (re) learned from raptiva. Semin Cutan Med Surg 2010; 29(1): 16-9.
[http://dx.doi.org/10.1016/j.sder.2010.01.001] [PMID: 20430303]
[12]
Cheng CM, Shin J, Guglielmo BJ. Trends in boxed warnings and withdrawals for novel therapeutic drugs, 1996 through 2012. JAMA Intern Med 2014; 174(10): 1704-5.
[http://dx.doi.org/10.1001/jamainternmed.2014.4854] [PMID: 25127107]

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