899 serious adverse events including 13 deaths, 7 strokes, 211 thromboembolic events, and 482 immune reactions: The untold story of cyanoacrylate adhesive closure.

Parsi, K ; Zhang, L ; et al.

In: Phlebology, Jg. 39 (2024-03-01), Heft 2, S. 80

academicJournal

Objective: The aim was to retrieve and analyse the serious adverse events of venous occlusion systems used in cyanoacrylate adhesive closure (CAC) submitted to regulatory agencies.

Methods: The Total Product Life Cycle (TPLC) database of the US Food and Drug Administration (FDA), the Database of Adverse Event Notifications (DAEN) of the Australian Therapeutic Goods Administration (TGA), and the Yellow Card database of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were reviewed. Three Freedom of Information (FOI) requests had to be submitted to the MHRA to obtain data.

Results: The TPLC contained 899 reports which included 13 cases of death, 7 strokes, 211 thromboembolic events, and 482 immune reactions. The DAEN recorded three reportable adverse events, and the MHRA recorded seven adverse incidents including one death.

Conclusion: CAC is associated with serious adverse events including death. These events are under-reported in the medical literature and only sub-optimally reported to the regulatory agencies.

Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Titel:	899 serious adverse events including 13 deaths, 7 strokes, 211 thromboembolic events, and 482 immune reactions: The untold story of cyanoacrylate adhesive closure.
Autor/in / Beteiligte Person:	Parsi, K ; Zhang, L ; Whiteley, MS ; Vuong, S ; Kang, M ; Naidu, N ; Grace, J ; Connor, DE
Zeitschrift:	Phlebology, Jg. 39 (2024-03-01), Heft 2, S. 80
Veröffentlichung:	Oct. 2012- : London : Sage ; <i>Original Publication</i>: [Houndmills, Basingstoke, Hampshire, UK] : Scientific & Medical, Macmillan Press,, 2024
Medientyp:	academicJournal
ISSN:	1758-1125 (electronic)
DOI:	10.1177/02683555231211086
Schlagwort:	Humans Adhesives Australia epidemiology Databases, Factual Cyanoacrylates adverse effects Thromboembolism
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article Language: English [Phlebology] 2024 Mar; Vol. 39 (2), pp. 80-95. <i>Date of Electronic Publication: </i>2023 Oct 30. MeSH Terms: Cyanoacrylates* / adverse effects ; Thromboembolism* ; Humans ; Adhesives ; Australia / epidemiology ; Databases, Factual Contributed Indexing: Keywords: Cyanoacrylate adhesive closure; FDA; TGA; Yellow Card System; cyanoacrylate glue; n-butyl cyanoacrylate; venous occlusion system Substance Nomenclature: 0 (Cyanoacrylates) ; 0 (Adhesives) Entry Date(s): Date Created: 20231030 Date Completed: 20240221 Latest Revision: 20240221 Update Code: 20240221

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