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Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors

The summary of product characteristics (SmPCs) is an important information source that includes the adverse drug reactions (ADRs) associated with the drug. Drugs with the same mechanism of action are expected to have a similar ADR profile and thus a substantial overlap of the described ADRs in the S...

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Autores principales: Minnema, Lotte A., Giezen, Thijs J., Hoekman, Jarno, Egberts, Toine C.G., Leufkens, Hubert G.M., Gardarsdottir, Helga
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8359229/
https://www.ncbi.nlm.nih.gov/pubmed/33278830
http://dx.doi.org/10.1002/cpt.2127
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author Minnema, Lotte A.
Giezen, Thijs J.
Hoekman, Jarno
Egberts, Toine C.G.
Leufkens, Hubert G.M.
Gardarsdottir, Helga
author_facet Minnema, Lotte A.
Giezen, Thijs J.
Hoekman, Jarno
Egberts, Toine C.G.
Leufkens, Hubert G.M.
Gardarsdottir, Helga
author_sort Minnema, Lotte A.
collection PubMed
description The summary of product characteristics (SmPCs) is an important information source that includes the adverse drug reactions (ADRs) associated with the drug. Drugs with the same mechanism of action are expected to have a similar ADR profile and thus a substantial overlap of the described ADRs in the SmPC. The objective of this study is to assess this overlap. We extracted all ADRs (excluding hypersensitivity and administration site reactions) that were described in the first and all subsequent versions of the SmPCs of all approved TNF‐α inhibitors in the European Union. The Medical Dictionary for Regulatory Activities was used to characterize the ADRs. At the end of follow‐up, 293 unique ADRs (at high level term level) were described in the SmPCs of the 5 TNF‐α inhibitors. There was substantial variation in the number of ADRs described in the SmPC among the TNF‐α inhibitors. Of the 293 ADRs, 133 (45%) were described in the SmPC of one TNF‐α inhibitor and 39 (13%) in the SmPCs of all 5 TNF‐α inhibitors. Serious ADRs and ADRs classified as important risks were described approximately four times more often in a second SmPC than ADRs not classified as such. In conclusion, the ADRs described in the SmPCs of the TNF‐α inhibitors differ considerably in number and type. In order to adequately inform prescribers and patients, acquired knowledge of the safety profile of drugs with the same mechanism of action should increasingly be taken into account in the assessment of all drugs within the class.
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spelling pubmed-83592292021-08-17 Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors Minnema, Lotte A. Giezen, Thijs J. Hoekman, Jarno Egberts, Toine C.G. Leufkens, Hubert G.M. Gardarsdottir, Helga Clin Pharmacol Ther Research The summary of product characteristics (SmPCs) is an important information source that includes the adverse drug reactions (ADRs) associated with the drug. Drugs with the same mechanism of action are expected to have a similar ADR profile and thus a substantial overlap of the described ADRs in the SmPC. The objective of this study is to assess this overlap. We extracted all ADRs (excluding hypersensitivity and administration site reactions) that were described in the first and all subsequent versions of the SmPCs of all approved TNF‐α inhibitors in the European Union. The Medical Dictionary for Regulatory Activities was used to characterize the ADRs. At the end of follow‐up, 293 unique ADRs (at high level term level) were described in the SmPCs of the 5 TNF‐α inhibitors. There was substantial variation in the number of ADRs described in the SmPC among the TNF‐α inhibitors. Of the 293 ADRs, 133 (45%) were described in the SmPC of one TNF‐α inhibitor and 39 (13%) in the SmPCs of all 5 TNF‐α inhibitors. Serious ADRs and ADRs classified as important risks were described approximately four times more often in a second SmPC than ADRs not classified as such. In conclusion, the ADRs described in the SmPCs of the TNF‐α inhibitors differ considerably in number and type. In order to adequately inform prescribers and patients, acquired knowledge of the safety profile of drugs with the same mechanism of action should increasingly be taken into account in the assessment of all drugs within the class. John Wiley and Sons Inc. 2020-12-28 2021-07 /pmc/articles/PMC8359229/ /pubmed/33278830 http://dx.doi.org/10.1002/cpt.2127 Text en © 2020 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research
Minnema, Lotte A.
Giezen, Thijs J.
Hoekman, Jarno
Egberts, Toine C.G.
Leufkens, Hubert G.M.
Gardarsdottir, Helga
Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors
title Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors
title_full Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors
title_fullStr Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors
title_full_unstemmed Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors
title_short Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors
title_sort regulatory safety learning driven by the mechanism of action: the case of tnf‐α inhibitors
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8359229/
https://www.ncbi.nlm.nih.gov/pubmed/33278830
http://dx.doi.org/10.1002/cpt.2127
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