Nanomedicinal products: a survey on specific toxicity and side effects

Walter Brand,1,* Cornelle W Noorlander,1,* Christina Giannakou,2,3 Wim H De Jong,2 Myrna W Kooi,1 Margriet VDZ Park,2 Rob J Vandebriel,2 Irene EM Bosselaers,4 Joep HG Scholl,5 Robert E Geertsma2 1Centre for Safety of Substances and Products, 2Centre for Health Protection, National Institute for Pub...

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Autores principales:	Brand W, Noorlander CW, Giannakou C, De Jong WH, Kooi MW, Park MVDZ, Vandebriel RJ, Bosselaers IEM, Scholl JHG, Geertsma RE
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	Adverse effects Drug safety Immunotoxicity Nanomedicine Nanotoxicology Pharmacovigilance Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/574bf00bea8143c08df144926a48c06c
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spelling	oai:doaj.org-article:574bf00bea8143c08df144926a48c06c2021-12-02T01:32:49ZNanomedicinal products: a survey on specific toxicity and side effects1178-2013https://doaj.org/article/574bf00bea8143c08df144926a48c06c2017-08-01T00:00:00Zhttps://www.dovepress.com/nanomedicinal-products-a-survey-on-specific-toxicity-and-side-effects-peer-reviewed-article-IJNhttps://doaj.org/toc/1178-2013Walter Brand,1,* Cornelle W Noorlander,1,* Christina Giannakou,2,3 Wim H De Jong,2 Myrna W Kooi,1 Margriet VDZ Park,2 Rob J Vandebriel,2 Irene EM Bosselaers,4 Joep HG Scholl,5 Robert E Geertsma2 1Centre for Safety of Substances and Products, 2Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, 3Department of Toxicogenomics, Maastricht University, Maastricht, 4Section Pharmacology, Toxicology and Pharmacokinetics, Medicines Evaluation Board (CBG-MEB), Utrecht, 5Research & Analysis Department, Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, the Netherlands *These authors contributed equally to this work Abstract: Due to their specific properties and pharmacokinetics, nanomedicinal products (NMPs) may present different toxicity and side effects compared to non-nanoformulated, conventional medicines. To facilitate the safety assessment of NMPs, we aimed to gain insight into toxic effects specific for NMPs by systematically analyzing the available toxicity data on approved NMPs in the European Union. In addition, by comparing five sets of products with the same active pharmaceutical ingredient (API) in a conventional formulation versus a nanoformulation, we aimed to identify any side effects specific for the nano aspect of NMPs. The objective was to investigate whether specific toxicity could be related to certain structural types of NMPs and whether a nanoformulation of an API altered the nature of side effects of the product in humans compared to a conventional formulation. The survey of toxicity data did not reveal nanospecific toxicity that could be related to certain types of structures of NMPs, other than those reported previously in relation to accumulation of iron nanoparticles (NPs). However, given the limited data for some of the product groups or toxicological end points in the analysis, conclusions with regard to (a lack of) potential nanomedicine-specific effects need to be considered carefully. Results from the comparison of side effects of five sets of drugs (mainly liposomes and/or cytostatics) confirmed the induction of pseudo-allergic responses associated with specific NMPs in the literature, in addition to the side effects common to both nanoformulations and regular formulations, eg, with liposomal doxorubicin, and possibly liposomal daunorubicin. Based on the available data, immunotoxicological effects of certain NMPs cannot be excluded, and we conclude that this end point requires further attention. Keywords: adverse effects, drug safety, immunotoxicity, nanomedicine, nanotoxicology, pharmacovigilanceBrand WNoorlander CWGiannakou CDe Jong WHKooi MWPark MVDZVandebriel RJBosselaers IEMScholl JHGGeertsma REDove Medical PressarticleAdverse effectsDrug safetyImmunotoxicityNanomedicineNanotoxicologyPharmacovigilanceMedicine (General)R5-920ENInternational Journal of Nanomedicine, Vol Volume 12, Pp 6107-6129 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Adverse effects Drug safety Immunotoxicity Nanomedicine Nanotoxicology Pharmacovigilance Medicine (General) R5-920
spellingShingle	Adverse effects Drug safety Immunotoxicity Nanomedicine Nanotoxicology Pharmacovigilance Medicine (General) R5-920 Brand W Noorlander CW Giannakou C De Jong WH Kooi MW Park MVDZ Vandebriel RJ Bosselaers IEM Scholl JHG Geertsma RE Nanomedicinal products: a survey on specific toxicity and side effects
description	Walter Brand,1,* Cornelle W Noorlander,1,* Christina Giannakou,2,3 Wim H De Jong,2 Myrna W Kooi,1 Margriet VDZ Park,2 Rob J Vandebriel,2 Irene EM Bosselaers,4 Joep HG Scholl,5 Robert E Geertsma2 1Centre for Safety of Substances and Products, 2Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, 3Department of Toxicogenomics, Maastricht University, Maastricht, 4Section Pharmacology, Toxicology and Pharmacokinetics, Medicines Evaluation Board (CBG-MEB), Utrecht, 5Research & Analysis Department, Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, the Netherlands *These authors contributed equally to this work Abstract: Due to their specific properties and pharmacokinetics, nanomedicinal products (NMPs) may present different toxicity and side effects compared to non-nanoformulated, conventional medicines. To facilitate the safety assessment of NMPs, we aimed to gain insight into toxic effects specific for NMPs by systematically analyzing the available toxicity data on approved NMPs in the European Union. In addition, by comparing five sets of products with the same active pharmaceutical ingredient (API) in a conventional formulation versus a nanoformulation, we aimed to identify any side effects specific for the nano aspect of NMPs. The objective was to investigate whether specific toxicity could be related to certain structural types of NMPs and whether a nanoformulation of an API altered the nature of side effects of the product in humans compared to a conventional formulation. The survey of toxicity data did not reveal nanospecific toxicity that could be related to certain types of structures of NMPs, other than those reported previously in relation to accumulation of iron nanoparticles (NPs). However, given the limited data for some of the product groups or toxicological end points in the analysis, conclusions with regard to (a lack of) potential nanomedicine-specific effects need to be considered carefully. Results from the comparison of side effects of five sets of drugs (mainly liposomes and/or cytostatics) confirmed the induction of pseudo-allergic responses associated with specific NMPs in the literature, in addition to the side effects common to both nanoformulations and regular formulations, eg, with liposomal doxorubicin, and possibly liposomal daunorubicin. Based on the available data, immunotoxicological effects of certain NMPs cannot be excluded, and we conclude that this end point requires further attention. Keywords: adverse effects, drug safety, immunotoxicity, nanomedicine, nanotoxicology, pharmacovigilance
format	article
author	Brand W Noorlander CW Giannakou C De Jong WH Kooi MW Park MVDZ Vandebriel RJ Bosselaers IEM Scholl JHG Geertsma RE
author_facet	Brand W Noorlander CW Giannakou C De Jong WH Kooi MW Park MVDZ Vandebriel RJ Bosselaers IEM Scholl JHG Geertsma RE
author_sort	Brand W
title	Nanomedicinal products: a survey on specific toxicity and side effects
title_short	Nanomedicinal products: a survey on specific toxicity and side effects
title_full	Nanomedicinal products: a survey on specific toxicity and side effects
title_fullStr	Nanomedicinal products: a survey on specific toxicity and side effects
title_full_unstemmed	Nanomedicinal products: a survey on specific toxicity and side effects
title_sort	nanomedicinal products: a survey on specific toxicity and side effects
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/574bf00bea8143c08df144926a48c06c
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Nanomedicinal products: a survey on specific toxicity and side effects

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