Safety of Inulin and Sinistrin: Combining Several Sources for Pharmacovigilance Purposes

Introduction: Inulin and its analog sinistrin are fructose polymers used in the food and pharmaceutical industries. In 2018, The French National Agency for the Safety of Medicines and Health Products (ANSM) decided to withdraw products containing sinistrin and inulin due to several reports of seriou...

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Autores principales:	T-V. Bui, C. Prot-Bertoye, H. Ayari, S. Baron, J-P. Bertocchio, C. Bureau, P. Davis, A. Blanchard, P. Houillier, D. Prie, A. Lillo-Le Louet, M. Courbebaisse
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	inulin (PubChem CID: 16219508) safety hypersensitivity pharmacovigilance sinistrin Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/2a8e96dc6a91498e844eb4527d134946
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spelling	oai:doaj.org-article:2a8e96dc6a91498e844eb4527d1349462021-11-18T09:45:59ZSafety of Inulin and Sinistrin: Combining Several Sources for Pharmacovigilance Purposes1663-981210.3389/fphar.2021.725417https://doaj.org/article/2a8e96dc6a91498e844eb4527d1349462021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fphar.2021.725417/fullhttps://doaj.org/toc/1663-9812Introduction: Inulin and its analog sinistrin are fructose polymers used in the food and pharmaceutical industries. In 2018, The French National Agency for the Safety of Medicines and Health Products (ANSM) decided to withdraw products containing sinistrin and inulin due to several reports of serious hypersensitivity reactions, including a fatal outcome.Objective: To assess the safety of inulin and sinistrin use in France.Methods: We searched multiple sources to identify adverse reactions (ARs) to inulin or sinistrin: first, classical pharmacovigilance databases including the French Pharmacovigilance (FPVD) and the WHO Database (VigiBase); second, data from a clinical trial, MultiGFR; third, data regarding current use in an hospital. All potential ARs to inulin or sinistrin were analyzed with a focus on hypersensitivity reactions and relationships to batches of sinistrin.Results: From 1991 to 2018, 134 ARs to inulin or sinistrin were registered in the FPVD or VigiBase. Sixty-three cases (47%) were classified as serious, and 129 cases (96%) were hypersensitivity reactions. We found an association between a batch of sinistrin and the occurrence of hypersensitivity reactions. During the MultiGFR clinical trial, 7 patients (7/163 participants) had an Adverse reaction; of these, 4 were hypersensitivity reactions including one case of grade 4 anaphylactic shock. In the hospital, no ARs were observed. In the literature, ARs to inulin and sinistrin are very rarely reported and mostly benign.Conclusion: Most ARs to inulin and sinistrin are hypersensitivity reactions that appear to be associated with sinistrin batches.T-V. BuiC. Prot-BertoyeC. Prot-BertoyeC. Prot-BertoyeC. Prot-BertoyeC. Prot-BertoyeC. Prot-BertoyeH. AyariH. AyariH. AyariH. AyariS. BaronS. BaronS. BaronS. BaronS. BaronS. BaronJ-P. BertocchioJ-P. BertocchioJ-P. BertocchioJ-P. BertocchioC. BureauP. DavisA. BlanchardA. BlanchardA. BlanchardA. BlanchardA. BlanchardA. BlanchardP. HouillierP. HouillierP. HouillierP. HouillierP. HouillierP. HouillierD. PrieD. PrieD. PrieA. Lillo-Le LouetM. CourbebaisseM. CourbebaisseM. CourbebaisseM. CourbebaisseM. CourbebaisseFrontiers Media S.A.articleinulin (PubChem CID: 16219508)safetyhypersensitivitypharmacovigilancesinistrinTherapeutics. PharmacologyRM1-950ENFrontiers in Pharmacology, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	inulin (PubChem CID: 16219508) safety hypersensitivity pharmacovigilance sinistrin Therapeutics. Pharmacology RM1-950
spellingShingle	inulin (PubChem CID: 16219508) safety hypersensitivity pharmacovigilance sinistrin Therapeutics. Pharmacology RM1-950 T-V. Bui C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye H. Ayari H. Ayari H. Ayari H. Ayari S. Baron S. Baron S. Baron S. Baron S. Baron S. Baron J-P. Bertocchio J-P. Bertocchio J-P. Bertocchio J-P. Bertocchio C. Bureau P. Davis A. Blanchard A. Blanchard A. Blanchard A. Blanchard A. Blanchard A. Blanchard P. Houillier P. Houillier P. Houillier P. Houillier P. Houillier P. Houillier D. Prie D. Prie D. Prie A. Lillo-Le Louet M. Courbebaisse M. Courbebaisse M. Courbebaisse M. Courbebaisse M. Courbebaisse Safety of Inulin and Sinistrin: Combining Several Sources for Pharmacovigilance Purposes
description	Introduction: Inulin and its analog sinistrin are fructose polymers used in the food and pharmaceutical industries. In 2018, The French National Agency for the Safety of Medicines and Health Products (ANSM) decided to withdraw products containing sinistrin and inulin due to several reports of serious hypersensitivity reactions, including a fatal outcome.Objective: To assess the safety of inulin and sinistrin use in France.Methods: We searched multiple sources to identify adverse reactions (ARs) to inulin or sinistrin: first, classical pharmacovigilance databases including the French Pharmacovigilance (FPVD) and the WHO Database (VigiBase); second, data from a clinical trial, MultiGFR; third, data regarding current use in an hospital. All potential ARs to inulin or sinistrin were analyzed with a focus on hypersensitivity reactions and relationships to batches of sinistrin.Results: From 1991 to 2018, 134 ARs to inulin or sinistrin were registered in the FPVD or VigiBase. Sixty-three cases (47%) were classified as serious, and 129 cases (96%) were hypersensitivity reactions. We found an association between a batch of sinistrin and the occurrence of hypersensitivity reactions. During the MultiGFR clinical trial, 7 patients (7/163 participants) had an Adverse reaction; of these, 4 were hypersensitivity reactions including one case of grade 4 anaphylactic shock. In the hospital, no ARs were observed. In the literature, ARs to inulin and sinistrin are very rarely reported and mostly benign.Conclusion: Most ARs to inulin and sinistrin are hypersensitivity reactions that appear to be associated with sinistrin batches.
format	article
author	T-V. Bui C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye H. Ayari H. Ayari H. Ayari H. Ayari S. Baron S. Baron S. Baron S. Baron S. Baron S. Baron J-P. Bertocchio J-P. Bertocchio J-P. Bertocchio J-P. Bertocchio C. Bureau P. Davis A. Blanchard A. Blanchard A. Blanchard A. Blanchard A. Blanchard A. Blanchard P. Houillier P. Houillier P. Houillier P. Houillier P. Houillier P. Houillier D. Prie D. Prie D. Prie A. Lillo-Le Louet M. Courbebaisse M. Courbebaisse M. Courbebaisse M. Courbebaisse M. Courbebaisse
author_facet	T-V. Bui C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye C. Prot-Bertoye H. Ayari H. Ayari H. Ayari H. Ayari S. Baron S. Baron S. Baron S. Baron S. Baron S. Baron J-P. Bertocchio J-P. Bertocchio J-P. Bertocchio J-P. Bertocchio C. Bureau P. Davis A. Blanchard A. Blanchard A. Blanchard A. Blanchard A. Blanchard A. Blanchard P. Houillier P. Houillier P. Houillier P. Houillier P. Houillier P. Houillier D. Prie D. Prie D. Prie A. Lillo-Le Louet M. Courbebaisse M. Courbebaisse M. Courbebaisse M. Courbebaisse M. Courbebaisse
author_sort	T-V. Bui
title	Safety of Inulin and Sinistrin: Combining Several Sources for Pharmacovigilance Purposes
title_short	Safety of Inulin and Sinistrin: Combining Several Sources for Pharmacovigilance Purposes
title_full	Safety of Inulin and Sinistrin: Combining Several Sources for Pharmacovigilance Purposes
title_fullStr	Safety of Inulin and Sinistrin: Combining Several Sources for Pharmacovigilance Purposes
title_full_unstemmed	Safety of Inulin and Sinistrin: Combining Several Sources for Pharmacovigilance Purposes
title_sort	safety of inulin and sinistrin: combining several sources for pharmacovigilance purposes
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/2a8e96dc6a91498e844eb4527d134946
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Safety of Inulin and Sinistrin: Combining Several Sources for Pharmacovigilance Purposes

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