| アブストラクト | 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. |
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| 投稿者 | Bui, T-V; Prot-Bertoye, C; Ayari, H; Baron, S; Bertocchio, J-P; Bureau, C; Davis, P; Blanchard, A; Houillier, P; Prie, D; Lillo-Le Louet, A; Courbebaisse, M |
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| 組織名 | Assistance Publique-Hopitaux de Paris, Centre Regional de Pharmacovigilance,;Hopital Europeen Georges Pompidou, Paris, France.;Assistance Publique-Hopitaux de Paris, Hopital Europeen Georges Pompidou, Service;de Physiologie, Paris, France.;Centre de Reference des Maladies Renales Hereditaires de l'Enfant et de l'Adulte;(MARHEA), Paris, France.;Centre de Reference des Maladies Rares du Calcium et du Phosphate, Paris, France.;Centre de Recherche des Cordeliers, INSERM, Sorbonne Universite, Universite de;Paris, Paris, France.;CNRS ERL 8228-Laboratoire de Physiologie Renale et Tubulopathies, Paris, France.;Faculte de Medecine, Universite de Paris, Paris, France.;Assistance Publique Hopitaux des Hopitaux de Paris, Hopital Europeen;Georges-Pompidou, Centre d'investigation Clinique, Paris, France.;Institut National de la Sante et de la Recherche Medicale, Paris, France.;Service des Explorations Fonctionnelles, Hopital Necker, APHP Centre-Universite;de Paris, Paris, France.;INEM Unite Inserm U1151, Paris, France. |
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