Hypersensitivity to Inulin: A Rare and Mostly Benign Event

Bacchetta, Justine; Cochat, Pierre; Villard, François; Astier, Muriel; Vial, Thierry; Dubourg, Laurence; Hadj‐Aïssa, Aoumeur; Kassaï, Behrouz

doi:10.1053/j.ajkd.2008.06.008

Cited by 6 publications

(4 citation statements)

References 7 publications

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“…Of cases we identified, 47% were serious, including one fatal outcome and a serious anaphylactic shock with a favorable outcome following cardiopulmonary resuscitation. We thus did not come to the same conclusion as Bacchetta et al who found that “hypersensitivity to inulin is not serious” ( Bacchetta et al, 2008b ). These apparently contradictory results highlight the determining role of production in the occurrence of AR to drugs and diagnostic reagents.…”

Section: Discussioncontrasting

confidence: 63%

“…These are the most serious ARs observed in France over a period of more than 20 years with this reagent. In contrast, no serious ARs were identified by Bacchetta et al ( Bacchetta et al, 2008b ).…”

Section: Discussionmentioning

confidence: 87%

“…This geographical bias reflects the distribution of the measurement of GFR by inulin or sinistrin renal clearance in France, which were not used everywhere. The overrepresentation of cases in one center (Lyon) is explained by a specific study of the tolerance of inulin that was reported in 2008 ( Bacchetta et al, 2008b ).…”

Section: Discussionmentioning

confidence: 99%

“…Although inulin is widely used in the food industry, only a few cases of hypersensitivity to inulin have been reported in the literature. Bacchetta et al (2008b) systematically collected all cases of hypersensitivity reactions during GFR measurement of inulin clearance reported from January 1, 1998 to July 31, 2001 and from January 1, 2003 to December 31, 2006. For these two periods, 31 (0.49%) and 26 (0.43%) patients experienced AR, respectively.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

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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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Section: Discussioncontrasting

confidence: 63%

Section: Discussionmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

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Current awareness: Pharmacoepidemiology and drug safety

2009

Pharmacoepidemiology and Drug

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In order to keep subscribers up‐to‐date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of pharmacoepidemiology and drug safety. Each bibliography is divided into 23 sections: 1 Reviews; 2 General; 3 Anti‐infective Agents; 4 Cardiovascular System Agents; 5 CNS Depressive Agents; 6 Non‐steroidal Anti‐inflammatory Agents; 7 CNS Agents; 8 Anti‐neoplastic Agents; 9 Haematological Agents; 10 Neuroregulator‐Blocking Agents; 11 Dermatological Agents; 12 Immunosuppressive Agents; 13 Autonomic Agents; 14 Respiratory System Agents; 15 Neuromuscular Agents; 16 Reproductive System Agents; 17 Gastrointestinal System Agents; 18 Anti‐inflammatory Agents ‐ Steroidal; 19 Teratogens/fetal exposure; 20 Antidiabetic Agents; 21 Contrast Agents; 22 Bone Conservation Agents; 23 Others. Within each section, articles are listed in alphabetical order with respect to author. If, in the preceding period, no publications are located relevant to any one of these headings, that section will be omitted.

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Inulin-g-poly-D,L-lactide, a sustainable amphiphilic copolymer for nano-therapeutics

Sardo

Mencherini

Tommasino

et al. 2022

Drug Deliv. and Transl. Res.

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Cancer therapies started to take a big advantage from new nanomedicines on the market. Since then, research tried to better understand how to maximize efficacy while maintaining a high safety profile. Polyethylene glycol (PEG), the gold standard for nanomedicines coating design, is a winning choice to ensure a long circulation and colloidal stability, while in some cases, patients could develop PEG-directed immunoglobulins after the first administration. This lead to a phenomenon called accelerated blood clearance (ABC effect), and it is correlated with clinical failure because of the premature removal of the nanosystem from the circulation by immune mechanism. Therefore, alternatives to PEG need to be found. Here, looking at the backbone structural analogy, the hydrophilicity, flexibility, and its GRAS status, the natural polysaccharide inulin (INU) was investigated as PEG alternative. In particular, the first family of Inulin-g-poly-D,L-lactide amphiphilic copolymers (INU-PLAs) was synthesized. The new materials were fully characterized from the physicochemical point of view (solubility, 1D and 2D NMR, FT-IR, UV–Vis, GPC, DSC) and showed interesting hybrid properties compared to precursors. Moreover, their ability in forming stable colloids and to serve as a carrier for doxorubicin were investigated and compared with the already well-known and well-characterized PEGylated counterpart, polyethylene glycol-b-poly-D,L-lactide (PEG-PLA). This preliminary investigation showed INU-PLA to be able to assemble in nanostructures less than 200 nm in size and capable of loading doxorubicin with an encapsulation efficiency in the same order of magnitude of PEG-PLA analogues. Graphical abstract

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Hypersensitivity to Inulin: A Rare and Mostly Benign Event

Cited by 6 publications

References 7 publications

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

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

Current awareness: Pharmacoepidemiology and drug safety

Inulin-g-poly-D,L-lactide, a sustainable amphiphilic copolymer for nano-therapeutics

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