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Adverse reactions with levamisole vary according to its indications and misuse: A systematic pharmacovigilance study

Levamisole was initially prescribed for the treatment of intestinal worms. Because of immunomodulatory properties, levamisole has been used in inflammatory pathologies and in cancers in association with 5‐fluorouracil. Levamisole is misused as a cocaine adulterant. Post‐marketing reports have implic...

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Autores principales: Campillo, Jérémy T., Eiden, Céline, Boussinesq, Michel, Pion, Sébastien D. S., Faillie, Jean‐Luc, Chesnais, Cédric B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9293185/
https://www.ncbi.nlm.nih.gov/pubmed/34390273
http://dx.doi.org/10.1111/bcp.15037
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author Campillo, Jérémy T.
Eiden, Céline
Boussinesq, Michel
Pion, Sébastien D. S.
Faillie, Jean‐Luc
Chesnais, Cédric B.
author_facet Campillo, Jérémy T.
Eiden, Céline
Boussinesq, Michel
Pion, Sébastien D. S.
Faillie, Jean‐Luc
Chesnais, Cédric B.
author_sort Campillo, Jérémy T.
collection PubMed
description Levamisole was initially prescribed for the treatment of intestinal worms. Because of immunomodulatory properties, levamisole has been used in inflammatory pathologies and in cancers in association with 5‐fluorouracil. Levamisole is misused as a cocaine adulterant. Post‐marketing reports have implicated levamisole in the occurrence of adverse drug reactions (ADRs) and its use is now limited in Europe and North America. In contrast, all other parts of the World continue to use single‐dose levamisole as an anthelmintic. The aim of this study was to identify ADRs reported after levamisole exposure in VigiBase, the World Health Organisation's pharmacovigilance database, and analyse their frequency compared to other drugs and according to levamisole type of use. METHODS: All levamisole‐related ADRs were extracted from VigiBase. Disproportionality analyses were conducted to investigate psychiatric, hepatobiliary, renal, vascular, nervous, blood, skin, cardiac, musculoskeletal and general ADRs associated with levamisole and other drugs exposure. In secondary analyses, we compared the frequency of ADRs between levamisole and mebendazole and between levamisole type of use. RESULTS: Among the 1763 levamisole‐related ADRs identified, psychiatric disorders (reporting odds ratio with 95% confidence intervals: 1.4 [1.2–2.6]), hepatobiliary disorders (2.4 [1.9–4.3]), vasculitis (6.5 [4.1–10.6]), encephalopathy (22.5 [17.4–39.9]), neuropathy (4.3 [2.9–7.1]), haematological disorders, mild rashes and musculoskeletal disorders were more frequently reported with levamisole than with other drug. The majority of levamisole‐related ADRs occurred when the drug was administrated for a non–anti‐infectious indication. CONCLUSION: The great majority of the levamisole‐related ADRs concerned its immunomodulatory indication and multiple‐dose regimen. Our results suggest that single‐dose treatments for anthelmintic action have a good safety profile.
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spelling pubmed-92931852022-07-20 Adverse reactions with levamisole vary according to its indications and misuse: A systematic pharmacovigilance study Campillo, Jérémy T. Eiden, Céline Boussinesq, Michel Pion, Sébastien D. S. Faillie, Jean‐Luc Chesnais, Cédric B. Br J Clin Pharmacol Original Articles Levamisole was initially prescribed for the treatment of intestinal worms. Because of immunomodulatory properties, levamisole has been used in inflammatory pathologies and in cancers in association with 5‐fluorouracil. Levamisole is misused as a cocaine adulterant. Post‐marketing reports have implicated levamisole in the occurrence of adverse drug reactions (ADRs) and its use is now limited in Europe and North America. In contrast, all other parts of the World continue to use single‐dose levamisole as an anthelmintic. The aim of this study was to identify ADRs reported after levamisole exposure in VigiBase, the World Health Organisation's pharmacovigilance database, and analyse their frequency compared to other drugs and according to levamisole type of use. METHODS: All levamisole‐related ADRs were extracted from VigiBase. Disproportionality analyses were conducted to investigate psychiatric, hepatobiliary, renal, vascular, nervous, blood, skin, cardiac, musculoskeletal and general ADRs associated with levamisole and other drugs exposure. In secondary analyses, we compared the frequency of ADRs between levamisole and mebendazole and between levamisole type of use. RESULTS: Among the 1763 levamisole‐related ADRs identified, psychiatric disorders (reporting odds ratio with 95% confidence intervals: 1.4 [1.2–2.6]), hepatobiliary disorders (2.4 [1.9–4.3]), vasculitis (6.5 [4.1–10.6]), encephalopathy (22.5 [17.4–39.9]), neuropathy (4.3 [2.9–7.1]), haematological disorders, mild rashes and musculoskeletal disorders were more frequently reported with levamisole than with other drug. The majority of levamisole‐related ADRs occurred when the drug was administrated for a non–anti‐infectious indication. CONCLUSION: The great majority of the levamisole‐related ADRs concerned its immunomodulatory indication and multiple‐dose regimen. Our results suggest that single‐dose treatments for anthelmintic action have a good safety profile. John Wiley and Sons Inc. 2021-09-15 2022-03 /pmc/articles/PMC9293185/ /pubmed/34390273 http://dx.doi.org/10.1111/bcp.15037 Text en © 2021 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Campillo, Jérémy T.
Eiden, Céline
Boussinesq, Michel
Pion, Sébastien D. S.
Faillie, Jean‐Luc
Chesnais, Cédric B.
Adverse reactions with levamisole vary according to its indications and misuse: A systematic pharmacovigilance study
title Adverse reactions with levamisole vary according to its indications and misuse: A systematic pharmacovigilance study
title_full Adverse reactions with levamisole vary according to its indications and misuse: A systematic pharmacovigilance study
title_fullStr Adverse reactions with levamisole vary according to its indications and misuse: A systematic pharmacovigilance study
title_full_unstemmed Adverse reactions with levamisole vary according to its indications and misuse: A systematic pharmacovigilance study
title_short Adverse reactions with levamisole vary according to its indications and misuse: A systematic pharmacovigilance study
title_sort adverse reactions with levamisole vary according to its indications and misuse: a systematic pharmacovigilance study
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9293185/
https://www.ncbi.nlm.nih.gov/pubmed/34390273
http://dx.doi.org/10.1111/bcp.15037
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