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

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          Abstract

          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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          Most cited references71

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          Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma.

          C MOERTEL, T Fleming, J S Macdonald … (1990)
          Twelve hundred ninety-six patients with resected colon cancer that either was locally invasive (Stage B2) or had regional nodal involvement (Stage C) were randomly assigned to observation or to treatment for one year with levamisole combined with fluorouracil. Patients with Stage C disease could also be randomly assigned to treatment with levamisole alone. The median follow-up time at this writing is 3 years (range, 2 to 5 1/2). Among the patients with Stage C disease, therapy with levamisole plus fluorouracil reduced the risk of cancer recurrence by 41 percent (P less than 0.0001). The overall death rate was reduced by 33 percent (P approximately 0.006). Treatment with levamisole alone had no detectable effect. The results in the patients with Stage B2 disease were equivocal and too preliminary to allow firm conclusions. Toxic effects of levamisole alone were infrequent, usually consisting of mild nausea with occasional dermatitis or leukopenia, and those of levamisole plus fluorouracil were essentially the same as those of fluorouracil alone--i.e., nausea, vomiting, stomatitis, diarrhea, dermatitis, and leukopenia. These reactions were usually not severe and did not greatly impede patients' compliance with their regimen. We conclude that adjuvant therapy with levamisole and fluorouracil should be standard treatment for Stage C colon carcinoma. Since most patients in our study were treated by community oncologists, this approach should be readily adaptable to conventional medical practice.
          Article 0 comments Cited 222 times – based on 0 reviews     Review now
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            A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions.

            Eugène Van Puijenbroek, Andrew Bate, Hubert G. M. Leufkens … (2002)
            A continuous systematic review of all combinations of drugs and suspected adverse reactions (ADRs) reported to a spontaneous reporting system, is necessary to optimize signal detection. To focus attention of human reviewers, quantitative procedures can be used to sift data in different ways. In various centres, different measures are used to quantify the extent to which an ADR is reported disproportionally to a certain drug compared to the generality of the database. The objective of this study is to examine the level of concordance of the various estimates to the measure used by the WHO Collaborating Centre for International ADR monitoring, the information component (IC), when applied to the dataset of the Netherlands Pharmacovigilance Foundation Lareb. The Reporting Odds Ratio--1.96 standard errors (SE), proportional reporting ratio--1.96 SE, Yule's Q--1.96 SE, the Poisson probability and Chi-square test of all 17,330 combinations were compared with the IC minus 2 standard deviations. Additionally, the concordance of the various tests, in respect to the number of reports per combination, was examined. In general, sensitivity was high in respect to the reference measure when a combination of point- and precision estimate was used. The concordance increased dramatically when the number of reports per combination increased. This study shows that the different measures used are broadly comparable when four or more cases per combination have been collected.
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              VigiBase, the WHO Global ICSR Database System: Basic Facts

              Marie Lindquist (2008)
              Article 0 comments Cited 181 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Jérémy T. Campillo:
                ORCID: https://orcid.org/0000-0002-4400-5204
                jeremy.campillo@ird.fr
                Journal
                Journal ID (nlm-ta): Br J Clin Pharmacol
                Journal ID (iso-abbrev): Br J Clin Pharmacol
                Journal ID (doi): 10.1111/(ISSN)1365-2125
                Journal ID (publisher-id): BCP
                Title: British Journal of Clinical Pharmacology
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Print): 0306-5251
                ISSN (Electronic): 1365-2125
                Publication date (Electronic): 15 September 2021
                Publication date (Print): March 2022
                Publication date PMC-release: 15 September 2021
                Volume: 88
                Issue: 3 ( doiID: 10.1111/bcp.v88.3 )
                Pages: 1094-1106
                Affiliations
                [ 1 ] UMI 233 TransVIHMI, Université de Montpellier, Institut de Recherche pour le Développement (IRD), INSERM Montpellier France
                [ 2 ] Department of medical pharmacology and toxicology CHU Montpellier Montpellier France
                [ 3 ] Desbrest Institute of Epidemiology and Public Health UMR UA11 INSERM University of Montpellier Montpellier France
                Author notes
                [*] [* ] Correspondence

                Jérémy T. Campillo, UMI 233 TransVIHMI, Université de Montpellier, Institut de Recherche pour le Développement (IRD), INSERM, INSERM Unité 1175, Montpellier, France.

                Email: jeremy.campillo@ 123456ird.fr

                Author information
                https://orcid.org/0000-0002-4400-5204
                Article
                Publisher ID: BCP15037
                DOI: 10.1111/bcp.15037
                PMC ID: 9293185
                PubMed ID: 34390273
                SO-VID: 08fcb584-3dd8-47d8-8f2d-9a40cdf838b9
                Copyright © © 2021 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.
                License:

                This is an open access article under the terms of the http://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.

                History
                Date revision received : 30 July 2021
                Date received : 23 April 2021
                Date accepted : 03 August 2021
                Page count
                Figures: 0, Tables: 5, Pages: 13, Words: 9100
                Categories
                Subject: Original Article
                Subject: Original Articles
                Custom metadata
                source-schema-version-number 2.0
                cover-date March 2022
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.7 mode:remove_FC converted:18.07.2022

                ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine
                Keywords: adverse drug reactions,disproportionality,levamisole,pharmacovigilance
                Data availability:
                ScienceOpen disciplines: Pharmacology & Pharmaceutical medicine
                Keywords: adverse drug reactions, disproportionality, levamisole, pharmacovigilance

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