{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T11:06:02Z","timestamp":1774004762143,"version":"3.50.1"},"reference-count":49,"publisher":"EDP Sciences","issue":"3","license":[{"start":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T00:00:00Z","timestamp":1773964800000},"content-version":"vor","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Med Sci (Paris)"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:p>L\u2019efficacit\u00e9 des m\u00e9dicaments est \u00e9valu\u00e9e par les essais cliniques. Cependant, ceux-ci ne sont pas con\u00e7us pour identifier les effets ind\u00e9sirables, en particulier lorsqu\u2019ils sont rares. Ceci justifie un syst\u00e8me robuste de pharmacovigilance, pour les \u00e9valuer apr\u00e8s la commercialisation des m\u00e9dicaments, compl\u00e9t\u00e9 au besoin par des \u00e9tudes pharmaco\u00e9pid\u00e9miologiques. Les b\u00e9n\u00e9fices des m\u00e9dicaments s\u2019expriment en valeur relative ou absolue, et varient en fonction du risque associ\u00e9 \u00e0 la maladie (sa s\u00e9v\u00e9rit\u00e9, son risque de complications ou de progression) et de son incidence pour le b\u00e9n\u00e9fice populationnel. Ce n\u2019est pas le cas des effets ind\u00e9sirables, qui d\u00e9pendent des caract\u00e9ristiques intrins\u00e8ques du m\u00e9dicament et de la population trait\u00e9e. Dans ce contexte, peut-on r\u00e9ellement mettre en balance les avantages et les risques des m\u00e9dicaments ? L\u2019exp\u00e9rience de la Covid-19 illustre la complexit\u00e9 de cette notion. Elle met clairement en \u00e9vidence la n\u00e9cessit\u00e9 d\u2019une analyse conjointe des essais cliniques, du suivi de pharmacovigilance, des \u00e9tudes pharmaco\u00e9pid\u00e9miologiques et de la d\u00e9tection des interactions m\u00e9dicamenteuses potentielles. Enfin, l\u2019acculturation du grand public \u00e0 l\u2019\u00e9valuation de l\u2019efficacit\u00e9 et de la s\u00e9curit\u00e9 des m\u00e9dicaments est indispensable pour permettre \u00e0 chacun d\u2019interpr\u00e9ter correctement cette notion complexe de balance b\u00e9n\u00e9fices-risques, d\u2019\u00e9viter les simplifications, et de lutter contre la d\u00e9sinformation.<\/jats:p>","DOI":"10.1051\/medsci\/2026040","type":"journal-article","created":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T08:54:57Z","timestamp":1773996897000},"page":"295-305","source":"Crossref","is-referenced-by-count":0,"title":["\u00c9valuer la balance b\u00e9n\u00e9fices-risques des m\u00e9dicaments"],"prefix":"10.1051","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0787-1469","authenticated-orcid":false,"given":"Jean-Luc","family":"Cracowski","sequence":"first","affiliation":[{"name":"Universit\u00e9 Grenoble Alpes, Inserm U1300, Centre r\u00e9gional de pharmacovigilance de Grenoble","place":["France"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mathieu","family":"Molimard","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Bordeaux","place":["France"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vincent","family":"Richard","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Rouen Normandie, Inserm, ENVI UMR1096, CHU de Rouen, d\u00e9partement de pharmacologie","place":["France"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthieu","family":"Roustit","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Grenoble Alpes, Inserm U1300, Centre d\u2019investigation clinique de Grenoble"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8427-8573","authenticated-orcid":false,"given":"Charles","family":"Khouri","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Grenoble Alpes, Inserm U1300, Centre r\u00e9gional de pharmacovigilance de Grenoble","place":["France"]},{"name":"Universit\u00e9 Grenoble Alpes, Inserm U1300, Centre d\u2019investigation clinique de Grenoble"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"250","published-online":{"date-parts":[[2026,3,20]]},"reference":[{"key":"R1","doi-asserted-by":"crossref","first-page":"e72","DOI":"10.1016\/S2589-7500(20)30318-6","volume":"3","author":"Mackey","year":"2021","journal-title":"Lancet Digit Health"},{"key":"R2","unstructured":"Molimard M, Costagliola D, Maisonneuve H. Information en sant\u00e9. Bilan des forces et des faiblesses. Recommandations pour une strat\u00e9gie nationale d\u2019information et de lutte contre la d\u00e9sinformation en sant\u00e9. 2026 ; https:\/\/sante.gouv.fr\/IMG\/pdf\/rapport_information.pdf."},{"key":"R3","doi-asserted-by":"crossref","first-page":"451","DOI":"10.1016\/0091-7435(86)90024-1","volume":"15","author":"Flay","year":"1986","journal-title":"Prev Med"},{"key":"R4","doi-asserted-by":"crossref","first-page":"857","DOI":"10.1002\/cpt.1347","volume":"105","author":"Selker","year":"2019","journal-title":"Clin Pharmacol Ther"},{"key":"R5","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1051\/medsci\/2024036","volume":"40","author":"Hardelin","year":"2024","journal-title":"Med Sci (Paris)"},{"key":"R6","doi-asserted-by":"crossref","first-page":"e1004","DOI":"10.1136\/bmj.e1004","volume":"344","author":"Sedgwick","year":"2012","journal-title":"BMJ"},{"key":"R7","doi-asserted-by":"crossref","first-page":"674","DOI":"10.1056\/NEJMsb1901642","volume":"382","author":"Collins","year":"2020","journal-title":"N Engl J Med"},{"key":"R8","doi-asserted-by":"crossref","first-page":"2603","DOI":"10.1056\/NEJMoa2034577","volume":"383","author":"Polack","year":"2020","journal-title":"N Engl J Med"},{"key":"R9","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1056\/NEJMoa2035389","volume":"384","author":"Baden","year":"2020","journal-title":"N Engl J Med"},{"key":"R10","unstructured":"Soci\u00e9t\u00e9 Fran\u00e7aise de Pharmacologie et de Th\u00e9rapeutique. Livre blanc. De la n\u00e9cessit\u00e9 de la m\u00e9thodologie dans l\u2019\u00e9valuation des m\u00e9dicaments. https:\/\/sfpt-fr.org\/livreblancmethodo\/index.htm"},{"key":"R11","doi-asserted-by":"crossref","first-page":"e26","DOI":"10.1016\/S1473-3099(20)30773-8","volume":"21","author":"Hodgson","year":"2021","journal-title":"Lancet Infect Dis"},{"key":"R12","doi-asserted-by":"crossref","first-page":"802","DOI":"10.1056\/NEJM199003223221203","volume":"322","author":"Riggs","year":"1990","journal-title":"N Engl J Med"},{"key":"R13","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1136\/bmjebm-2020-111493","volume":"27","author":"Sarri","year":"2022","journal-title":"BMJ Evid Based Med"},{"key":"R14","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1016\/j.therap.2018.11.015","volume":"74","author":"Sommet","year":"2019","journal-title":"Therapie"},{"key":"R15","doi-asserted-by":"crossref","first-page":"72","DOI":"10.1093\/ije\/31.1.72","volume":"31","author":"Furukawa","year":"2002","journal-title":"Int J Epidemiol"},{"key":"R16","doi-asserted-by":"crossref","first-page":"1728","DOI":"10.1056\/NEJM198806303182605","volume":"318","author":"Laupacis","year":"1988","journal-title":"N Engl J Med"},{"key":"R17","doi-asserted-by":"crossref","first-page":"e281","DOI":"10.1016\/S2666-5247(21)00119-1","volume":"2","author":"Correia","year":"2021","journal-title":"Lancet Microbe"},{"key":"R18","doi-asserted-by":"crossref","first-page":"e279","DOI":"10.1016\/S2666-5247(21)00069-0","volume":"2","author":"Olliaro","year":"2021","journal-title":"Lancet Microbe"},{"key":"R19","doi-asserted-by":"crossref","first-page":"12","DOI":"10.1111\/j.1742-7843.2006.pto_412.x","volume":"99","author":"Christensen","year":"2006","journal-title":"Basic Clin Pharmacol Toxicol"},{"key":"R20","doi-asserted-by":"crossref","first-page":"218","DOI":"10.1111\/fcp.12715","volume":"36","author":"Montastruc","year":"2022","journal-title":"Fundam Clin Pharmacol"},{"key":"R21","first-page":"100530","volume":"23","author":"Adams","year":"2023","journal-title":"Lancet Reg Health Am"},{"key":"R22","first-page":"2603","volume":"383","author":"Thomas","year":"2021","journal-title":"N Engl J Med"},{"key":"R23","doi-asserted-by":"crossref","first-page":"924","DOI":"10.1016\/S0140-6736(22)00152-0","volume":"399","author":"Feikin","year":"2022","journal-title":"Lancet"},{"key":"R24","unstructured":"CIOMS Cumulative Glossary, with a focus on Pharmacovigilance (version 2.1). Counc Int Organ Med Sci https:\/\/cioms.ch\/wpcontent\/uploads\/2023\/04\/CIOMSGlossary_v2.1_1stMay2023.pdf"},{"key":"R25","unstructured":"The use of the WHO-UMC system for standardised case causality assessment https:\/\/www.who.int\/docs\/default-source\/medicines\/pharmacovigilance\/whocausality-assessment.pdf"},{"key":"R26","doi-asserted-by":"crossref","first-page":"179","DOI":"10.1016\/j.therap.2016.02.010","volume":"71","author":"Miremont-Salam\u00e9","year":"2016","journal-title":"Therapie"},{"key":"R27","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1136\/ebmed-2017-110885","volume":"23","author":"Onakpoya","year":"2018","journal-title":"BMJ Evid Based Med"},{"key":"R28","doi-asserted-by":"crossref","first-page":"1366","DOI":"10.2105\/AJPH.2007.124537","volume":"98","author":"Berlin","year":"2008","journal-title":"Am J Public Health"},{"key":"R29","doi-asserted-by":"crossref","first-page":"1101","DOI":"10.1001\/jama.2021.1967","volume":"325","author":"Shimabukuro","year":"2021","journal-title":"JAMA"},{"key":"R30","doi-asserted-by":"crossref","first-page":"780","DOI":"10.1001\/jama.2021.0600","volume":"325","author":"Shimabukuro","year":"2021","journal-title":"JAMA"},{"key":"R31","doi-asserted-by":"crossref","first-page":"3633","DOI":"10.1038\/s41467-022-31401-5","volume":"13","author":"Le Vu","year":"2022","journal-title":"Nat Commun"},{"key":"R32","doi-asserted-by":"crossref","first-page":"161","DOI":"10.1080\/14740338.2024.2305707","volume":"23","author":"Salmon","year":"2024","journal-title":"Expert Opin Drug Saf"},{"key":"R33","doi-asserted-by":"crossref","first-page":"2092","DOI":"10.1056\/NEJMoa2104840","volume":"384","author":"Greinacher","year":"2021","journal-title":"N Engl J Med"},{"key":"R34","unstructured":"Shimabukuro T. COVID-19 Vaccine safety updates. CDC Gov 2021 ; https:\/\/stacks.cdc.gov\/view\/cdc\/108329"},{"key":"R35","doi-asserted-by":"crossref","first-page":"e0251918","DOI":"10.1371\/journal.pone.0251918","volume":"16","author":"Lo","year":"2021","journal-title":"PLoS One"},{"key":"R36","doi-asserted-by":"crossref","first-page":"2349","DOI":"10.1038\/s41467-021-22446-z","volume":"12","author":"Axfors","year":"2021","journal-title":"Nat Commun"},{"key":"R37","doi-asserted-by":"crossref","first-page":"509","DOI":"10.1016\/j.therap.2022.03.005","volume":"77","author":"Lemaitre","year":"2022","journal-title":"Therapie"},{"key":"R38","doi-asserted-by":"crossref","first-page":"531","DOI":"10.1016\/j.therap.2023.03.001","volume":"78","author":"Bihan","year":"2023","journal-title":"Therapie"},{"key":"R39","unstructured":"Benefit-risk methodology \u2013 European Medicines Agency. https:\/\/www.ema.europa.eu\/en\/documents\/report\/benefit-risk-methodology-project-work-package-2-report-applicability-current-tools-and-processes-regulatory-benefit-risk-assessment_en.pdf"},{"key":"R40","unstructured":"Benefit-Risk Assessment for New Drug and Biological Products. 2023. https:\/\/www.fda.gov\/ regulatory-information\/search-fda-guidance-documents\/benefit-risk-assessment-new-drug-and-biological-products"},{"key":"R41","unstructured":"Covid-19. Dr Chris Cates\u2019 EBM Website 2020. https:\/\/www.nntonline.net\/topics\/covid-19\/"},{"key":"R42","unstructured":"European Medicines Agency. Annex to Vaxzevria Art.5.3 \u2013 Visual risk contextualisation. https:\/\/www.ema.europa.eu\/en\/documents\/chmp-annex\/annex-vaxzevria-art53-visual-risk-contextualisation_en.pdf"},{"key":"R43","doi-asserted-by":"crossref","first-page":"471","DOI":"10.1161\/CIRCULATIONAHA.121.056135","volume":"144","author":"Bozkurt","year":"2021","journal-title":"Circulation"},{"key":"R44","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1016\/j.jclinepi.2021.03.018","volume":"137","author":"Buyse","year":"2021","journal-title":"J Clin Epidemiol"},{"key":"R45","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1093\/eurheartj\/ehr352","volume":"33","author":"Pocock","year":"2012","journal-title":"Eur Heart J"},{"key":"R46","doi-asserted-by":"crossref","first-page":"2417","DOI":"10.1001\/jama.2018.16865","volume":"320","author":"Chou","year":"2018","journal-title":"JAMA"},{"key":"R47","doi-asserted-by":"crossref","first-page":"389","DOI":"10.1111\/fcp.12564","volume":"34","author":"Larrouquere","year":"2020","journal-title":"Fundam Clin Pharmacol"},{"key":"R48","doi-asserted-by":"crossref","first-page":"232","DOI":"10.1038\/s41591-021-01661-7","volume":"28","author":"Ward","year":"2022","journal-title":"Nat Med"},{"key":"R49","doi-asserted-by":"crossref","first-page":"1049","DOI":"10.1007\/s40264-022-01220-0","volume":"45","author":"Khouri","year":"2022","journal-title":"Drug Saf"}],"container-title":["m\u00e9decine\/sciences"],"original-title":[],"link":[{"URL":"https:\/\/www.medecinesciences.org\/10.1051\/medsci\/2026040\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T08:56:09Z","timestamp":1773996969000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.medecinesciences.org\/10.1051\/medsci\/2026040"}},"subtitle":["Quelques le\u00e7ons de la Covid-19"],"short-title":[],"issued":{"date-parts":[[2026,3]]},"references-count":49,"journal-issue":{"issue":"3"},"alternative-id":["medsci20250149"],"URL":"https:\/\/doi.org\/10.1051\/medsci\/2026040","relation":{},"ISSN":["0767-0974","1958-5381"],"issn-type":[{"value":"0767-0974","type":"print"},{"value":"1958-5381","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3]]}}}