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Renault)",{"experts":14},{"seo_content":1320,"id":1322,"name":1323,"slug":1324,"parentId":1051,"lang":12,"_count":1325},[1321],{"page_slug":7},"cmkzhkuvq0039ulbcrwk28w30","Systèmes de Navigation","systemes-navigation",{"experts":14},{"seo_content":1327,"id":1330,"name":1331,"slug":1329,"parentId":1051,"lang":12,"_count":1332},[1328],{"page_slug":1329},"diagnostic","cm6y2pf1v0029frvx2t31ub3s","Diagnostic Auto",{"experts":14},{"seo_content":1334,"id":1336,"name":1337,"slug":1338,"parentId":1051,"lang":12,"_count":1339},[1335],{"page_slug":7},"cmkzhlfhr00mfulbcxgzuda3q","Voitures Utilitaires","voitures-utilitaires",{"experts":14},{"seo_content":1341,"id":1343,"name":1344,"slug":1345,"parentId":1051,"lang":12,"_count":1346},[1342],{"page_slug":7},"cmkzhl9wo00fpulbcblvz0p0f","Voitures Hybrides","voitures-hybrides",{"experts":14},{"seo_content":1348,"id":1350,"name":1351,"slug":1352,"parentId":1051,"lang":12,"_count":1353},[1349],{"page_slug":7},"cmkzhkzmk008zulbcb5miba2v","Réparation Skoda","reparation-skoda",{"experts":14},{"seo_content":1355,"id":1357,"name":1358,"slug":1359,"parentId":1051,"lang":12,"_count":1360},[1356],{"page_slug":7},"cmkzhktgd001julbc1x5jsi7d","Audio et Hi-Fi","audio-hifi",{"experts":14},{"seo_content":1362,"id":1365,"name":1366,"slug":1364,"parentId":1051,"lang":12,"_count":1367},[1363],{"page_slug":1364},"moto-cross","cm6y2pf230035frvx970a6ohb","Moto Cross",{"experts":14},{"seo_content":1369,"id":1371,"name":1372,"slug":1373,"parentId":1051,"lang":12,"_count":1374},[1370],{"page_slug":7},"cmkzhlfct00m9ulbcd7jplpr9","Réparation Volkswagen","reparation-volkswagen",{"experts":14},{"seo_content":1376,"id":1379,"name":1380,"slug":1378,"parentId":1051,"lang":12,"_count":1381},[1377],{"page_slug":1378},"carrossiers","cm6y2pf20002pfrvx8lko5fi1","Réparation 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: Prescrire demande le retrait d'un médicament cardiaque dangereux","Le 9 mars 2026, la revue médicale indépendante Prescrire a publié une lettre ouverte demandant le retrait du nicorandil (Ikorel) du marché français, qualifiant ce médicament contre l'angine de poitrin","Le 9 mars 2026, la revue médicale indépendante Prescrire a publié une lettre ouverte demandant le retrait du nicorandil (Ikorel) du marché français, qualifiant ce médicament contre l'angine de poitrine de \"plus dangereux qu'utile\". Cette alerte intervient après des années de signalements d'effets secondaires graves, dont des ulcérations sévères ayant entraîné des décès. Environ 71 000 patients français prennent actuellement ce traitement.\n\n## Une demande de retrait officielle adressée aux autorités sanitaires\n\nDans sa lettre ouverte publiée le 9 mars 2026, Prescrire interpelle directement l'Agence nationale de sécurité du médicament (ANSM) et la Haute Autorité de Santé (HAS). La revue médicale réclame l'arrêt immédiat de la commercialisation du nicorandil en France. Prescrit pour traiter l'angor (douleurs thoraciques liées à une insuffisance d'oxygénation du muscle cardiaque), ce médicament reste remboursé à 65% par l'Assurance maladie. En 2024, près de 900 000 boîtes ont été remboursées sur le territoire français.\n\nLe nicorandil appartient à une classe de médicaments appelés activateurs des canaux potassiques. Son mécanisme d'action repose sur deux effets complémentaires : la dilatation des artères coronaires pour améliorer l'apport sanguin au cœur, et la réduction de la charge de travail cardiaque. Cette double action devait théoriquement offrir un avantage dans le traitement de l'angine de poitrine stable.\n\n## Des cas graves documentés par la pharmacovigilance française\n\nEntre 2017 et 2024, les centres de pharmacovigilance français ont recensé 62 cas d'ulcérations graves causées par le nicorandil. Ces lésions peuvent toucher la peau et les muqueuses, notamment au niveau digestif, génital ou buccal. Le risque le plus préoccupant concerne les perforations d'organes, qui ont provoqué des décès chez certains patients. Selon les données de Vidal, environ 26% des patients sous nicorandil développent des ulcérations gastro-intestinales.\n\nLes ulcérations observées présentent des caractéristiques particulièrement problématiques. Au niveau cutané, elles se manifestent par des plaies chroniques qui ne cicatrisent pas malgré les soins locaux habituels. Ces lésions peuvent apparaître sur les jambes, les pieds ou d'autres zones du corps. Au niveau de la muqueuse buccale, des aphtes géants et récidivants ont été signalés, rendant l'alimentation difficile et douloureuse.\n\nLes complications digestives représentent le danger le plus grave. Des ulcérations œsophagiennes, gastriques et intestinales ont été rapportées, avec un risque de perforation pouvant conduire à une péritonite. Ces perforations digestives nécessitent souvent une intervention chirurgicale d'urgence. Les ulcérations génitales, bien que moins fréquentes, affectent significativement la qualité de vie des patients concernés.\n\nLa particularité du nicorandil réside dans le délai d'apparition de ces effets indésirables. Les ulcérations peuvent survenir plusieurs mois, voire plusieurs années après le début du traitement. Ce décalage temporel a longtemps rendu difficile l'identification du médicament comme cause directe des lésions.\n\n## Quels symptômes doivent alerter immédiatement\n\nLes patients traités par nicorandil doivent consulter en urgence s'ils présentent des ulcérations cutanées persistantes, des douleurs abdominales intenses, des vomissements avec sang, ou des selles noires. D'autres effets indésirables incluent des bouffées de chaleur, des palpitations, des migraines et des vertiges. Toute plaie qui ne cicatrise pas normalement nécessite une évaluation médicale rapide. Si vous prenez du nicorandil depuis plusieurs mois ou années, un bilan avec \u003Ca href=\"\u002Ffr\u002Fmedecins\u002Fcardiologues\">un cardiologue sur Expert Zoom\u003C\u002Fa> permet d'évaluer le rapport bénéfice-risque de votre traitement.\n\nLes signes d'alerte varient selon la localisation des ulcérations. Pour les atteintes digestives, une vigilance accrue s'impose en cas de douleurs abdominales persistantes, de difficultés à avaler, de perte de poids inexpliquée ou de fatigue intense pouvant signaler une anémie. Les selles noires (méléna) ou les vomissements sanglants constituent des urgences médicales absolues.\n\nPour les lésions cutanées, toute plaie apparue sans traumatisme évident et qui ne montre aucun signe de cicatrisation après deux semaines doit faire l'objet d'une consultation. Les ulcères buccaux persistants au-delà de trois semaines, particulièrement s'ils s'accompagnent de douleurs importantes, nécessitent également une évaluation.\n\n## Pourquoi Prescrire juge ce médicament trop dangereux\n\nL'efficacité du nicorandil dans le traitement de l'angor n'a jamais été démontrée de manière satisfaisante pour réduire les événements cardiovasculaires graves comme l'infarctus ou les accidents vasculaires cérébraux. Face à des risques documentés d'ulcérations potentiellement mortelles, la balance bénéfice-risque apparaît défavorable selon Prescrire. D'autres traitements de l'angine de poitrine, mieux évalués et moins dangereux, existent sur le marché français.\n\nLes essais cliniques disponibles sur le nicorandil n'ont pas démontré de réduction significative de la mortalité cardiovasculaire. L'étude IONA, principale référence sur ce médicament, a montré des résultats modestes qui ne compensent pas les risques documentés. En comparaison, d'autres classes thérapeutiques utilisées dans l'angor ont prouvé leur capacité à prévenir les complications graves.\n\n## Que faire si vous êtes sous nicorandil\n\nNe stoppez jamais un traitement cardiaque sans avis médical. Si vous prenez du nicorandil, planifiez une consultation avec votre cardiologue pour discuter des alternatives thérapeutiques. Votre médecin évaluera votre situation individuelle et pourra proposer d'autres options comme les bêtabloquants, les inhibiteurs calciques ou les dérivés nitrés. Cette réévaluation est particulièrement importante si vous avez déjà présenté des ulcérations cutanées ou digestives depuis le début du traitement.\n\nLors de cette consultation, préparez une liste de tous vos symptômes actuels, même ceux qui semblent mineurs. Mentionnez toute plaie ou lésion apparue depuis le début du traitement, même si elle a disparu entre-temps. Apportez vos derniers examens cardiaques pour faciliter la décision thérapeutique.\n\nLes alternatives au nicorandil dépendent de votre profil cardiaque spécifique. Les bêtabloquants réduisent le travail du cœur et ont prouvé leur efficacité pour diminuer les événements cardiovasculaires. Les inhibiteurs calciques dilatent les artères coronaires sans le risque ulcératif du nicorandil. Les dérivés nitrés, utilisés depuis des décennies, restent une option éprouvée pour soulager l'angine de poitrine.\n\nCertains patients nécessitent une transition progressive entre les traitements. Votre cardiologue établira un protocole adapté pour éviter toute décompensation cardiaque pendant le changement de médicament. Un suivi rapproché sera programmé pour vérifier l'efficacité du nouveau traitement.\n\n## Contexte réglementaire et perspectives\n\nL'ANSM et la HAS n'ont pas encore réagi officiellement à la demande de Prescrire. Le nicorandil reste commercialisé en France sous le nom d'Ikorel et ses génériques. La revue Prescrire, reconnue pour son indépendance et son expertise en évaluation des médicaments, a déjà obtenu par le passé le retrait ou la restriction d'autres molécules jugées dangereuses. Les prochaines semaines devraient clarifier la position des autorités sanitaires françaises face à cette alerte.\n\nLe processus de réévaluation par les autorités sanitaires peut prendre plusieurs mois. L'ANSM dispose d'un délai réglementaire pour analyser les données de pharmacovigilance et consulter ses commissions d'experts. La HAS, de son côté, devra revoir les conditions de remboursement si des restrictions d'usage sont décidées.\n\nD'autres pays européens ont déjà pris position sur le nicorandil. Certaines agences du médicament ont renforcé les mises en garde sur les notices, tandis que d'autres envisagent des restrictions d'indication. La coordination européenne via l'Agence européenne des médicaments (EMA) pourrait aboutir à une harmonisation des recommandations dans les prochains mois.\n\n---\n\n**Avertissement médical**: Cet article présente des informations à caractère médical et sanitaire. Il ne remplace pas une consultation médicale personnalisée. Ne modifiez jamais votre traitement sans l'avis de votre médecin. En cas de symptômes inquiétants, consultez un professionnel de santé en urgence.\n\n**Sources**: Lettre ouverte de Prescrire à l'ANSM et à la HAS (9 mars 2026), données de pharmacovigilance française 2017-2024, \u003Ca href=\"https:\u002F\u002Fwww.prescrire.org\" target=\"_blank\" rel=\"nofollow noopener\">Prescrire.org\u003C\u002Fa>.","https:\u002F\u002Fpub-bdebbd2dad294475a2da0eb657815b6b.r2.dev\u002Fhero\u002F1ee0ac36f4c8.webp","Patient français examinant une notice de médicament avec un pharmacien en blouse blanche","PUBLISHED","fr","b96d7271-aa4f-47f0-896b-bc3ddc2b45ed","Nicorandil retiré ? L'alerte Prescrire | Expert Zoom","Prescrire demande le retrait du nicorandil (Ikorel) jugé dangereux. 71 000 patients concernés. Consultez un cardiologue pour adapter votre traitement.","nicorandil médicament retrait alerte sécurité","nicorandil médicament","FR","1ee0ac36f4c8","9cc87197-5408-43dc-9de5-d740868a64f4",765,"PASS","Submitted and indexed","2026-05-22T17:19:32.000Z","2026-06-03T13:31:29.971Z",2.85,"needs_improvement",1.58,"good","2026-06-01T02:46:37.652Z","2026-03-20T23:00:03.041Z","2026-03-20T23:00:03.042Z","2026-06-25T17:12:17.496Z",{"id":640,"name":641,"slug":642,"parentId":474,"parent":1482},{"id":474,"name":1444,"slug":1445},{"id":1460,"first_name":1484,"name":1485,"slug":1486,"specialty":1487,"picture":1488,"region":1489},"Ines","Moutaouakil","ines-moutaouakil","Expert en Santé","ines",{"code":12,"country":1490},{"code":1465,"name":1491},"France",[]]