Medicines withdrawn in other countries due to safety problems, between 2014 and 2023, and their permanence in the Argentine market
Introduction: After the marketing approval of a medicine, pharmacovigilance monitoring must be carried out at an international level and the necessary measures must be adopted to reduce the risk that its use may present. Restrictive measures are not taken with the same speed in all countries and the...
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| Lenguaje: | Español |
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Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología
2025
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| Acceso en línea: | https://revistas.unc.edu.ar/index.php/med/article/view/46049 |
| Aporte de: |
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I10-R327-article-46049 |
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Universidad Nacional de Córdoba |
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Revista de la Facultad de Ciencias Médicas de Córdoba |
| language |
Español |
| format |
Artículo revista |
| topic |
safety-based drug withdrawals pharmacovigilance drug-related side effects and adverse reactions product surveillance postmarketing retirada de medicamento por seguridad farmacovigilancia efectos colaterales y reacciones adversas relacionados con medicamentos vigilancia de productos comercializados retirada de medicamento baseada em segurança farmacovigilância efeitos colaterais e reações adversas relacionados a medicamentos vigilância de produtos comercializados |
| spellingShingle |
safety-based drug withdrawals pharmacovigilance drug-related side effects and adverse reactions product surveillance postmarketing retirada de medicamento por seguridad farmacovigilancia efectos colaterales y reacciones adversas relacionados con medicamentos vigilancia de productos comercializados retirada de medicamento baseada em segurança farmacovigilância efeitos colaterais e reações adversas relacionados a medicamentos vigilância de produtos comercializados Caffaratti, Mariana Cañás, Martín Domosbian, Daniel Eduardo Giraudo, Emiliano González, Ana María Lorenzo, Andrea Núñez Montoya, Susana Núñez Rocha, María Teresa Traverso, María Luz Uema, Sonia Medicines withdrawn in other countries due to safety problems, between 2014 and 2023, and their permanence in the Argentine market |
| topic_facet |
safety-based drug withdrawals pharmacovigilance drug-related side effects and adverse reactions product surveillance postmarketing retirada de medicamento por seguridad farmacovigilancia efectos colaterales y reacciones adversas relacionados con medicamentos vigilancia de productos comercializados retirada de medicamento baseada em segurança farmacovigilância efeitos colaterais e reações adversas relacionados a medicamentos vigilância de produtos comercializados |
| author |
Caffaratti, Mariana Cañás, Martín Domosbian, Daniel Eduardo Giraudo, Emiliano González, Ana María Lorenzo, Andrea Núñez Montoya, Susana Núñez Rocha, María Teresa Traverso, María Luz Uema, Sonia |
| author_facet |
Caffaratti, Mariana Cañás, Martín Domosbian, Daniel Eduardo Giraudo, Emiliano González, Ana María Lorenzo, Andrea Núñez Montoya, Susana Núñez Rocha, María Teresa Traverso, María Luz Uema, Sonia |
| author_sort |
Caffaratti, Mariana |
| title |
Medicines withdrawn in other countries due to safety problems, between 2014 and 2023, and their permanence in the Argentine market |
| title_short |
Medicines withdrawn in other countries due to safety problems, between 2014 and 2023, and their permanence in the Argentine market |
| title_full |
Medicines withdrawn in other countries due to safety problems, between 2014 and 2023, and their permanence in the Argentine market |
| title_fullStr |
Medicines withdrawn in other countries due to safety problems, between 2014 and 2023, and their permanence in the Argentine market |
| title_full_unstemmed |
Medicines withdrawn in other countries due to safety problems, between 2014 and 2023, and their permanence in the Argentine market |
| title_sort |
medicines withdrawn in other countries due to safety problems, between 2014 and 2023, and their permanence in the argentine market |
| description |
Introduction: After the marketing approval of a medicine, pharmacovigilance monitoring must be carried out at an international level and the necessary measures must be adopted to reduce the risk that its use may present. Restrictive measures are not taken with the same speed in all countries and there are differences in withdrawal patterns.
Objectives: Identify medicines that have been withdrawn from marketing for safety reasons in countries with health reference agencies (SRA), between January 2014 and June 2023. Establish if these medicines were withdrawn from the market in Argentina.
Methodology: Search for information on SRA, National Administration of Food Drugs and Medical Technology (ANMAT) websites and secondary sources. For each medication withdrawn by any SRA, the validity of the marketing certificate and regulatory actions in Argentina were verified.
Results: In countries with SRA health agencies, 31 medications were withdrawn for safety reasons. Of these, in Argentina, 7 were identified with a valid marketing certificate, another 7 were withdrawn from the market mostly by the manufacturing laboratories, 14 were never marketed and no data was obtained for 3.
Conclusion: In Argentina, medications were identified that were withdrawn from other countries and continue to have a valid marketing certificate. The number of regulatory actions related to safety aspects in our country was lower than those of countries with SRA. It is necessary to strengthen the pharmacovigilance system, and for ANMAT to apply measures that reduce the risk associated with the use of the questioned medications. |
| publisher |
Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología |
| publishDate |
2025 |
| url |
https://revistas.unc.edu.ar/index.php/med/article/view/46049 |
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I10-R327-article-460492025-06-26T19:09:18Z Medicines withdrawn in other countries due to safety problems, between 2014 and 2023, and their permanence in the Argentine market Medicamentos retirados en otros países por problemas de seguridad, entre 2014 y 2023, y su permanencia en el mercado argentino Medicamentos retirados de outros países por problemas de segurança, entre 2014 e 2023, e sua permanência no mercado argentino Caffaratti, Mariana Cañás, Martín Domosbian, Daniel Eduardo Giraudo, Emiliano González, Ana María Lorenzo, Andrea Núñez Montoya, Susana Núñez Rocha, María Teresa Traverso, María Luz Uema, Sonia safety-based drug withdrawals pharmacovigilance drug-related side effects and adverse reactions product surveillance postmarketing retirada de medicamento por seguridad farmacovigilancia efectos colaterales y reacciones adversas relacionados con medicamentos vigilancia de productos comercializados retirada de medicamento baseada em segurança farmacovigilância efeitos colaterais e reações adversas relacionados a medicamentos vigilância de produtos comercializados Introduction: After the marketing approval of a medicine, pharmacovigilance monitoring must be carried out at an international level and the necessary measures must be adopted to reduce the risk that its use may present. Restrictive measures are not taken with the same speed in all countries and there are differences in withdrawal patterns. Objectives: Identify medicines that have been withdrawn from marketing for safety reasons in countries with health reference agencies (SRA), between January 2014 and June 2023. Establish if these medicines were withdrawn from the market in Argentina. Methodology: Search for information on SRA, National Administration of Food Drugs and Medical Technology (ANMAT) websites and secondary sources. For each medication withdrawn by any SRA, the validity of the marketing certificate and regulatory actions in Argentina were verified. Results: In countries with SRA health agencies, 31 medications were withdrawn for safety reasons. Of these, in Argentina, 7 were identified with a valid marketing certificate, another 7 were withdrawn from the market mostly by the manufacturing laboratories, 14 were never marketed and no data was obtained for 3. Conclusion: In Argentina, medications were identified that were withdrawn from other countries and continue to have a valid marketing certificate. The number of regulatory actions related to safety aspects in our country was lower than those of countries with SRA. It is necessary to strengthen the pharmacovigilance system, and for ANMAT to apply measures that reduce the risk associated with the use of the questioned medications. Introducción: Luego de la aprobación de comercialización de un medicamento, se debe realizar un seguimiento de farmacovigilancia a nivel internacional y adoptar medidas necesarias para reducir el riesgo que pueda presentar su uso. Las medidas restrictivas no se toman con la misma rapidez en todos los países y existen diferencias en los patrones de retiro. Objetivos: Identificar medicamentos que han sido retirados de su comercialización por razones de seguridad en países con agencias sanitarias de referencia (SRA), entre enero 2014 y junio 2023. Establecer si dichos medicamentos fueron retirados del mercado en Argentina. Metodología: Búsqueda de información en sitios web de SRA, Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT) y fuentes secundarias. Para cada medicamento retirado por alguna SRA, se constató la vigencia del certificado de comercialización y acciones regulatorias en Argentina. Resultados: En los países con agencias sanitarias SRA se retiraron 31 medicamentos por motivos de seguridad. De estos, en Argentina, se identificaron 7 con certificado de comercialización vigente, otros 7 fueron retirados del mercado en su mayoría por los laboratorios fabricantes, 14 nunca fueron comercializados y no se obtuvieron datos de 3. Conclusión: En Argentina se identificaron medicamentos que fueron retirados de otros países y continúan con registro vigente. La cantidad de acciones regulatorias relacionadas a aspectos de seguridad en nuestro país fue inferior a las de países con SRA. Es necesario fortalecer el sistema de farmacovigilancia, y que ANMAT aplique medidas que permitan disminuir el riesgo asociado al uso de los medicamentos cuestionados. Introdução: Após a aprovação de comercialização de um medicamento, o monitoramento da farmacovigilância deve ser realizado em nível internacional e devem ser adotadas as medidas necessárias para reduzir o risco que seu uso pode apresentar. As medidas restritivas não são tomadas com a mesma rapidez em todos os países e existem diferenças nos padrões de retirada. Objetivos: Identificar medicamentos que foram retirados de comercialização por motivos de segurança em países com agências de referência em saúde (SRA), entre janeiro de 2014 e junho de 2023. Estabelecer se tais medicamentos foram retirados do mercado na Argentina. Metodologia: Busca de informações nos sites da SRA, Administração Nacional de Alimentos, Medicamentos e Tecnologia Médica (ANMAT) e fontes secundárias. Para cada medicamento retirado por qualquer SRA, foi verificada a validade do certificado de comercialização e ações regulatórias na Argentina. Resultados: Nos países com agências de saúde SRA, 31 medicamentos foram retirados por razões de segurança. Destes, na Argentina, 7 foram identificados com um certificado de comercialização válido, outros 7 foram retirados do mercado principalmente pelos laboratórios fabricantes, 14 nunca foram comercializados e não foram obtidos dados para 3. Conclusão: Na Argentina foram identificados medicamentos que foram retirados de outros países e continuam com registro válido. O número de ações regulatórias relacionadas a aspectos de segurança em nosso país foi inferior ao de países com SRA. É necessário fortalecer o sistema de farmacovigilância e que a ANMAT aplique medidas que reduzam o risco associado ao uso dos medicamentos questionados. Universidad Nacional Córdoba. Facultad de Ciencias Médicas. Secretaria de Ciencia y Tecnología 2025-06-26 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion text/html application/pdf https://revistas.unc.edu.ar/index.php/med/article/view/46049 10.31053/1853.0605.v82.n2.46049 Revista de la Facultad de Ciencias Médicas de Córdoba.; ##issue.vol## 82 ##issue.no## 2 (2025); 253-270 Revista de la Facultad de Ciencias Médicas de Córdoba; Vol. 82 Núm. 2 (2025); 253-270 Revista da Faculdade de Ciências Médicas de Córdoba; v. 82 n. 2 (2025); 253-270 1853-0605 0014-6722 10.31053/1853.0605.v82.n2 spa https://revistas.unc.edu.ar/index.php/med/article/view/46049/49096 https://revistas.unc.edu.ar/index.php/med/article/view/46049/49097 Derechos de autor 2025 Universidad Nacional de Córdoba https://creativecommons.org/licenses/by-nc/4.0 |