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Medicamentos retirados en otros países por problemas de seguridad: ¿Deben seguir presentes en el mercado farmacéutico argentino?

INTRODUCTION: Numerous medicines have been withdrawn from the market because of the risks of serious adverse effects. The objective of this study was to identify in the Argentine pharmaceutical market (APM) the presence of medicines withdrawn in other countries due to safety problems, to analyze the...

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Detalles Bibliográficos
Autores principales: Buschiazzo, Héctor O, Dorati, Cristian M, Venturini, Nasim Iusef, Cañás, Martín, Urtasun, Martín Alejandro, Marin, Gustavo H, Prozzi, Guillermo Rafael, Rivadulla, Patricia Alejandra, Trionfetti, Mariángeles, Mordujovich-Buschiazzo1, Perla
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Universidad Nacional de Córdoba 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9590832/
https://www.ncbi.nlm.nih.gov/pubmed/36149072
http://dx.doi.org/10.31053/1853.0605.v79.n3.35443
Descripción
Sumario:INTRODUCTION: Numerous medicines have been withdrawn from the market because of the risks of serious adverse effects. The objective of this study was to identify in the Argentine pharmaceutical market (APM) the presence of medicines withdrawn in other countries due to safety problems, to analyze the information on their risks and to propose recommendations. METHOD: observational, descriptive study that explored the presence in the APM, until May 2021, of 462 medicines withdrawn in other countries. Those medicines on this list that are present in the APM and that are not currently authorized in countries with high sanitary surveillance were studied. RESULTS: 17 medicines are still present in the APM, one over-the-counter. The package insert for 11 of the 17 medicines does not mention the adverse effects that led to their withdrawal. It was considered that the permanence in the APM of 16 of them should be reassessed. CONCLUSIONS: recommendations are made on actions to be taken by the regulatory authorities with the 17 medicines already present in the APM.