Revista de la Facultad de Ciencias Medicas (Cordoba, Argentina) · 2022
[Medicines withdrawn in other countries due to safety concerns: should they continue to be available in the Argentine pharmaceutical market?].
СтатьяНазвание и аннотация: Перевод в очереди
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Buschiazzo Héctor, Dorati Cristian, Iusef Venturini Nasim, Cañas Martín, Urtasun Martín Alejandro, Marin Gustavo H, Prozzi Guillermo Rafael, Rivadulla Patricia Alejandra, Trionfetti Mariángeles, Mordujovich Buschiazzo Perla
Аннотация
INTRODUCTION: Numerous medicines have been withdrawn from the market because of the risks of serious adverse effects. The objective of this study was to identify in the Argentine pharmaceutical market (APM) the presence of medicines withdrawn in other countries due to safety problems, to analyze the information on their risks and to propose recommendations.
METHOD: observational, descriptive study that explored the presence in the APM, until May 2021, of 462 medicines withdrawn in other countries.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.
METHOD: observational, descriptive study that explored the presence in the APM, until May 2021, of 462 medicines withdrawn in other countries.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.