[因安全问题在其他国家撤回的药品：它们是否应继续在阿根廷药品市场上供应？]
[Medicines withdrawn in other countries due to safety concerns: should they continue to be available in the Argentine pharmaceutical market?].
作者信息
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
机构信息
Centro Universitario de Farmacología (CUFAR). Facultad de Ciencias Médicas. Universidad Nacional de La Plata. Argentina. Centro colaborador de OMS/OPS.
CUFAR. Centro Universitario de Farmacología. Facultad de Ciencias Médicas. UNLP.
出版信息
Rev Fac Cien Med Univ Nac Cordoba. 2022 Sep 16;79(3):241-247. doi: 10.31053/1853.0605.v79.n3.35443.
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Numerous medicines have been withdrawn from the market because of the risks of serious adverse effects. The objective of this study was to identify in the Argentine pharmaceutical market (APM) the presence of medicines withdrawn in other countries due to safety problems, to analyze the information on their risks and to propose recommendations.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observational, descriptive study that explored the presence in the APM, until May 2021, of 462 medicines withdrawn in other countries.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.
引言
众多药物因存在严重不良反应风险而被撤出市场。本研究的目的是在阿根廷药品市场（APM）中识别出因安全问题在其他国家已被撤出的药物，分析其风险信息并提出建议。
方法
一项观察性描述性研究，探究截至2021年5月在APM中存在的462种在其他国家已被撤出的药物。对该清单上存在于APM且在卫生监管严格的国家当前未获批准的药物进行研究。
结果
17种药物仍存在于APM中，其中一种为非处方药。17种药物中有11种的药品说明书未提及导致其被撤出的不良反应。认为其中16种药物在APM中的留存情况应重新评估。
结论
针对监管当局对APM中已存在的这17种药物应采取的行动提出了建议。
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