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

Abstract

Introduction: Numerous medicines have been withdrawn from the market because of therisks of serious adverse effects. The objective of this study was to identify in the Argentinepharmaceutical market (APM) the presence of medicines withdrawn in other countries dueto safety problems, to analyze the information on their risks and to proposerecommendations. Method: observational, descriptive study that explored the presence inthe APM, until May 2021, of 462 medicines withdrawn in other countries. Those medicineson this list that are present in the APM and that are not currently authorized in countrieswith high sanitary surveillance were studied. Results: 17 medicines are still present in theAPM, one over-the-counter. The package insert for 11 of the 17 medicines does notmention the adverse effects that led to their withdrawal. It was considered that thepermanence in the APM of 16 of them should be reassessed. Conclusions:recommendations are made on actions to be taken by the regulatory authorities with the17 medicines already present in the APM.