[Medicines withdrawn in other countries due to safety problems, between 2014 and 2023, and their permanence in the Argentine market].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 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Identify medicines that have been withdrawn from marketing for safety reasons in countries with health reference agencies (SRA), between January 2014 and June 2023. Establish if these medicines were withdrawn from the market in Argentina.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 For each medication withdrawn by any SRA, the validity of the marketing certificate and regulatory actions in Argentina were verified.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In countries with SRA health agencies, 31 medications were withdrawn for safety reasons. Of these, in Argentina, 7 were identified with a valid marketing certificate, another 7 were withdrawn from the market mostly by the manufacturing laboratories, 14 were never marketed and no data was obtained for 3.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In Argentina, medications were identified that were withdrawn from other countries and continue to have a valid marketing certificate.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.