title: Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study.
abstract: This study investigated postmarketing safety events (PMSEs) for new drugs approved in Brazil and evaluated whether a range of drug characteristics influenced the time between approval and the first PMSE. This retrospective study included new drugs registered between 2003 and 2013 by the National Health Surveillance Agency (ANVISA), which is responsible for medicines approval in Brazil. PMSEs were defined as any drug safety alert or drug withdrawal from the market. The existence of risk evaluation and mitigation strategies (REMS) by the US Food and Drug Administration (FDA) and Brazil were recorded. A Kaplan-Meier survival curve of the period between the date of ANVISA registration and the PMSE was calculated. We found a statistically significant difference between the time to PMSE for drugs with an FDA REMS compared with those without a REMS, with a log rank value (Mantel Cox) of 0.002. There was no association between the time to PMSE and the other drug characteristics investigated. This study demonstrated that the frequency of PMSEs for new drugs approved by ANVISA was statistically associated with the existence of an FDA REMS. The time between approval and first PMSE was shorter for drugs with an FDA REMS, and this finding may contribute to improved awareness of the risk/benefit balance required to ensure continued safe and effective use of new drugs.
authors: Universidade Federal de Minas Gerais Hospital Risoleta Tolentino Neves, R. das Gabirobas, Belo Horizonte, Brazil.
authors: Stephanie Ferreira
authors: SF
authors: Botelho
authors: Universidade Federal de Minas Gerais, Faculdade de Farmácia, Av Antônio Carlos 6627 Pampulha, Belo Horizonte, Brazil.
authors: Maria Auxiliadora Parreiras
authors: MA
authors: Martins
authors: Universidade Federal de Juiz de Fora, Departamento de Farmácia, Campus Governador Valadares, Universitário 35020220, Governador Valadares, Brazil.
authors: Liliana Batista
authors: LB
authors: Vieira
authors: Universidade Federal de Minas Gerais, Faculdade de Farmácia, Av Antônio Carlos 6627 Pampulha, Belo Horizonte, Brazil.
authors: Adriano Max Moreira
authors: AM
authors: Reis
mesh_terms: D001938:Brazil; D016208:Databases, Factual / Q000639:trends; D017277:Drug Approval / Q000379:methods*; D004348:Drug Labeling / Q000379:methods* / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000639:trends*; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration / Q000639:trends*
keywords: drug approval; drug safety; new drugs; pharmacovigilance; safety alert