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Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study.
J Clin Pharmacol. 2017 04; 57(4):493-499.JC

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+Show Affiliations

Universidade Federal de Minas Gerais Hospital Risoleta Tolentino Neves, R. das Gabirobas, Belo Horizonte, Brazil.Universidade Federal de Minas Gerais, Faculdade de Farmácia, Av Antônio Carlos 6627 Pampulha, Belo Horizonte, Brazil.Universidade Federal de Juiz de Fora, Departamento de Farmácia, Campus Governador Valadares, Universitário 35020220, Governador Valadares, Brazil.Universidade Federal de Minas Gerais, Faculdade de Farmácia, Av Antônio Carlos 6627 Pampulha, Belo Horizonte, Brazil.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27568487

Citation

Botelho, Stephanie Ferreira, et al. "Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: a Retrospective Cohort Study." Journal of Clinical Pharmacology, vol. 57, no. 4, 2017, pp. 493-499.
Botelho SF, Martins MA, Vieira LB, et al. Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study. J Clin Pharmacol. 2017;57(4):493-499.
Botelho, S. F., Martins, M. A., Vieira, L. B., & Reis, A. M. (2017). Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study. Journal of Clinical Pharmacology, 57(4), 493-499. https://doi.org/10.1002/jcph.822
Botelho SF, et al. Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: a Retrospective Cohort Study. J Clin Pharmacol. 2017;57(4):493-499. PubMed PMID: 27568487.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study. AU - Botelho,Stephanie Ferreira, AU - Martins,Maria Auxiliadora Parreiras, AU - Vieira,Liliana Batista, AU - Reis,Adriano Max Moreira, Y1 - 2016/09/30/ PY - 2016/07/14/received PY - 2016/08/25/accepted PY - 2016/8/30/pubmed PY - 2017/8/16/medline PY - 2016/8/30/entrez KW - drug approval KW - drug safety KW - new drugs KW - pharmacovigilance KW - safety alert SP - 493 EP - 499 JF - Journal of clinical pharmacology JO - J Clin Pharmacol VL - 57 IS - 4 N2 - 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. SN - 1552-4604 UR - https://www.unboundmedicine.com/medline/citation/27568487/Postmarketing_Safety_Events_Relating_to_New_Drugs_Approved_in_Brazil_Between_2003_and_2013:_A_Retrospective_Cohort_Study_ L2 - https://doi.org/10.1002/jcph.822 DB - PRIME DP - Unbound Medicine ER -