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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\u2010Meier 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.<\/jats:p>","DOI":"10.1002\/jcph.822","type":"journal-article","created":{"date-parts":[[2016,8,29]],"date-time":"2016-08-29T09:02:41Z","timestamp":1472461361000},"page":"493-499","source":"Crossref","is-referenced-by-count":4,"title":["Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study"],"prefix":"10.1002","volume":"57","author":[{"given":"Stephanie Ferreira","family":"Botelho","sequence":"first","affiliation":[{"name":"Universidade Federal de Minas Gerais Hospital Risoleta Tolentino Neves R. das Gabirobas  Belo Horizonte Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Auxiliadora Parreiras","family":"Martins","sequence":"additional","affiliation":[{"name":"Universidade Federal de Minas Gerais Faculdade de Farm\u00e1cia  Av Ant\u00f4nio Carlos 6627 Pampulha, Belo Horizonte Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liliana Batista","family":"Vieira","sequence":"additional","affiliation":[{"name":"Universidade Federal de Juiz de Fora Departamento de Farm\u00e1cia Campus Governador Valadares  Universit\u00e1rio 35020220, Governador Valadares Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adriano Max Moreira","family":"Reis","sequence":"additional","affiliation":[{"name":"Universidade Federal de Minas Gerais Faculdade de Farm\u00e1cia  Av Ant\u00f4nio Carlos 6627 Pampulha, Belo Horizonte Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,9,30]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.2165\/11532840-000000000-00000"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2011.03995.x"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0094-y"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2012.262"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-pharmtox-011613-135955"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-014-1670-5"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2014.184"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0126-7"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.300.16.1887"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2013-004289"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12552"},{"key":"e_1_2_8_13_1","volume-title":"Drug Approval Reports","author":"Food and Drug Administration"},{"key":"e_1_2_8_14_1","first-page":"337","article-title":"To market, to market\u20142003","volume":"39","author":"Hegde S","year":"2004","journal-title":"Annu Rep Med Chem"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0065-7743(05)40029-9"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0065-7743(06)41030-7"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0065-7743(07)42032-2"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0065-7743(08)00025-0"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0065-7743(09)04428-5"},{"key":"e_1_2_8_20_1","first-page":"467","article-title":"To market, to market\u20142009","volume":"45","author":"Hegde S","year":"2010","journal-title":"Annu Rep Med Chem"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-386009-5.00002-3"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-396492-2.00031-X"},{"key":"e_1_2_8_23_1","first-page":"472","article-title":"To market, to market\u20142012","volume":"48","author":"Hegde S","year":"2013","journal-title":"Annu Rep Med Chem"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-800167-7.00027-4"},{"key":"e_1_2_8_25_1","unstructured":"Imprensa Nacional.Portal da imprensa nacional.http:\/\/portal.in.gov.br\/. 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