{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T07:47:16Z","timestamp":1791359236034,"version":"4.3.1"},"reference-count":25,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2019,7,10]],"date-time":"2019-07-10T00:00:00Z","timestamp":1562716800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100002322","name":"Coordena\u00e7\u00e3o de Aperfei\u00e7oamento de Pessoal de N\u00edvel Superior-Brazil","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002322","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Brazilian National Council for Scientific and Technological Development-CNPq-Brazil","award":["405145\/2018-7"],"award-info":[{"award-number":["405145\/2018-7"]}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Evaluation Clinical Practice"],"published-print":{"date-parts":[[2020,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Rationale, aims, and objectives<\/jats:title><jats:p>As a pharmacovigilance measure, the Brazilian Health Regulatory Agency (ANVISA) monitors the postmarketing events of medication and issues alerts on actions to be taken and information updates. The present study has the objective of analysing the profile of all the alerts on medication issued by ANVISA between 2006 and 2018.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A descriptive documentary analysis was carried out through the ANVISA website and double checked with two researchers in order to avoid discrepancies in data collection and interpretation of information.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 79 alerts available in the period were analysed, the mean being 6.07 alerts\/year and standard deviation of 3.81. The medications most cited in the alerts were antivirals (9.7%), followed by antidiabetics (7.3%) and contraceptives (7.3%). The main problems identified were adverse reactions (50%) and other problems related to safety (15%). The main actions directed by ANVISA were generation of a new contraindication (37.3%) and alteration in the package insert (22.3%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Alerts are an important means of communicating new information to health professionals and to society. However, they need better standardization in order to facilitate understanding, dissemination in order to broaden access to information, and studies to corroborate the current literature and improve current pharmacovigilance.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jep.13233","type":"journal-article","created":{"date-parts":[[2019,7,10]],"date-time":"2019-07-10T11:27:02Z","timestamp":1562758022000},"page":"957-961","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Thirteen years of medication alerts issued by the Brazilian Health Regulatory Agency (ANVISA): What is the profile?"],"prefix":"10.1111","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0681-6599","authenticated-orcid":false,"given":"Vitor Costa","family":"Ferreira","sequence":"first","affiliation":[{"name":"Campus Centro\u2010Oeste Dona Lindu (CCO) Federal University of S\u00e3o Jo\u00e3o Del\u2010Rei (UFSJ)  Divin\u00f3polis Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gustavo Costa","family":"Ferreira","sequence":"additional","affiliation":[{"name":"Campus Centro\u2010Oeste Dona Lindu (CCO) Federal University of S\u00e3o Jo\u00e3o Del\u2010Rei (UFSJ)  Divin\u00f3polis Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andr\u00e9 Oliveira","family":"Baldoni","sequence":"additional","affiliation":[{"name":"Campus Centro\u2010Oeste Dona Lindu (CCO) Federal University of S\u00e3o Jo\u00e3o Del\u2010Rei (UFSJ)  Divin\u00f3polis Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,7,10]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1590\/S1516-93322006000400002"},{"key":"e_1_2_7_3_1","unstructured":"Ferreira MS.Medicaliza\u00e7\u00e3o da vida. 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