Benefits and risks of fluoride supplements of Brazilian market

Detalhes bibliográficos
Autor(a) principal: Rebelo, Maria Augusta Bessa
Data de Publicação: 2014
Outros Autores: Fernandez-Alves, Caroline Saldanha, Bulcão, Lívea Nancy, Cury, Jaime Aparecido
Tipo de documento: Artigo
Idioma: por
Título da fonte: Vigilância Sanitária em Debate
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/206
Resumo: Since the use of any medicine should be based on evidence of its benefits and risks, the aim of this study was to evaluate the information contained in the leaflets provided with pre- and post-natal fluoride supplements found in the Brazilian market. Also, it was discussed the anticaries benefit and risk of dental fluorosis resulting from the use of these medications. The sample consisted of information leaflets of medications available on the Brazilian market, with 2 being for pre- and 6 post-natal use. The variables indication, contra-indication and dosage described in the leaflets were analyzed and compared with both the recommendations made by Brazilian and International institutions on the use of these medications, and with the present knowledge about how fluoride controls caries. It was found that there was incoherence between the indications and contra-indications in the information leaflets and the recommendations of institutions as regards these medications. Furthermore, the information was not consistent with present scientific knowledge about the benefits and risks of these medications. In addition, all the medications are formulated with a mixture of calcium salts and fluoride, suggesting that even if the use of these medications were important for control of caries, the fluoride present would not be bioavailable to exert its effect. It was concluded that it is necessary to perform a complete revision of Brazilian standardization of the pre- and post-natal use of fluoride supplements, in view of the inconsistencies found in the information leaflets of products for sale, whether in terms of their possible anticaries effect or risk of dental fluorosis.
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spelling Benefits and risks of fluoride supplements of Brazilian marketBenefícios e riscos dos suplementos medicamentosos fluoretados do mercado brasileiroPre-Natal FluoridePost-Natal FluorideDental CariesDental FluorosisFluoride SupplementsFlúor Pré-NatalFlúor Pós-NatalCárie DentáriaFluorose DentáriaSince the use of any medicine should be based on evidence of its benefits and risks, the aim of this study was to evaluate the information contained in the leaflets provided with pre- and post-natal fluoride supplements found in the Brazilian market. Also, it was discussed the anticaries benefit and risk of dental fluorosis resulting from the use of these medications. The sample consisted of information leaflets of medications available on the Brazilian market, with 2 being for pre- and 6 post-natal use. The variables indication, contra-indication and dosage described in the leaflets were analyzed and compared with both the recommendations made by Brazilian and International institutions on the use of these medications, and with the present knowledge about how fluoride controls caries. It was found that there was incoherence between the indications and contra-indications in the information leaflets and the recommendations of institutions as regards these medications. Furthermore, the information was not consistent with present scientific knowledge about the benefits and risks of these medications. In addition, all the medications are formulated with a mixture of calcium salts and fluoride, suggesting that even if the use of these medications were important for control of caries, the fluoride present would not be bioavailable to exert its effect. It was concluded that it is necessary to perform a complete revision of Brazilian standardization of the pre- and post-natal use of fluoride supplements, in view of the inconsistencies found in the information leaflets of products for sale, whether in terms of their possible anticaries effect or risk of dental fluorosis.Considerando que o uso de qualquer medicamento deveria estar fundamentado nas evidências sobre seus benefícios e riscos, o objetivo deste estudo foi avaliar as informações contidas nas bulas dos suplementos medicamentosos fluoretados pré- e pós-natal do mercado brasileiro e discutir o benefício anticárie e risco de fluorose dentária decorrente do uso desses produtos. A amostra foi constituída por bulas dos medicamentos disponíveis no mercado brasileiro, sendo 2 pré- e 6 pós-natal. As variáveis “indicação, contraindicação e posologia” descritas nas bulas foram analisadas e confrontadas tanto com as recomendações feitas por instituições brasileiras e internacionais do uso desses medicamentos quanto com o conhecimento atual de como o fluoreto controla cárie. Foi constatado haver incoerência entre as indicações e contraindicações contidas nas bulas e as recomendações institucionais desses medicamentos. As informações também não condizem com o conhecimento científico atual sobre os benefícios e riscos desses medicamentos. Em acréscimo, todos os medicamentos são formulados com uma mistura de sais de cálcio e de fluoreto, sugerindo que, mesmo que o uso desses medicamentos fosse importante para o controle de cárie, o fluoreto presente não estaria biodisponível para exercer seu efeito. Conclui-se que é necessário fazer uma revisão total da normatização brasileira sobre o uso de suplementos medicamentosos fluoretados pré- e pós-natal, tendo em vista as inconsistências encontradas nas bulas dos produtos à venda, quer em termos de possível efeito anticárie ou de risco de fluorose dentária.Instituto Nacional de Controle de Qualidade em Saúde2014-08-28info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/20610.3395/vd.v2n3.206Health Surveillance under Debate: Society, Science & Technology ; Vol. 2 No. 3 (2014): August; 80-85Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 2 Núm. 3 (2014): Agosto; 80-85Vigil Sanit Debate, Rio de Janeiro; v. 2 n. 3 (2014): Agosto; 80-852317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/206/139Copyright (c) 2014 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessRebelo, Maria Augusta BessaFernandez-Alves, Caroline SaldanhaBulcão, Lívea NancyCury, Jaime Aparecido2023-06-27T14:57:33Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/206Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T14:57:33Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Benefits and risks of fluoride supplements of Brazilian market
Benefícios e riscos dos suplementos medicamentosos fluoretados do mercado brasileiro
title Benefits and risks of fluoride supplements of Brazilian market
spellingShingle Benefits and risks of fluoride supplements of Brazilian market
Rebelo, Maria Augusta Bessa
Pre-Natal Fluoride
Post-Natal Fluoride
Dental Caries
Dental Fluorosis
Fluoride Supplements
Flúor Pré-Natal
Flúor Pós-Natal
Cárie Dentária
Fluorose Dentária
title_short Benefits and risks of fluoride supplements of Brazilian market
title_full Benefits and risks of fluoride supplements of Brazilian market
title_fullStr Benefits and risks of fluoride supplements of Brazilian market
title_full_unstemmed Benefits and risks of fluoride supplements of Brazilian market
title_sort Benefits and risks of fluoride supplements of Brazilian market
author Rebelo, Maria Augusta Bessa
author_facet Rebelo, Maria Augusta Bessa
Fernandez-Alves, Caroline Saldanha
Bulcão, Lívea Nancy
Cury, Jaime Aparecido
author_role author
author2 Fernandez-Alves, Caroline Saldanha
Bulcão, Lívea Nancy
Cury, Jaime Aparecido
author2_role author
author
author
dc.contributor.author.fl_str_mv Rebelo, Maria Augusta Bessa
Fernandez-Alves, Caroline Saldanha
Bulcão, Lívea Nancy
Cury, Jaime Aparecido
dc.subject.por.fl_str_mv Pre-Natal Fluoride
Post-Natal Fluoride
Dental Caries
Dental Fluorosis
Fluoride Supplements
Flúor Pré-Natal
Flúor Pós-Natal
Cárie Dentária
Fluorose Dentária
topic Pre-Natal Fluoride
Post-Natal Fluoride
Dental Caries
Dental Fluorosis
Fluoride Supplements
Flúor Pré-Natal
Flúor Pós-Natal
Cárie Dentária
Fluorose Dentária
description Since the use of any medicine should be based on evidence of its benefits and risks, the aim of this study was to evaluate the information contained in the leaflets provided with pre- and post-natal fluoride supplements found in the Brazilian market. Also, it was discussed the anticaries benefit and risk of dental fluorosis resulting from the use of these medications. The sample consisted of information leaflets of medications available on the Brazilian market, with 2 being for pre- and 6 post-natal use. The variables indication, contra-indication and dosage described in the leaflets were analyzed and compared with both the recommendations made by Brazilian and International institutions on the use of these medications, and with the present knowledge about how fluoride controls caries. It was found that there was incoherence between the indications and contra-indications in the information leaflets and the recommendations of institutions as regards these medications. Furthermore, the information was not consistent with present scientific knowledge about the benefits and risks of these medications. In addition, all the medications are formulated with a mixture of calcium salts and fluoride, suggesting that even if the use of these medications were important for control of caries, the fluoride present would not be bioavailable to exert its effect. It was concluded that it is necessary to perform a complete revision of Brazilian standardization of the pre- and post-natal use of fluoride supplements, in view of the inconsistencies found in the information leaflets of products for sale, whether in terms of their possible anticaries effect or risk of dental fluorosis.
publishDate 2014
dc.date.none.fl_str_mv 2014-08-28
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/206
10.3395/vd.v2n3.206
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/206
identifier_str_mv 10.3395/vd.v2n3.206
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/206/139
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
dc.source.none.fl_str_mv Health Surveillance under Debate: Society, Science & Technology ; Vol. 2 No. 3 (2014): August; 80-85
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 2 Núm. 3 (2014): Agosto; 80-85
Vigil Sanit Debate, Rio de Janeiro; v. 2 n. 3 (2014): Agosto; 80-85
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
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institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
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repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
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