Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil
- Autores
- Vianna, Fernanda Sales Luiz; Oliveira, Marcelo Zagonel de; Sanseverino, Maria Teresa Vieira; Morelo, Elaine Faria; Rabello Neto, Dacio de Lyra; López Camelo, Jorge Santiago; Camey, Suzi Alves; Schuler Faccini, Lavinia
- Año de publicación
- 2015
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- Introduction: Thalidomide causes congenital defects in children, such as limb reduction defects. Currently, it is used for a few indications; in Brazil, where leprosy is endemic, thalidomide is used for the treatment of erythema nodosum leprosum, and recent cases of thalidomide embryopathy have been reported. Methods: We analyzed the frequency of births with phenotypes consistent with thalidomide embryopathy (TEP) and correlated this with the distribution of thalidomide and the prevalence of leprosy between 2005 and 2010 in Brazil. Results: A total of 5,889,210 thalidomide tablets were distributed; the prevalence of limb reduction defects was 1.60 (CI95%: 1.54–1.66) and TEP was 0.11 (CI95%: 0.10–0.13) per 10,000 births. Poisson regression showed an increase in cases of TEP and limb reduction defects per 100,000 tablets dispensed. Clusters and geographical isolates were identified in several regions. Conclusions: There is a correlation between thalidomide and TEP showing that thalidomide embryopathy should be monitored in countries where this medication is available.
Fil: Vianna, Fernanda Sales Luiz. Instituto Nacional de Genética Médica Populacional; Brasil. Hospital de Clínicas de Porto Alegre; Brasil. Universidade Federal do Rio Grande do Sul; Brasil
Fil: Oliveira, Marcelo Zagonel de. Instituto Nacional de Genética Médica Populacional; Brasil. Universidade Federal do Rio Grande do Sul; Brasil
Fil: Sanseverino, Maria Teresa Vieira. Instituto Nacional de Genética Médica Populacional; Brasil. Hospital de Clínicas de Porto Alegre; Brasil
Fil: Morelo, Elaine Faria. Programa Nacional da Hanseníase; Brasil
Fil: Rabello Neto, Dacio de Lyra. Ministério da Saúde do Brasilia; Brasil
Fil: López Camelo, Jorge Santiago. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata. Instituto Multidisciplinario de Biología Celular. Provincia de Buenos Aires. Gobernación. Comisión de Investigaciones Científicas. Instituto Multidisciplinario de Biología Celular. Universidad Nacional de La Plata. Instituto Multidisciplinario de Biología Celular; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina
Fil: Camey, Suzi Alves. Universidade Federal do Rio Grande do Sul; Brasil
Fil: Schuler Faccini, Lavinia. Hospital de Clínicas de Porto Alegre; Brasil. Instituto Nacional de Genética Médica Populacional; Brasil. Universidade Federal do Rio Grande do Sul; Brasil - Materia
-
Pharmacoepidemology
Embryopathy
Surveillance - Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
- Repositorio
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/41579
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Pharmacoepidemiology and thalidomide embryopathy surveillance in BrazilVianna, Fernanda Sales LuizOliveira, Marcelo Zagonel deSanseverino, Maria Teresa VieiraMorelo, Elaine FariaRabello Neto, Dacio de LyraLópez Camelo, Jorge SantiagoCamey, Suzi AlvesSchuler Faccini, LaviniaPharmacoepidemologyEmbryopathySurveillancehttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Introduction: Thalidomide causes congenital defects in children, such as limb reduction defects. Currently, it is used for a few indications; in Brazil, where leprosy is endemic, thalidomide is used for the treatment of erythema nodosum leprosum, and recent cases of thalidomide embryopathy have been reported. Methods: We analyzed the frequency of births with phenotypes consistent with thalidomide embryopathy (TEP) and correlated this with the distribution of thalidomide and the prevalence of leprosy between 2005 and 2010 in Brazil. Results: A total of 5,889,210 thalidomide tablets were distributed; the prevalence of limb reduction defects was 1.60 (CI95%: 1.54–1.66) and TEP was 0.11 (CI95%: 0.10–0.13) per 10,000 births. Poisson regression showed an increase in cases of TEP and limb reduction defects per 100,000 tablets dispensed. Clusters and geographical isolates were identified in several regions. Conclusions: There is a correlation between thalidomide and TEP showing that thalidomide embryopathy should be monitored in countries where this medication is available.Fil: Vianna, Fernanda Sales Luiz. Instituto Nacional de Genética Médica Populacional; Brasil. Hospital de Clínicas de Porto Alegre; Brasil. Universidade Federal do Rio Grande do Sul; BrasilFil: Oliveira, Marcelo Zagonel de. Instituto Nacional de Genética Médica Populacional; Brasil. Universidade Federal do Rio Grande do Sul; BrasilFil: Sanseverino, Maria Teresa Vieira. Instituto Nacional de Genética Médica Populacional; Brasil. Hospital de Clínicas de Porto Alegre; BrasilFil: Morelo, Elaine Faria. Programa Nacional da Hanseníase; BrasilFil: Rabello Neto, Dacio de Lyra. Ministério da Saúde do Brasilia; BrasilFil: López Camelo, Jorge Santiago. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata. Instituto Multidisciplinario de Biología Celular. Provincia de Buenos Aires. Gobernación. Comisión de Investigaciones Científicas. Instituto Multidisciplinario de Biología Celular. Universidad Nacional de La Plata. Instituto Multidisciplinario de Biología Celular; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; ArgentinaFil: Camey, Suzi Alves. Universidade Federal do Rio Grande do Sul; BrasilFil: Schuler Faccini, Lavinia. Hospital de Clínicas de Porto Alegre; Brasil. Instituto Nacional de Genética Médica Populacional; Brasil. Universidade Federal do Rio Grande do Sul; BrasilPergamon-Elsevier Science Ltd2015-06info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/vnd.openxmlformats-officedocument.wordprocessingml.documentapplication/pdfhttp://hdl.handle.net/11336/41579Vianna, Fernanda Sales Luiz; Oliveira, Marcelo Zagonel de; Sanseverino, Maria Teresa Vieira; Morelo, Elaine Faria; Rabello Neto, Dacio de Lyra; et al.; Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil; Pergamon-Elsevier Science Ltd; Reproductive Toxicology; 53; 6-2015; 63-670890-6238CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.reprotox.2015.03.007info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S0890623815000416info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:32:59Zoai:ri.conicet.gov.ar:11336/41579instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 09:32:59.862CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse |
dc.title.none.fl_str_mv |
Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil |
title |
Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil |
spellingShingle |
Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil Vianna, Fernanda Sales Luiz Pharmacoepidemology Embryopathy Surveillance |
title_short |
Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil |
title_full |
Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil |
title_fullStr |
Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil |
title_full_unstemmed |
Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil |
title_sort |
Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil |
dc.creator.none.fl_str_mv |
Vianna, Fernanda Sales Luiz Oliveira, Marcelo Zagonel de Sanseverino, Maria Teresa Vieira Morelo, Elaine Faria Rabello Neto, Dacio de Lyra López Camelo, Jorge Santiago Camey, Suzi Alves Schuler Faccini, Lavinia |
author |
Vianna, Fernanda Sales Luiz |
author_facet |
Vianna, Fernanda Sales Luiz Oliveira, Marcelo Zagonel de Sanseverino, Maria Teresa Vieira Morelo, Elaine Faria Rabello Neto, Dacio de Lyra López Camelo, Jorge Santiago Camey, Suzi Alves Schuler Faccini, Lavinia |
author_role |
author |
author2 |
Oliveira, Marcelo Zagonel de Sanseverino, Maria Teresa Vieira Morelo, Elaine Faria Rabello Neto, Dacio de Lyra López Camelo, Jorge Santiago Camey, Suzi Alves Schuler Faccini, Lavinia |
author2_role |
author author author author author author author |
dc.subject.none.fl_str_mv |
Pharmacoepidemology Embryopathy Surveillance |
topic |
Pharmacoepidemology Embryopathy Surveillance |
purl_subject.fl_str_mv |
https://purl.org/becyt/ford/3.3 https://purl.org/becyt/ford/3 |
dc.description.none.fl_txt_mv |
Introduction: Thalidomide causes congenital defects in children, such as limb reduction defects. Currently, it is used for a few indications; in Brazil, where leprosy is endemic, thalidomide is used for the treatment of erythema nodosum leprosum, and recent cases of thalidomide embryopathy have been reported. Methods: We analyzed the frequency of births with phenotypes consistent with thalidomide embryopathy (TEP) and correlated this with the distribution of thalidomide and the prevalence of leprosy between 2005 and 2010 in Brazil. Results: A total of 5,889,210 thalidomide tablets were distributed; the prevalence of limb reduction defects was 1.60 (CI95%: 1.54–1.66) and TEP was 0.11 (CI95%: 0.10–0.13) per 10,000 births. Poisson regression showed an increase in cases of TEP and limb reduction defects per 100,000 tablets dispensed. Clusters and geographical isolates were identified in several regions. Conclusions: There is a correlation between thalidomide and TEP showing that thalidomide embryopathy should be monitored in countries where this medication is available. Fil: Vianna, Fernanda Sales Luiz. Instituto Nacional de Genética Médica Populacional; Brasil. Hospital de Clínicas de Porto Alegre; Brasil. Universidade Federal do Rio Grande do Sul; Brasil Fil: Oliveira, Marcelo Zagonel de. Instituto Nacional de Genética Médica Populacional; Brasil. Universidade Federal do Rio Grande do Sul; Brasil Fil: Sanseverino, Maria Teresa Vieira. Instituto Nacional de Genética Médica Populacional; Brasil. Hospital de Clínicas de Porto Alegre; Brasil Fil: Morelo, Elaine Faria. Programa Nacional da Hanseníase; Brasil Fil: Rabello Neto, Dacio de Lyra. Ministério da Saúde do Brasilia; Brasil Fil: López Camelo, Jorge Santiago. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata. Instituto Multidisciplinario de Biología Celular. Provincia de Buenos Aires. Gobernación. Comisión de Investigaciones Científicas. Instituto Multidisciplinario de Biología Celular. Universidad Nacional de La Plata. Instituto Multidisciplinario de Biología Celular; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET.; Argentina Fil: Camey, Suzi Alves. Universidade Federal do Rio Grande do Sul; Brasil Fil: Schuler Faccini, Lavinia. Hospital de Clínicas de Porto Alegre; Brasil. Instituto Nacional de Genética Médica Populacional; Brasil. Universidade Federal do Rio Grande do Sul; Brasil |
description |
Introduction: Thalidomide causes congenital defects in children, such as limb reduction defects. Currently, it is used for a few indications; in Brazil, where leprosy is endemic, thalidomide is used for the treatment of erythema nodosum leprosum, and recent cases of thalidomide embryopathy have been reported. Methods: We analyzed the frequency of births with phenotypes consistent with thalidomide embryopathy (TEP) and correlated this with the distribution of thalidomide and the prevalence of leprosy between 2005 and 2010 in Brazil. Results: A total of 5,889,210 thalidomide tablets were distributed; the prevalence of limb reduction defects was 1.60 (CI95%: 1.54–1.66) and TEP was 0.11 (CI95%: 0.10–0.13) per 10,000 births. Poisson regression showed an increase in cases of TEP and limb reduction defects per 100,000 tablets dispensed. Clusters and geographical isolates were identified in several regions. Conclusions: There is a correlation between thalidomide and TEP showing that thalidomide embryopathy should be monitored in countries where this medication is available. |
publishDate |
2015 |
dc.date.none.fl_str_mv |
2015-06 |
dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo |
format |
article |
status_str |
publishedVersion |
dc.identifier.none.fl_str_mv |
http://hdl.handle.net/11336/41579 Vianna, Fernanda Sales Luiz; Oliveira, Marcelo Zagonel de; Sanseverino, Maria Teresa Vieira; Morelo, Elaine Faria; Rabello Neto, Dacio de Lyra; et al.; Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil; Pergamon-Elsevier Science Ltd; Reproductive Toxicology; 53; 6-2015; 63-67 0890-6238 CONICET Digital CONICET |
url |
http://hdl.handle.net/11336/41579 |
identifier_str_mv |
Vianna, Fernanda Sales Luiz; Oliveira, Marcelo Zagonel de; Sanseverino, Maria Teresa Vieira; Morelo, Elaine Faria; Rabello Neto, Dacio de Lyra; et al.; Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil; Pergamon-Elsevier Science Ltd; Reproductive Toxicology; 53; 6-2015; 63-67 0890-6238 CONICET Digital CONICET |
dc.language.none.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.reprotox.2015.03.007 info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S0890623815000416 |
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info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by-nc-nd/2.5/ar/ |
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openAccess |
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https://creativecommons.org/licenses/by-nc-nd/2.5/ar/ |
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application/pdf application/vnd.openxmlformats-officedocument.wordprocessingml.document application/pdf |
dc.publisher.none.fl_str_mv |
Pergamon-Elsevier Science Ltd |
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Pergamon-Elsevier Science Ltd |
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reponame:CONICET Digital (CONICET) instname:Consejo Nacional de Investigaciones Científicas y Técnicas |
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Consejo Nacional de Investigaciones Científicas y Técnicas |
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CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas |
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dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar |
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