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
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/41579

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oai_identifier_str oai:ri.conicet.gov.ar:11336/41579
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repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling 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
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
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dc.publisher.none.fl_str_mv Pergamon-Elsevier Science Ltd
publisher.none.fl_str_mv Pergamon-Elsevier Science Ltd
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
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instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
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repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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