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| Format: | Artículo científico |
| Language: | en |
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Fundação Oswaldo Cruz
2021
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| Online Access: | https://www.redalyc.org/articulo.oa?id=570569642003 https://www.redalyc.org/journal/5705/570569642003/ https://www.redalyc.org/journal/5705/570569642003/html/ https://www.redalyc.org/journal/5705/570569642003/570569642003.epub https://www.redalyc.org/journal/5705/570569642003/movil |
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| _version_ | 1866580121605898240 |
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| author | Lisiane Freitas Leal |
| author_facet | Lisiane Freitas Leal |
| contents | Thalidomide surveillance and pharmacovigilance in Brazil – an overview Lisiane Freitas Leal Daniel Marques Mota Multidisciplinaria (Ciencias Naturales y Exactas) Thalidomide Postmarketing Fetal Diseases Pharmacovigilance Product Surveillance Introduction The thalidomide is probably the best-known teratogenic drug and still results in cases of severe physical deformities in children born in Brazil.Objective To present the overall context of surveillance and pharmacovigilance of thalidomide in Brazil.Method This article presents a narrative review of current literature concerning thalidomide regulation, policies, and pharmacovigilance in Brazil.Results New cases of congenital abnormalities whose phenotype is compatible with thalidomide embryopathy were identified in the last ten years, while the approval of thalidomide for new indications was recently updated. The mechanisms of diagnosing thalidomide embryopathy are complex, remaining the challenge in distinguishing this condition from other congenital abnormalities. The increasing number of thalidomide users in Brazil is correlated with the occurrence of embryopathy and the real extension of the rationality of its use is largely unknown. Additionally, our pharmacovigilance and surveillance systems are predominantly based on voluntary reports, issues that remains over the years.Conclusions The policies have improved over the years to prevent the fetus from being exposed to thalidomide, and current regulation establishes rules for controlling its distribution, prescription, dispensation, and use. Brazilian surveillance system is manual and pharmacovigilance is supported by voluntary reports. The failure of the system to properly control the thalidomide use and its effects might lead to serious consequences to the community; therefore, this subject deserves constant attention. 2021 artículo científico 2317-269X https://www.redalyc.org/articulo.oa?id=570569642003 https://www.redalyc.org/journal/5705/570569642003/ https://www.redalyc.org/journal/5705/570569642003/html/ https://www.redalyc.org/journal/5705/570569642003/570569642003.epub https://www.redalyc.org/journal/5705/570569642003/movil 10.22239/2317-269X.01557 en http://www.redalyc.org/revista.oa?id=5705 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia application/pdf Fundação Oswaldo Cruz Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Brasil) Num.2 Vol.9 |
| format | Artículo científico |
| id | redalyc_570569642003 |
| language | en |
| publishDate | 2021 |
| publisher | Fundação Oswaldo Cruz |
| spellingShingle | Thalidomide surveillance and pharmacovigilance in Brazil – an overview Lisiane Freitas Leal Multidisciplinaria (Ciencias Naturales y Exactas) Thalidomide Postmarketing Fetal Diseases Pharmacovigilance Product Surveillance Thalidomide surveillance and pharmacovigilance in Brazil – an overview Lisiane Freitas Leal Daniel Marques Mota Multidisciplinaria (Ciencias Naturales y Exactas) Thalidomide Postmarketing Fetal Diseases Pharmacovigilance Product Surveillance Introduction The thalidomide is probably the best-known teratogenic drug and still results in cases of severe physical deformities in children born in Brazil.Objective To present the overall context of surveillance and pharmacovigilance of thalidomide in Brazil.Method This article presents a narrative review of current literature concerning thalidomide regulation, policies, and pharmacovigilance in Brazil.Results New cases of congenital abnormalities whose phenotype is compatible with thalidomide embryopathy were identified in the last ten years, while the approval of thalidomide for new indications was recently updated. The mechanisms of diagnosing thalidomide embryopathy are complex, remaining the challenge in distinguishing this condition from other congenital abnormalities. The increasing number of thalidomide users in Brazil is correlated with the occurrence of embryopathy and the real extension of the rationality of its use is largely unknown. Additionally, our pharmacovigilance and surveillance systems are predominantly based on voluntary reports, issues that remains over the years.Conclusions The policies have improved over the years to prevent the fetus from being exposed to thalidomide, and current regulation establishes rules for controlling its distribution, prescription, dispensation, and use. Brazilian surveillance system is manual and pharmacovigilance is supported by voluntary reports. The failure of the system to properly control the thalidomide use and its effects might lead to serious consequences to the community; therefore, this subject deserves constant attention. 2021 artículo científico 2317-269X https://www.redalyc.org/articulo.oa?id=570569642003 https://www.redalyc.org/journal/5705/570569642003/ https://www.redalyc.org/journal/5705/570569642003/html/ https://www.redalyc.org/journal/5705/570569642003/570569642003.epub https://www.redalyc.org/journal/5705/570569642003/movil 10.22239/2317-269X.01557 en http://www.redalyc.org/revista.oa?id=5705 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia application/pdf Fundação Oswaldo Cruz Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Brasil) Num.2 Vol.9 |
| title | Thalidomide surveillance and pharmacovigilance in Brazil – an overview |
| topic | Multidisciplinaria (Ciencias Naturales y Exactas) Thalidomide Postmarketing Fetal Diseases Pharmacovigilance Product Surveillance |
| url | https://www.redalyc.org/articulo.oa?id=570569642003 https://www.redalyc.org/journal/5705/570569642003/ https://www.redalyc.org/journal/5705/570569642003/html/ https://www.redalyc.org/journal/5705/570569642003/570569642003.epub https://www.redalyc.org/journal/5705/570569642003/movil |