Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10400.26/41110 https://doi.org/10.2174/1574886314666191004092520 |
Resumo: | Introduction: Several drugs were withdrawn from the market due to safety. Objective: The aim of this study was to describe data supporting drug withdrawal from the market due to safety reasons in countries belonging to the World Health Organization. Methods: We analyzed drugs withdrawn from the market between 1990 and 2010. All medicine agencies of the countries belonging to the Program for International Drug Monitoring of the World Health Organization were contacted. To complete data, Medline, reference books and available drug databases were also searched. Information sources on which authorities based their withdrawal were categorized and the average time between the first date of exposure and withdrawal was calculated and stratified. Results: A total of 133 drugs that met the inclusion/exclusion criteria were withdrawn from the market due to safety reasons in the period reviewed (1990 - 2010). Hepatotoxicity (n=36, 27.1%), cardiac disorders (n=25, 18.8%), hypersensitivity (n=17, 12.8%) and nephrotoxicity (n=14, 9.8%) were the major reasons responsible for 69.2% of all drugs withdrawn. In most cases, Information Sources for drug withdrawal were spontaneous reports and/or case reports (n=86, 64.7%), followed by clinical trials (n=24, 18.0%). The average time between the introduction of a drug and its withdrawal due to safety reasons was 20.3 years (SD±13.8). Conclusion: According to available and published evidence, there is no gold standard to identify risks associated with drug exposure. These findings strengthen the role of different information sources within the drug safety review process. |
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Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal DecisionHepatotoxicitynephrotoxicityprogram for international drug monitoringclinical trialsobservational studieslaboratory studiesIntroduction: Several drugs were withdrawn from the market due to safety. Objective: The aim of this study was to describe data supporting drug withdrawal from the market due to safety reasons in countries belonging to the World Health Organization. Methods: We analyzed drugs withdrawn from the market between 1990 and 2010. All medicine agencies of the countries belonging to the Program for International Drug Monitoring of the World Health Organization were contacted. To complete data, Medline, reference books and available drug databases were also searched. Information sources on which authorities based their withdrawal were categorized and the average time between the first date of exposure and withdrawal was calculated and stratified. Results: A total of 133 drugs that met the inclusion/exclusion criteria were withdrawn from the market due to safety reasons in the period reviewed (1990 - 2010). Hepatotoxicity (n=36, 27.1%), cardiac disorders (n=25, 18.8%), hypersensitivity (n=17, 12.8%) and nephrotoxicity (n=14, 9.8%) were the major reasons responsible for 69.2% of all drugs withdrawn. In most cases, Information Sources for drug withdrawal were spontaneous reports and/or case reports (n=86, 64.7%), followed by clinical trials (n=24, 18.0%). The average time between the introduction of a drug and its withdrawal due to safety reasons was 20.3 years (SD±13.8). Conclusion: According to available and published evidence, there is no gold standard to identify risks associated with drug exposure. These findings strengthen the role of different information sources within the drug safety review process.info:eu-repo/semantics/publishedVersionBentham Science Publishers2022-06-18T18:51:00Z2022-06-182020-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://hdl.handle.net/10400.26/41110http://hdl.handle.net/10400.26/41110https://doi.org/10.2174/1574886314666191004092520engCraveiro NS, Lopes BS, Tomás L, Almeida SF. Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision. Curr Drug Saf. 2020;15(1):4-12. doi:10.2174/15748863146661910040925201574-8863http://www.eurekaselect.com/article/101171Craveiro, Nuno SalesLopes, Bruno SilvaTomás, LaraAlmeida, Sofia Fragainfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-02-03T04:39:19Zoai:comum.rcaap.pt:10400.26/41110Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T02:07:56.344271Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision |
title |
Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision |
spellingShingle |
Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision Craveiro, Nuno Sales Hepatotoxicity nephrotoxicity program for international drug monitoring clinical trials observational studies laboratory studies |
title_short |
Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision |
title_full |
Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision |
title_fullStr |
Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision |
title_full_unstemmed |
Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision |
title_sort |
Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision |
author |
Craveiro, Nuno Sales |
author_facet |
Craveiro, Nuno Sales Lopes, Bruno Silva Tomás, Lara Almeida, Sofia Fraga |
author_role |
author |
author2 |
Lopes, Bruno Silva Tomás, Lara Almeida, Sofia Fraga |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Craveiro, Nuno Sales Lopes, Bruno Silva Tomás, Lara Almeida, Sofia Fraga |
dc.subject.por.fl_str_mv |
Hepatotoxicity nephrotoxicity program for international drug monitoring clinical trials observational studies laboratory studies |
topic |
Hepatotoxicity nephrotoxicity program for international drug monitoring clinical trials observational studies laboratory studies |
description |
Introduction: Several drugs were withdrawn from the market due to safety. Objective: The aim of this study was to describe data supporting drug withdrawal from the market due to safety reasons in countries belonging to the World Health Organization. Methods: We analyzed drugs withdrawn from the market between 1990 and 2010. All medicine agencies of the countries belonging to the Program for International Drug Monitoring of the World Health Organization were contacted. To complete data, Medline, reference books and available drug databases were also searched. Information sources on which authorities based their withdrawal were categorized and the average time between the first date of exposure and withdrawal was calculated and stratified. Results: A total of 133 drugs that met the inclusion/exclusion criteria were withdrawn from the market due to safety reasons in the period reviewed (1990 - 2010). Hepatotoxicity (n=36, 27.1%), cardiac disorders (n=25, 18.8%), hypersensitivity (n=17, 12.8%) and nephrotoxicity (n=14, 9.8%) were the major reasons responsible for 69.2% of all drugs withdrawn. In most cases, Information Sources for drug withdrawal were spontaneous reports and/or case reports (n=86, 64.7%), followed by clinical trials (n=24, 18.0%). The average time between the introduction of a drug and its withdrawal due to safety reasons was 20.3 years (SD±13.8). Conclusion: According to available and published evidence, there is no gold standard to identify risks associated with drug exposure. These findings strengthen the role of different information sources within the drug safety review process. |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-01-01T00:00:00Z 2022-06-18T18:51:00Z 2022-06-18 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10400.26/41110 http://hdl.handle.net/10400.26/41110 https://doi.org/10.2174/1574886314666191004092520 |
url |
http://hdl.handle.net/10400.26/41110 https://doi.org/10.2174/1574886314666191004092520 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Craveiro NS, Lopes BS, Tomás L, Almeida SF. Drug Withdrawal Due to Safety: A Review of the Data Supporting Withdrawal Decision. Curr Drug Saf. 2020;15(1):4-12. doi:10.2174/1574886314666191004092520 1574-8863 http://www.eurekaselect.com/article/101171 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.publisher.none.fl_str_mv |
Bentham Science Publishers |
publisher.none.fl_str_mv |
Bentham Science Publishers |
dc.source.none.fl_str_mv |
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
instacron_str |
RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
collection |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository.name.fl_str_mv |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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1799137168529031168 |