Lessons from gefitinib-induced interstitial lung disease in Japan: Problems in approval, pharmacovigilance, and regulatory decision-making procedures
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| Format: | Artículo científico |
| Language: | en |
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Centro de investigaciones y Publicaciones Farmacéuticas
2006
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| author | Tsutomu Nishimura |
| author_facet | Tsutomu Nishimura |
| contents | Lessons from gefitinib-induced interstitial lung disease in Japan: Problems in approval, pharmacovigilance, and regulatory decision-making procedures Tsutomu Nishimura Harue Tada Masatsugu Nakagawa Satoshi Teramukai Shigeyuki Matsui Masanori Fukushima Medicina Japan Gefitinib interstitial postmarketing Lung diseases Objective: The objective of this study was to identifyproblems in the approval, pharmacovigilance, andpost-approval regulatory decision-makingprocedures involving gefitinib and to proposecountermeasures to prevent further drug-inducedsuffering in Japan in the future.Methods: We comprehensively reviewed reportsregarding gefitinib published during the period from2000 to 2006 by regulatory agencies, themanufacturer of the gefitinib-containing drug, cancerclinical study groups, and a scientific society.Results: We identified the following major problemsin the approval, pharmacovigilance, and regulatorydecision-making procedures: 1) the results ofanimal experiments and pre-marketing clinical trials,and reports of adverse drug reactions from othercountries were not properly reflected in the label; 2)indications for the drug were expanded without strictevaluation of the external validity of pre-marketingclinical trials; and 3) despite many serious cases ofinterstitial lung disease (ILD) being spontaneouslyreported, well-designed post-marketing surveillancewas not immediately performed.Conclusions: We propose a mandatory total registryof all drug users and surveillance (i.e. a prospectiveoutcome study) as one of the rational solutions forpreventing further drug-induced suffering in Japan. 2006 artículo científico 1885-642X https://www.redalyc.org/articulo.oa?id=69040404 en http://www.redalyc.org/revista.oa?id=690 Pharmacy Practice application/pdf Centro de investigaciones y Publicaciones Farmacéuticas Pharmacy Practice (España) Num.4 Vol.4 |
| format | Artículo científico |
| id | redalyc_69040404 |
| institution | Redalyc |
| language | en |
| publishDate | 2006 |
| publisher | Centro de investigaciones y Publicaciones Farmacéuticas |
| spellingShingle | Lessons from gefitinib-induced interstitial lung disease in Japan: Problems in approval, pharmacovigilance, and regulatory decision-making procedures Tsutomu Nishimura Medicina Japan Gefitinib interstitial postmarketing Lung diseases Lessons from gefitinib-induced interstitial lung disease in Japan: Problems in approval, pharmacovigilance, and regulatory decision-making procedures Tsutomu Nishimura Harue Tada Masatsugu Nakagawa Satoshi Teramukai Shigeyuki Matsui Masanori Fukushima Medicina Japan Gefitinib interstitial postmarketing Lung diseases Objective: The objective of this study was to identifyproblems in the approval, pharmacovigilance, andpost-approval regulatory decision-makingprocedures involving gefitinib and to proposecountermeasures to prevent further drug-inducedsuffering in Japan in the future.Methods: We comprehensively reviewed reportsregarding gefitinib published during the period from2000 to 2006 by regulatory agencies, themanufacturer of the gefitinib-containing drug, cancerclinical study groups, and a scientific society.Results: We identified the following major problemsin the approval, pharmacovigilance, and regulatorydecision-making procedures: 1) the results ofanimal experiments and pre-marketing clinical trials,and reports of adverse drug reactions from othercountries were not properly reflected in the label; 2)indications for the drug were expanded without strictevaluation of the external validity of pre-marketingclinical trials; and 3) despite many serious cases ofinterstitial lung disease (ILD) being spontaneouslyreported, well-designed post-marketing surveillancewas not immediately performed.Conclusions: We propose a mandatory total registryof all drug users and surveillance (i.e. a prospectiveoutcome study) as one of the rational solutions forpreventing further drug-induced suffering in Japan. 2006 artículo científico 1885-642X https://www.redalyc.org/articulo.oa?id=69040404 en http://www.redalyc.org/revista.oa?id=690 Pharmacy Practice application/pdf Centro de investigaciones y Publicaciones Farmacéuticas Pharmacy Practice (España) Num.4 Vol.4 |
| title | Lessons from gefitinib-induced interstitial lung disease in Japan: Problems in approval, pharmacovigilance, and regulatory decision-making procedures |
| topic | Medicina Japan Gefitinib interstitial postmarketing Lung diseases |
| url | https://www.redalyc.org/articulo.oa?id=69040404 |