Post‐marketing safety‐related regulatory actions on first‐in‐class drugs: A double‐cohort study
What is known and objective New first‐in‐class (FIC) drugs with novel mechanisms of action may be highly effective, but lack adequate safety information, and therefore may be associated with crucial post‐marketing safety issues. The objective of this study was to evaluate the post‐marketing risk of...
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| Veröffentlicht in: | Journal of clinical pharmacy and therapeutics 2020-06, Vol.45 (3), p.496-502 |
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| creator | Ikeda, Junji Kaneko, Masayuki Narukawa, Mamoru |
| description | What is known and objective
New first‐in‐class (FIC) drugs with novel mechanisms of action may be highly effective, but lack adequate safety information, and therefore may be associated with crucial post‐marketing safety issues. The objective of this study was to evaluate the post‐marketing risk of FIC drug with comparison occurrence of Post‐marketing safety‐related regulatory actions (PSRAs) due to FIC drugs to that due to other new drugs.
Methods
A full list of all new molecular entities and therapeutic biologics, except diagnostic agents and vaccines, which were approved in the United States between 1 January 2003, and 31 December 2013, were included in this study. Drugs with novel mechanisms of action at the time of approval were classified as the FIC cohort and other new drugs as the control cohort. PSRAs were defined as safety‐related post‐marketing withdrawal, new issuance or the addition of black box warnings. Specifically, we identified PSRAs associated with adverse drug reactions (ADR‐PSRAs). Subsequently, we identified drug allergy ADR‐PSRAs and class‐effect ADR‐PSRAs, and also extracted drug‐specific ADR‐PSRAs. To evaluate the post‐marketing safety risk of FIC drugs, we estimated the odds ratio of the occurrence of ADR‐PSRAs between the FIC cohort and the control cohort.
Results and discussion
The odds ratio of the occurrence of all ADR‐PSRA in the FIC cohort was 0.96 (95% CI: 0.57‐1.61, P = .8758), showing no difference compared to that of the control cohort. However, the odds ratio of the occurrence of drug‐specific ADR‐PSRAs in the FIC cohort was 2.06 (95% CI: 1.20‐3.55, P = .0091).
What is new and conclusion
This study demonstrated that a strong relationship existed between FIC drugs and the occurrence of drug‐specific ADR‐PSRAs, suggesting that post‐marketing safety risk for FIC drugs is higher than that for other new drugs given the same class at approval.
This study demonstrated that a strong relationship existed between FIC drugs and the occurrence of drug‐specific ADR‐PSRAs, suggesting that post‐marketing safety risk for FIC drugs is higher than that for other new drugs given the same class at approval. |
| doi_str_mv | 10.1111/jcpt.13096 |
| format | Article |
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New first‐in‐class (FIC) drugs with novel mechanisms of action may be highly effective, but lack adequate safety information, and therefore may be associated with crucial post‐marketing safety issues. The objective of this study was to evaluate the post‐marketing risk of FIC drug with comparison occurrence of Post‐marketing safety‐related regulatory actions (PSRAs) due to FIC drugs to that due to other new drugs.
Methods
A full list of all new molecular entities and therapeutic biologics, except diagnostic agents and vaccines, which were approved in the United States between 1 January 2003, and 31 December 2013, were included in this study. Drugs with novel mechanisms of action at the time of approval were classified as the FIC cohort and other new drugs as the control cohort. PSRAs were defined as safety‐related post‐marketing withdrawal, new issuance or the addition of black box warnings. Specifically, we identified PSRAs associated with adverse drug reactions (ADR‐PSRAs). Subsequently, we identified drug allergy ADR‐PSRAs and class‐effect ADR‐PSRAs, and also extracted drug‐specific ADR‐PSRAs. To evaluate the post‐marketing safety risk of FIC drugs, we estimated the odds ratio of the occurrence of ADR‐PSRAs between the FIC cohort and the control cohort.
Results and discussion
The odds ratio of the occurrence of all ADR‐PSRA in the FIC cohort was 0.96 (95% CI: 0.57‐1.61, P = .8758), showing no difference compared to that of the control cohort. However, the odds ratio of the occurrence of drug‐specific ADR‐PSRAs in the FIC cohort was 2.06 (95% CI: 1.20‐3.55, P = .0091).
What is new and conclusion
This study demonstrated that a strong relationship existed between FIC drugs and the occurrence of drug‐specific ADR‐PSRAs, suggesting that post‐marketing safety risk for FIC drugs is higher than that for other new drugs given the same class at approval.
This study demonstrated that a strong relationship existed between FIC drugs and the occurrence of drug‐specific ADR‐PSRAs, suggesting that post‐marketing safety risk for FIC drugs is higher than that for other new drugs given the same class at approval.</description><identifier>ISSN: 0269-4727</identifier><identifier>EISSN: 1365-2710</identifier><identifier>DOI: 10.1111/jcpt.13096</identifier><identifier>PMID: 31846100</identifier><language>eng</language><publisher>England: Hindawi Limited</publisher><subject>adverse drug reaction ; Adverse Drug Reaction Reporting Systems ; Allergies ; Biological Products - adverse effects ; Cohort analysis ; Cohort Studies ; Diagnostic agents ; Drug Approval ; Drug Labeling ; Drugs ; first‐in‐class ; Humans ; Marketing ; Safety ; Safety-Based Drug Withdrawals ; safety‐related regulatory action ; United States ; United States Food and Drug Administration - legislation & jurisprudence ; US Food and Drug Administration</subject><ispartof>Journal of clinical pharmacy and therapeutics, 2020-06, Vol.45 (3), p.496-502</ispartof><rights>2019 John Wiley & Sons Ltd</rights><rights>2019 John Wiley & Sons Ltd.</rights><rights>Copyright © 2020 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3936-77fa5fcb2ad44ab6cd54119a251a524be7bdfb88abf6e98d0cc90892ccefb56f3</citedby><cites>FETCH-LOGICAL-c3936-77fa5fcb2ad44ab6cd54119a251a524be7bdfb88abf6e98d0cc90892ccefb56f3</cites><orcidid>0000-0003-2647-4602</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjcpt.13096$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjcpt.13096$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1416,27923,27924,45573,45574</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31846100$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ikeda, Junji</creatorcontrib><creatorcontrib>Kaneko, Masayuki</creatorcontrib><creatorcontrib>Narukawa, Mamoru</creatorcontrib><title>Post‐marketing safety‐related regulatory actions on first‐in‐class drugs: A double‐cohort study</title><title>Journal of clinical pharmacy and therapeutics</title><addtitle>J Clin Pharm Ther</addtitle><description>What is known and objective
New first‐in‐class (FIC) drugs with novel mechanisms of action may be highly effective, but lack adequate safety information, and therefore may be associated with crucial post‐marketing safety issues. The objective of this study was to evaluate the post‐marketing risk of FIC drug with comparison occurrence of Post‐marketing safety‐related regulatory actions (PSRAs) due to FIC drugs to that due to other new drugs.
Methods
A full list of all new molecular entities and therapeutic biologics, except diagnostic agents and vaccines, which were approved in the United States between 1 January 2003, and 31 December 2013, were included in this study. Drugs with novel mechanisms of action at the time of approval were classified as the FIC cohort and other new drugs as the control cohort. PSRAs were defined as safety‐related post‐marketing withdrawal, new issuance or the addition of black box warnings. Specifically, we identified PSRAs associated with adverse drug reactions (ADR‐PSRAs). Subsequently, we identified drug allergy ADR‐PSRAs and class‐effect ADR‐PSRAs, and also extracted drug‐specific ADR‐PSRAs. To evaluate the post‐marketing safety risk of FIC drugs, we estimated the odds ratio of the occurrence of ADR‐PSRAs between the FIC cohort and the control cohort.
Results and discussion
The odds ratio of the occurrence of all ADR‐PSRA in the FIC cohort was 0.96 (95% CI: 0.57‐1.61, P = .8758), showing no difference compared to that of the control cohort. However, the odds ratio of the occurrence of drug‐specific ADR‐PSRAs in the FIC cohort was 2.06 (95% CI: 1.20‐3.55, P = .0091).
What is new and conclusion
This study demonstrated that a strong relationship existed between FIC drugs and the occurrence of drug‐specific ADR‐PSRAs, suggesting that post‐marketing safety risk for FIC drugs is higher than that for other new drugs given the same class at approval.
This study demonstrated that a strong relationship existed between FIC drugs and the occurrence of drug‐specific ADR‐PSRAs, suggesting that post‐marketing safety risk for FIC drugs is higher than that for other new drugs given the same class at approval.</description><subject>adverse drug reaction</subject><subject>Adverse Drug Reaction Reporting Systems</subject><subject>Allergies</subject><subject>Biological Products - adverse effects</subject><subject>Cohort analysis</subject><subject>Cohort Studies</subject><subject>Diagnostic agents</subject><subject>Drug Approval</subject><subject>Drug Labeling</subject><subject>Drugs</subject><subject>first‐in‐class</subject><subject>Humans</subject><subject>Marketing</subject><subject>Safety</subject><subject>Safety-Based Drug Withdrawals</subject><subject>safety‐related regulatory action</subject><subject>United States</subject><subject>United States Food and Drug Administration - legislation & jurisprudence</subject><subject>US Food and Drug Administration</subject><issn>0269-4727</issn><issn>1365-2710</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMtKxDAUhoMoOl42PoAE3AnVXNq0cTcMXhnQha5LrmPHTjMmKdKdj-Az-iRmnNGlZ5ETfr78gQ-AY4zOcZqLuVrGc0wRZ1tghCkrMlJitA1GiDCe5SUp98B-CHOEECsJ3QV7FFc5wwiNQPPoQvz6-FwI_2pi081gENbEIUXetCIaDb2Z9enm_ACFio3rAnQdtI3_edh06VCtCAFq38_CJRxD7XrZmlXuXpyPMMReD4dgx4o2mKPNPgDP11dPk9ts-nBzNxlPM0U5ZVlZWlFYJYnQeS4kU7rIMeaCFFgUJJemlNrKqhLSMsMrjZTiqOJEKWNlwSw9AKfr3qV3b70JsZ673nfpy5pQXjLKC0oTdbamlHcheGPrpW-ShKHGqF5ZrVdW6x-rCT7ZVPZyYfQf-qsxAXgNvDetGf6pqu8nj0_r0m_LMonZ</recordid><startdate>202006</startdate><enddate>202006</enddate><creator>Ikeda, Junji</creator><creator>Kaneko, Masayuki</creator><creator>Narukawa, Mamoru</creator><general>Hindawi Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><orcidid>https://orcid.org/0000-0003-2647-4602</orcidid></search><sort><creationdate>202006</creationdate><title>Post‐marketing safety‐related regulatory actions on first‐in‐class drugs: A double‐cohort study</title><author>Ikeda, Junji ; Kaneko, Masayuki ; Narukawa, Mamoru</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3936-77fa5fcb2ad44ab6cd54119a251a524be7bdfb88abf6e98d0cc90892ccefb56f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>adverse drug reaction</topic><topic>Adverse Drug Reaction Reporting Systems</topic><topic>Allergies</topic><topic>Biological Products - adverse effects</topic><topic>Cohort analysis</topic><topic>Cohort Studies</topic><topic>Diagnostic agents</topic><topic>Drug Approval</topic><topic>Drug Labeling</topic><topic>Drugs</topic><topic>first‐in‐class</topic><topic>Humans</topic><topic>Marketing</topic><topic>Safety</topic><topic>Safety-Based Drug Withdrawals</topic><topic>safety‐related regulatory action</topic><topic>United States</topic><topic>United States Food and Drug Administration - legislation & jurisprudence</topic><topic>US Food and Drug Administration</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ikeda, Junji</creatorcontrib><creatorcontrib>Kaneko, Masayuki</creatorcontrib><creatorcontrib>Narukawa, Mamoru</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><jtitle>Journal of clinical pharmacy and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ikeda, Junji</au><au>Kaneko, Masayuki</au><au>Narukawa, Mamoru</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Post‐marketing safety‐related regulatory actions on first‐in‐class drugs: A double‐cohort study</atitle><jtitle>Journal of clinical pharmacy and therapeutics</jtitle><addtitle>J Clin Pharm Ther</addtitle><date>2020-06</date><risdate>2020</risdate><volume>45</volume><issue>3</issue><spage>496</spage><epage>502</epage><pages>496-502</pages><issn>0269-4727</issn><eissn>1365-2710</eissn><abstract>What is known and objective
New first‐in‐class (FIC) drugs with novel mechanisms of action may be highly effective, but lack adequate safety information, and therefore may be associated with crucial post‐marketing safety issues. The objective of this study was to evaluate the post‐marketing risk of FIC drug with comparison occurrence of Post‐marketing safety‐related regulatory actions (PSRAs) due to FIC drugs to that due to other new drugs.
Methods
A full list of all new molecular entities and therapeutic biologics, except diagnostic agents and vaccines, which were approved in the United States between 1 January 2003, and 31 December 2013, were included in this study. Drugs with novel mechanisms of action at the time of approval were classified as the FIC cohort and other new drugs as the control cohort. PSRAs were defined as safety‐related post‐marketing withdrawal, new issuance or the addition of black box warnings. Specifically, we identified PSRAs associated with adverse drug reactions (ADR‐PSRAs). Subsequently, we identified drug allergy ADR‐PSRAs and class‐effect ADR‐PSRAs, and also extracted drug‐specific ADR‐PSRAs. To evaluate the post‐marketing safety risk of FIC drugs, we estimated the odds ratio of the occurrence of ADR‐PSRAs between the FIC cohort and the control cohort.
Results and discussion
The odds ratio of the occurrence of all ADR‐PSRA in the FIC cohort was 0.96 (95% CI: 0.57‐1.61, P = .8758), showing no difference compared to that of the control cohort. However, the odds ratio of the occurrence of drug‐specific ADR‐PSRAs in the FIC cohort was 2.06 (95% CI: 1.20‐3.55, P = .0091).
What is new and conclusion
This study demonstrated that a strong relationship existed between FIC drugs and the occurrence of drug‐specific ADR‐PSRAs, suggesting that post‐marketing safety risk for FIC drugs is higher than that for other new drugs given the same class at approval.
This study demonstrated that a strong relationship existed between FIC drugs and the occurrence of drug‐specific ADR‐PSRAs, suggesting that post‐marketing safety risk for FIC drugs is higher than that for other new drugs given the same class at approval.</abstract><cop>England</cop><pub>Hindawi Limited</pub><pmid>31846100</pmid><doi>10.1111/jcpt.13096</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0003-2647-4602</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of clinical pharmacy and therapeutics, 2020-06, Vol.45 (3), p.496-502 |
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| source | MEDLINE; Wiley Online Library All Journals |
| subjects | adverse drug reaction Adverse Drug Reaction Reporting Systems Allergies Biological Products - adverse effects Cohort analysis Cohort Studies Diagnostic agents Drug Approval Drug Labeling Drugs first‐in‐class Humans Marketing Safety Safety-Based Drug Withdrawals safety‐related regulatory action United States United States Food and Drug Administration - legislation & jurisprudence US Food and Drug Administration |
| title | Post‐marketing safety‐related regulatory actions on first‐in‐class drugs: A double‐cohort study |
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