Timing of New Black Box Warnings and Withdrawals for Prescription Medications
CONTEXT Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs. OBJECTIVE To determine the frequency and timing of discovery of new A...
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Veröffentlicht in: | JAMA : the journal of the American Medical Association 2002-05, Vol.287 (17), p.2215-2220 |
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container_title | JAMA : the journal of the American Medical Association |
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creator | Lasser, Karen E Allen, Paul D Woolhandler, Steffie J Himmelstein, David U Wolfe, Sidney M Bor, David H |
description | CONTEXT Recently approved drugs may be more likely to have unrecognized adverse
drug reactions (ADRs) than established drugs, but no recent studies have examined
how frequently postmarketing surveillance identifies important ADRs. OBJECTIVE To determine the frequency and timing of discovery of new ADRs described
in black box warnings or necessitating withdrawal of the drug from the market. DESIGN AND SETTING Examination of the Physicians' Desk Reference
for all new chemical entities approved by the US Food and Drug Administration
between 1975 and 1999, and all drugs withdrawn from the market between 1975
and 2000 (with or without a prior black box warning). MAIN OUTCOME MEASURES Frequency of and time to a new black box warning or drug withdrawal. RESULTS A total of 548 new chemical entities were approved in 1975-1999; 56
(10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs
(8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn
from the market. In Kaplan-Meier analyses, the estimated probability of acquiring
a new black box warning or being withdrawn from the market over 25 years was
20%. Eighty-one major changes to drug labeling in the Physicians'
Desk Reference occurred including the addition of 1 or more black box
warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these
changes occurred within 7 years of drug introduction; half of the withdrawals
occurred within 2 years. CONCLUSIONS Serious ADRs commonly emerge after Food and Drug Administration approval.
The safety of new agents cannot be known with certainty until a drug has been
on the market for many years. |
doi_str_mv | 10.1001/jama.287.17.2215 |
format | Article |
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drug reactions (ADRs) than established drugs, but no recent studies have examined
how frequently postmarketing surveillance identifies important ADRs. OBJECTIVE To determine the frequency and timing of discovery of new ADRs described
in black box warnings or necessitating withdrawal of the drug from the market. DESIGN AND SETTING Examination of the Physicians' Desk Reference
for all new chemical entities approved by the US Food and Drug Administration
between 1975 and 1999, and all drugs withdrawn from the market between 1975
and 2000 (with or without a prior black box warning). MAIN OUTCOME MEASURES Frequency of and time to a new black box warning or drug withdrawal. RESULTS A total of 548 new chemical entities were approved in 1975-1999; 56
(10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs
(8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn
from the market. In Kaplan-Meier analyses, the estimated probability of acquiring
a new black box warning or being withdrawn from the market over 25 years was
20%. Eighty-one major changes to drug labeling in the Physicians'
Desk Reference occurred including the addition of 1 or more black box
warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these
changes occurred within 7 years of drug introduction; half of the withdrawals
occurred within 2 years. CONCLUSIONS Serious ADRs commonly emerge after Food and Drug Administration approval.
The safety of new agents cannot be known with certainty until a drug has been
on the market for many years.</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.287.17.2215</identifier><identifier>PMID: 11980521</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Adverse Drug Reaction Reporting Systems ; Biological and medical sciences ; Descriptive labeling ; Dictionaries, Pharmaceutic as Topic ; Drug and Narcotic Control - statistics & numerical data ; Drug Approval ; Drug Labeling ; Drug-Related Side Effects and Adverse Reactions ; Legislation, Drug ; Medical sciences ; Miscellaneous ; Pharmaceuticals ; Pharmacology. Drug treatments ; Product recalls ; Product safety ; Side effects ; Survival Analysis ; United States ; United States Food and Drug Administration</subject><ispartof>JAMA : the journal of the American Medical Association, 2002-05, Vol.287 (17), p.2215-2220</ispartof><rights>2002 INIST-CNRS</rights><rights>Copyright American Medical Association May 1, 2002</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a462t-bbd16c55feab3ad93949de7391b8c553935c967265db59595f016cc4a6c50a7d3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.287.17.2215$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.287.17.2215$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,780,784,3340,27924,27925,76489,76492</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13642335$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11980521$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lasser, Karen E</creatorcontrib><creatorcontrib>Allen, Paul D</creatorcontrib><creatorcontrib>Woolhandler, Steffie J</creatorcontrib><creatorcontrib>Himmelstein, David U</creatorcontrib><creatorcontrib>Wolfe, Sidney M</creatorcontrib><creatorcontrib>Bor, David H</creatorcontrib><title>Timing of New Black Box Warnings and Withdrawals for Prescription Medications</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>CONTEXT Recently approved drugs may be more likely to have unrecognized adverse
drug reactions (ADRs) than established drugs, but no recent studies have examined
how frequently postmarketing surveillance identifies important ADRs. OBJECTIVE To determine the frequency and timing of discovery of new ADRs described
in black box warnings or necessitating withdrawal of the drug from the market. DESIGN AND SETTING Examination of the Physicians' Desk Reference
for all new chemical entities approved by the US Food and Drug Administration
between 1975 and 1999, and all drugs withdrawn from the market between 1975
and 2000 (with or without a prior black box warning). MAIN OUTCOME MEASURES Frequency of and time to a new black box warning or drug withdrawal. RESULTS A total of 548 new chemical entities were approved in 1975-1999; 56
(10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs
(8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn
from the market. In Kaplan-Meier analyses, the estimated probability of acquiring
a new black box warning or being withdrawn from the market over 25 years was
20%. Eighty-one major changes to drug labeling in the Physicians'
Desk Reference occurred including the addition of 1 or more black box
warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these
changes occurred within 7 years of drug introduction; half of the withdrawals
occurred within 2 years. CONCLUSIONS Serious ADRs commonly emerge after Food and Drug Administration approval.
The safety of new agents cannot be known with certainty until a drug has been
on the market for many years.</description><subject>Adverse Drug Reaction Reporting Systems</subject><subject>Biological and medical sciences</subject><subject>Descriptive labeling</subject><subject>Dictionaries, Pharmaceutic as Topic</subject><subject>Drug and Narcotic Control - statistics & numerical data</subject><subject>Drug Approval</subject><subject>Drug Labeling</subject><subject>Drug-Related Side Effects and Adverse Reactions</subject><subject>Legislation, Drug</subject><subject>Medical sciences</subject><subject>Miscellaneous</subject><subject>Pharmaceuticals</subject><subject>Pharmacology. Drug treatments</subject><subject>Product recalls</subject><subject>Product safety</subject><subject>Side effects</subject><subject>Survival Analysis</subject><subject>United States</subject><subject>United States Food and Drug Administration</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpF0M1PwjAUAPDGaATRu15MY-Jxs59bexTiVwLqAcNxeVs7LcKG7Qj631sDhvcOr3nv1zYtQueUpJQQejOHJaRM5SnNU8aoPEB9KrlKuNTqEPUJ0SrJhRI9dBLCnMSgPD9GPUq1IpLRPppM3dI177it8bPd4OECqk88bL_xDHwTBwFDY_DMdR_GwwYWAdetx6_ehsq7VefaBk-scRX8LcMpOqqjsWe7OkBv93fT0WMyfnl4Gt2OExAZ65KyNDSrpKwtlByM5lpoY3Ouaalim2suK53lLJOmlDpmTaKvBMRNBHLDB-hqe-7Kt19rG7pi3q59E68sGKVcMMVFRJc7tC6X1hQr75bgf4r_x0dwvQMQKljUHprKhb3jmWCcy-guti7-9n6qhco1_wXgDHBV</recordid><startdate>20020501</startdate><enddate>20020501</enddate><creator>Lasser, Karen E</creator><creator>Allen, Paul D</creator><creator>Woolhandler, Steffie J</creator><creator>Himmelstein, David U</creator><creator>Wolfe, Sidney M</creator><creator>Bor, David H</creator><general>American Medical Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope></search><sort><creationdate>20020501</creationdate><title>Timing of New Black Box Warnings and Withdrawals for Prescription Medications</title><author>Lasser, Karen E ; Allen, Paul D ; Woolhandler, Steffie J ; Himmelstein, David U ; Wolfe, Sidney M ; Bor, David H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a462t-bbd16c55feab3ad93949de7391b8c553935c967265db59595f016cc4a6c50a7d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Adverse Drug Reaction Reporting Systems</topic><topic>Biological and medical sciences</topic><topic>Descriptive labeling</topic><topic>Dictionaries, Pharmaceutic as Topic</topic><topic>Drug and Narcotic Control - statistics & numerical data</topic><topic>Drug Approval</topic><topic>Drug Labeling</topic><topic>Drug-Related Side Effects and Adverse Reactions</topic><topic>Legislation, Drug</topic><topic>Medical sciences</topic><topic>Miscellaneous</topic><topic>Pharmaceuticals</topic><topic>Pharmacology. Drug treatments</topic><topic>Product recalls</topic><topic>Product safety</topic><topic>Side effects</topic><topic>Survival Analysis</topic><topic>United States</topic><topic>United States Food and Drug Administration</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lasser, Karen E</creatorcontrib><creatorcontrib>Allen, Paul D</creatorcontrib><creatorcontrib>Woolhandler, Steffie J</creatorcontrib><creatorcontrib>Himmelstein, David U</creatorcontrib><creatorcontrib>Wolfe, Sidney M</creatorcontrib><creatorcontrib>Bor, David H</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lasser, Karen E</au><au>Allen, Paul D</au><au>Woolhandler, Steffie J</au><au>Himmelstein, David U</au><au>Wolfe, Sidney M</au><au>Bor, David H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Timing of New Black Box Warnings and Withdrawals for Prescription Medications</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2002-05-01</date><risdate>2002</risdate><volume>287</volume><issue>17</issue><spage>2215</spage><epage>2220</epage><pages>2215-2220</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><abstract>CONTEXT Recently approved drugs may be more likely to have unrecognized adverse
drug reactions (ADRs) than established drugs, but no recent studies have examined
how frequently postmarketing surveillance identifies important ADRs. OBJECTIVE To determine the frequency and timing of discovery of new ADRs described
in black box warnings or necessitating withdrawal of the drug from the market. DESIGN AND SETTING Examination of the Physicians' Desk Reference
for all new chemical entities approved by the US Food and Drug Administration
between 1975 and 1999, and all drugs withdrawn from the market between 1975
and 2000 (with or without a prior black box warning). MAIN OUTCOME MEASURES Frequency of and time to a new black box warning or drug withdrawal. RESULTS A total of 548 new chemical entities were approved in 1975-1999; 56
(10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs
(8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn
from the market. In Kaplan-Meier analyses, the estimated probability of acquiring
a new black box warning or being withdrawn from the market over 25 years was
20%. Eighty-one major changes to drug labeling in the Physicians'
Desk Reference occurred including the addition of 1 or more black box
warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these
changes occurred within 7 years of drug introduction; half of the withdrawals
occurred within 2 years. CONCLUSIONS Serious ADRs commonly emerge after Food and Drug Administration approval.
The safety of new agents cannot be known with certainty until a drug has been
on the market for many years.</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>11980521</pmid><doi>10.1001/jama.287.17.2215</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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language | eng |
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source | MEDLINE; American Medical Association Journals |
subjects | Adverse Drug Reaction Reporting Systems Biological and medical sciences Descriptive labeling Dictionaries, Pharmaceutic as Topic Drug and Narcotic Control - statistics & numerical data Drug Approval Drug Labeling Drug-Related Side Effects and Adverse Reactions Legislation, Drug Medical sciences Miscellaneous Pharmaceuticals Pharmacology. Drug treatments Product recalls Product safety Side effects Survival Analysis United States United States Food and Drug Administration |
title | Timing of New Black Box Warnings and Withdrawals for Prescription Medications |
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