Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003–2012
Identifieur interne : 000006 ( Main/Exploration ); précédent : 000005; suivant : 000007Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003–2012
Auteurs : Carmen K. Wong [Australie] ; Nathaniel S. Marshall [Australie] ; Ronald R. Grunstein [Australie] ; Samuel S. Ho [Australie] ; Romano A. Fois [Australie] ; David E. Hibbs [Australie] ; Jane R. Hanrahan [Australie] ; Bandana Saini [Australie]Source :
- Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine [ 1550-9389 ] ; 2017.
Abstract
Stimulated reporting occurs when patients and healthcare professionals are influenced or “stimulated” by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. Among countries where the non-benzodiazepine hypnotic drug zolpidem is marketed, the United States experienced a comparable surge of media reporting during 2006–2009 linking the above drug with the development of complex neuropsychiatric sleep-related behaviors. However, the effect of this stimulated reporting in the United States Food and Drug Administration Adverse Event Reporting System has not been explored.
Using disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomnia, movement-based parasomnia, nonmovement-based parasomnia, amnesia, hallucination, and suicidality were determined and compared to all other medications in the database, followed by specific comparison to the benzodiazepine hypnotic class, year-by-year from 2003 to 2012.
Odds ratios were increased significantly during and after the period of media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction (ADR) reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations, and suicidality compared to all other drugs, even before the media publicity cluster.
Although our results indicate that zolpidem reports have higher odds for the ADR of interest even before the media publicity cluster, negative media coverage greatly exacerbated the reporting of these adverse reactions. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are made by health professionals or regulatory bodies.
Wong CK, Marshall NS, Grunstein RR, Ho SS, Fois RA, Hibbs DE, Hanrahan JR, Saini B. Spontaneous adverse event reports associated with zolpidem in the United States 2003–2012.
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DOI: 10.5664/jcsm.6452
PubMed: 27784418
PubMed Central: 5263078
Affiliations:
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Wong</name><affiliation wicri:level="4"><nlm:aff id="aff1">Faculty of Pharmacy, The University of Sydney, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Faculty of Pharmacy, The University of Sydney, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Marshall, Nathaniel S" sort="Marshall, Nathaniel S" uniqKey="Marshall N" first="Nathaniel S." last="Marshall">Nathaniel S. Marshall</name><affiliation wicri:level="3"><nlm:aff id="aff2">NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS) and NeuroSleep Centre, Woolcock Institute of Medical Research, The University of Sydney and Sydney Local Health District, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS) and NeuroSleep Centre, Woolcock Institute of Medical Research, The University of Sydney and Sydney Local Health District, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="aff3">Sydney Nursing School, The University of Sydney, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Sydney Nursing School, The University of Sydney, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Grunstein, Ronald R" sort="Grunstein, Ronald R" uniqKey="Grunstein R" first="Ronald R." last="Grunstein">Ronald R. Grunstein</name><affiliation wicri:level="3"><nlm:aff id="aff2">NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS) and NeuroSleep Centre, Woolcock Institute of Medical Research, The University of Sydney and Sydney Local Health District, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS) and NeuroSleep Centre, Woolcock Institute of Medical Research, The University of Sydney and Sydney Local Health District, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Ho, Samuel S" sort="Ho, Samuel S" uniqKey="Ho S" first="Samuel S." last="Ho">Samuel S. Ho</name><affiliation wicri:level="4"><nlm:aff id="aff1">Faculty of Pharmacy, The University of Sydney, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Faculty of Pharmacy, The University of Sydney, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Fois, Romano A" sort="Fois, Romano A" uniqKey="Fois R" first="Romano A." last="Fois">Romano A. Fois</name><affiliation wicri:level="4"><nlm:aff id="aff1">Faculty of Pharmacy, The University of Sydney, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Faculty of Pharmacy, The University of Sydney, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Hibbs, David E" sort="Hibbs, David E" uniqKey="Hibbs D" first="David E." last="Hibbs">David E. Hibbs</name><affiliation wicri:level="4"><nlm:aff id="aff1">Faculty of Pharmacy, The University of Sydney, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Faculty of Pharmacy, The University of Sydney, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Hanrahan, Jane R" sort="Hanrahan, Jane R" uniqKey="Hanrahan J" first="Jane R." last="Hanrahan">Jane R. Hanrahan</name><affiliation wicri:level="4"><nlm:aff id="aff1">Faculty of Pharmacy, The University of Sydney, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Faculty of Pharmacy, The University of Sydney, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Saini, Bandana" sort="Saini, Bandana" uniqKey="Saini B" first="Bandana" last="Saini">Bandana Saini</name><affiliation wicri:level="4"><nlm:aff id="aff1">Faculty of Pharmacy, The University of Sydney, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Faculty of Pharmacy, The University of Sydney, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName><orgName type="university">Université de Sydney</orgName></affiliation><affiliation wicri:level="3"><nlm:aff id="aff2">NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS) and NeuroSleep Centre, Woolcock Institute of Medical Research, The University of Sydney and Sydney Local Health District, Sydney, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS) and NeuroSleep Centre, Woolcock Institute of Medical Research, The University of Sydney and Sydney Local Health District, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author></analytic><series><title level="j">Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine</title><idno type="ISSN">1550-9389</idno><idno type="eISSN">1550-9397</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Study Objectives:</title><p>Stimulated reporting occurs when patients and healthcare professionals are influenced or “stimulated” by media publicity to report specific drug-related adverse reactions, significantly biasing pharmacovigilance analyses. Among countries where the non-benzodiazepine hypnotic drug zolpidem is marketed, the United States experienced a comparable surge of media reporting during 2006–2009 linking the above drug with the development of complex neuropsychiatric sleep-related behaviors. However, the effect of this stimulated reporting in the United States Food and Drug Administration Adverse Event Reporting System has not been explored.</p></sec><sec><title>Methods:</title><p>Using disproportionality analyses, reporting odds ratios for zolpidem exposure and the following adverse events; parasomnia, movement-based parasomnia, nonmovement-based parasomnia, amnesia, hallucination, and suicidality were determined and compared to all other medications in the database, followed by specific comparison to the benzodiazepine hypnotic class, year-by-year from 2003 to 2012.</p></sec><sec><title>Results:</title><p>Odds ratios were increased significantly during and after the period of media publicity for parasomnias, movement-based parasomnias, amnesias and hallucinations. We also observed that zolpidem adverse drug reaction (ADR) reports have higher odds for parasomnias, movement-based parasomnias, amnesias, hallucinations, and suicidality compared to all other drugs, even before the media publicity cluster.</p></sec><sec><title>Conclusions:</title><p>Although our results indicate that zolpidem reports have higher odds for the ADR of interest even before the media publicity cluster, negative media coverage greatly exacerbated the reporting of these adverse reactions. The effect of such reporting must be borne in mind when decisions around drugs which have been the subject of intense media publicity are made by health professionals or regulatory bodies.</p></sec><sec><title>Citation:</title><p>Wong CK, Marshall NS, Grunstein RR, Ho SS, Fois RA, Hibbs DE, Hanrahan JR, Saini B. Spontaneous adverse event reports associated with zolpidem in the United States 2003–2012. <italic>J Clin Sleep Med.</italic> 2017;13(2):223–234.</p></sec></div></front></TEI><affiliations><list><country><li>Australie</li></country><region><li>Nouvelle-Galles du Sud</li></region><settlement><li>Sydney</li></settlement><orgName><li>Université de Sydney</li></orgName></list><tree><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Wong, Carmen K" sort="Wong, Carmen K" uniqKey="Wong C" first="Carmen K." last="Wong">Carmen K. Wong</name></region><name sortKey="Fois, Romano A" sort="Fois, Romano A" uniqKey="Fois R" first="Romano A." last="Fois">Romano A. Fois</name><name sortKey="Grunstein, Ronald R" sort="Grunstein, Ronald R" uniqKey="Grunstein R" first="Ronald R." last="Grunstein">Ronald R. Grunstein</name><name sortKey="Hanrahan, Jane R" sort="Hanrahan, Jane R" uniqKey="Hanrahan J" first="Jane R." last="Hanrahan">Jane R. Hanrahan</name><name sortKey="Hibbs, David E" sort="Hibbs, David E" uniqKey="Hibbs D" first="David E." last="Hibbs">David E. Hibbs</name><name sortKey="Ho, Samuel S" sort="Ho, Samuel S" uniqKey="Ho S" first="Samuel S." last="Ho">Samuel S. Ho</name><name sortKey="Marshall, Nathaniel S" sort="Marshall, Nathaniel S" uniqKey="Marshall N" first="Nathaniel S." last="Marshall">Nathaniel S. Marshall</name><name sortKey="Marshall, Nathaniel S" sort="Marshall, Nathaniel S" uniqKey="Marshall N" first="Nathaniel S." last="Marshall">Nathaniel S. Marshall</name><name sortKey="Saini, Bandana" sort="Saini, Bandana" uniqKey="Saini B" first="Bandana" last="Saini">Bandana Saini</name><name sortKey="Saini, Bandana" sort="Saini, Bandana" uniqKey="Saini B" first="Bandana" last="Saini">Bandana Saini</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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