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Bupropion and the risk of sudden death: a self-controlled case-series analysis using The Health Improvement Network | Thorax
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Methods: Data for all patients prescribed bupropion within The Health Improvement Network (a computerised general practice database) were extracted and the self-controlled case-series method was used to estimate the relative incidence of death during the first 28 days of treatment. The incidence of seizures, a recognised adverse effect of bupropion, was also investigated during this period. Results: A total of 9329 individuals had been prescribed bupropion (mean age 44 years, 48% male). The total person-time after the first prescription for bupropion was 17 586 years, and during this time 121 people died. Two people died within the first 28 days of treatment, which was less than expected in comparison with the remaining observation period by an incidence ratio of 0.50 (95% confidence interval (CI) 0.12 to 2.05). Twenty eight people were recorded as having a total of 45 seizures (23 before starting bupropion, two in the first 28 days of treatment, and 20 at a later point). The relative incidence of seizures during the first 28 days of treatment was 3.62 (95% CI 0.87 to 15.09), equivalent to one additional seizure per 6219 first time bupropion users. Conclusions: Bupropion use is probably associated with an increased risk of seizures, but no evidence was found to suggest that the drug is associated with an increased risk of sudden death." /> <meta name="DC.Contributor" content="R Hubbard" /> <meta name="DC.Contributor" content="S Lewis" /> <meta name="DC.Contributor" content="J West" /> <meta name="DC.Contributor" content="C Smith" /> <meta name="DC.Contributor" content="C Godfrey" /> <meta name="DC.Contributor" content="L Smeeth" /> <meta name="DC.Contributor" content="P Farrington" /> <meta name="DC.Contributor" content="J Britton" /> <meta name="article:published_time" content="2005-10-01" /> <meta name="article:section" content="Smoking cessation" /> <meta name="citation_title" content="Bupropion and the risk of sudden death: a self-controlled case-series analysis using The Health Improvement Network" /> <meta name="citation_abstract" lang="en" content="<p><b>Background:</b> Bupropion is an effective smoking cessation therapy but its use in the UK has been limited by concerns that it may increase the risk of sudden death.</p><p><b>Methods:</b> Data for all patients prescribed bupropion within The Health Improvement Network (a computerised general practice database) were extracted and the self-controlled case-series method was used to estimate the relative incidence of death during the first 28 days of treatment. The incidence of seizures, a recognised adverse effect of bupropion, was also investigated during this period.</p><p><b>Results:</b> A total of 9329 individuals had been prescribed bupropion (mean age 44 years, 48% male). The total person-time after the first prescription for bupropion was 17 586 years, and during this time 121 people died. Two people died within the first 28 days of treatment, which was less than expected in comparison with the remaining observation period by an incidence ratio of 0.50 (95% confidence interval (CI) 0.12 to 2.05). Twenty eight people were recorded as having a total of 45 seizures (23 before starting bupropion, two in the first 28 days of treatment, and 20 at a later point). The relative incidence of seizures during the first 28 days of treatment was 3.62 (95% CI 0.87 to 15.09), equivalent to one additional seizure per 6219 first time bupropion users.</p><p><b>Conclusions:</b> Bupropion use is probably associated with an increased risk of seizures, but no evidence was found to suggest that the drug is associated with an increased risk of sudden death.</p>" /> <meta name="citation_journal_title" content="Thorax" /> <meta name="citation_publisher" content="BMJ Publishing Group Ltd" /> <meta name="citation_publication_date" content="2005/10/01" /> <meta name="citation_mjid" content="thoraxjnl;60/10/848" /> <meta name="citation_id" content="60/10/848" /> <meta name="citation_public_url" content="https://thorax.bmj.com/content/60/10/848" /> <meta name="citation_abstract_html_url" content="https://thorax.bmj.com/content/60/10/848.abstract" /> <meta name="citation_full_html_url" content="https://thorax.bmj.com/content/60/10/848.full" /> <meta 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name="citation_reference" content="citation_title=Cochrane Database Syst Rev;citation_pages=CD000031;citation_year=2004" /> <meta name="citation_reference" content="citation_title=European journal of clinical pharmacology;citation_journal_abbrev=Eur J Clin Pharmacol;citation_title=Evaluation of the safety of bupropion (Zyban) for smoking cessation from experience gained in general practice use in England in 2000.;citation_pages=767-773;citation_volume=59;citation_year=2003;citation_issue=10;citation_pmid=14615857;citation_doi=10.1007/s00228-003-0693-0" /> <meta name="twitter:title" content="Bupropion and the risk of sudden death: a self-controlled case-series analysis using The Health Improvement Network" /> <meta name="twitter:card" content="summary_large_image" /> <meta name="twitter:image" content="https://thorax.bmj.com/sites/default/files/highwire/thoraxjnl/60/10.cover.gif" /> <meta name="twitter:description" content="Background: Bupropion is an effective smoking cessation therapy but its use in the UK has been limited by concerns that it may increase the risk of sudden death. Methods: Data for all patients prescribed bupropion within The Health Improvement Network (a computerised general practice database) were extracted and the self-controlled case-series method was used to estimate the relative incidence of death during the first 28 days of treatment. The incidence of seizures, a recognised adverse effect of bupropion, was also investigated during this period. Results: A total of 9329 individuals had been prescribed bupropion (mean age 44 years, 48% male). The total person-time after the first prescription for bupropion was 17 586 years, and during this time 121 people died. Two people died within the first 28 days of treatment, which was less than expected in comparison with the remaining observation period by an incidence ratio of 0.50 (95% confidence interval (CI) 0.12 to 2.05). Twenty eight people were recorded as having a total of 45 seizures (23 before starting bupropion, two in the first 28 days of treatment, and 20 at a later point). The relative incidence of seizures during the first 28 days of treatment was 3.62 (95% CI 0.87 to 15.09), equivalent to one additional seizure per 6219 first time bupropion users. Conclusions: Bupropion use is probably associated with an increased risk of seizures, but no evidence was found to suggest that the drug is associated with an increased risk of sudden death." /> <meta name="og-title" property="og:title" content="Bupropion and the risk of sudden death: a self-controlled case-series analysis using The Health Improvement Network" /> <meta name="og-url" property="og:url" content="https://thorax.bmj.com/content/60/10/848" /> <meta name="og-site-name" property="og:site_name" content="Thorax" /> <meta name="og-description" property="og:description" content="Background: Bupropion is an effective smoking cessation therapy but its use in the UK has been limited by concerns that it may increase the risk of sudden death. Methods: Data for all patients prescribed bupropion within The Health Improvement Network (a computerised general practice database) were extracted and the self-controlled case-series method was used to estimate the relative incidence of death during the first 28 days of treatment. The incidence of seizures, a recognised adverse effect of bupropion, was also investigated during this period. Results: A total of 9329 individuals had been prescribed bupropion (mean age 44 years, 48% male). The total person-time after the first prescription for bupropion was 17 586 years, and during this time 121 people died. Two people died within the first 28 days of treatment, which was less than expected in comparison with the remaining observation period by an incidence ratio of 0.50 (95% confidence interval (CI) 0.12 to 2.05). Twenty eight people were recorded as having a total of 45 seizures (23 before starting bupropion, two in the first 28 days of treatment, and 20 at a later point). The relative incidence of seizures during the first 28 days of treatment was 3.62 (95% CI 0.87 to 15.09), equivalent to one additional seizure per 6219 first time bupropion users. Conclusions: Bupropion use is probably associated with an increased risk of seizures, but no evidence was found to suggest that the drug is associated with an increased risk of sudden death." /> <meta name="og-type" property="og:type" content="article" /> <meta name="og-image" property="og:image" content="https://thorax.bmj.com/sites/default/files/highwire/thoraxjnl/60/10.cover.gif" /> <link rel="alternate" type="application/vnd.ms-powerpoint" title="Powerpoint" href="/content/60/10/848.ppt" /> <title>Bupropion and the risk of sudden death: a self-controlled case-series analysis using The Health Improvement Network | Thorax</title> <link type="text/css" rel="stylesheet" href="/sites/default/files/advagg_css/css__QxGmTO72thjKeROM_Gj3l18NvAn--8IsCRoy1fYiu4M__XIYCORrpa1u8qww8HC0MSBX05rwK_OicLIEmHsfVRcE__UK4XtEDKdMc0Gs7HNCE9o0vU2f7Fe9vzuvoxMxYgoFA.css" media="all" /> <!-- OneTrust Cookies Consent Notice start --> <script src="https://cookie-cdn.cookiepro.com/scripttemplates/otSDKStub.js" 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class="panel-separator"></div><div class="panel-pane pane-entity-field pane-node-field-highwire-article-cat article-category col-narrow-9 col-normal-10" > <div class="pane-content"> <div class="field field-name-field-highwire-article-cat field-type-text field-label-hidden"><div class="field-items"><div class="field-item even">Smoking cessation</div></div></div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-highwire-article-citation col-mobile-10 col-narrow-10 col-normal-11 article-title" > <div class="pane-content"> <div class="highwire-article-citation highwire-citation-type-highwire-article node146297" data-node-nid="146297" id="node-146297--2608415146" data-pisa="thoraxjnl;60/10/848" data-pisa-master="thoraxjnl;thx.2005.041798" data-apath="/thoraxjnl/60/10/848.atom"><cite class="highwire-cite highwire-cite-highwire-article highwire-citation-bmjj-title clearfix"> <div class="highwire-cite-title">Bupropion and the risk of sudden death: a self-controlled case-series analysis using The Health Improvement Network</div> <span class="highwire-cite-access"><span class="highwire-citation-access highwire-citation-access-check" data-pisa-id="thoraxjnl;thx.2005.041798" data-atom-uri="/thoraxjnl/60/10/848.atom" data-request-view="full"></span></span> </cite> </div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-highwire-panel-tabs-container col-narrow-12 clear" > <div class="pane-content"> <div data-panels-ajax-tab-preloaded="jnl_template_bmjj_tab_art" id="panels-ajax-tab-container-highwire_article_tabs" class="panels-ajax-tab-container"><div class="panels-ajax-tab-loading" style ="display:none"><img class="loading" src="https://thorax.bmj.com/sites/all/modules/contrib/panels_ajax_tab/images/loading.gif" alt="Loading" title="Loading" /></div><div class="panels-ajax-tab-wrap-jnl_template_bmjj_tab_art"><div class="panel-display panel-1col clearfix" > <div class="panel-panel panel-col"> <div><div class="panel-pane pane-highwire-markup author-affiliates col-narrow-12 author-affiliates-corresp article" > <div class="pane-content"> <div class="highwire-markup"><div xmlns="http://www.w3.org/1999/xhtml" class="content-block-markup" xmlns:xhtml="http://www.w3.org/1999/xhtml"><div xmlns:xhtml="http://www.w3.org/1999/xhtml" class="contributors"><ol class="contributor-list" id="contrib-group-1"><li id="contrib-1"><span class="name">R Hubbard</span><a id="xref-aff-1-1" class="xref-aff" href="#aff-1">1</a>, </li><li id="contrib-2"><span class="name">S Lewis</span><a id="xref-aff-2-1" class="xref-aff" href="#aff-2">2</a>, </li><li id="contrib-3"><span class="name">J West</span><a id="xref-aff-1-2" class="xref-aff" href="#aff-1">1</a>, </li><li id="contrib-4"><span class="name">C Smith</span><a id="xref-aff-2-2" class="xref-aff" href="#aff-2">2</a>, </li><li id="contrib-5"><span class="name">C Godfrey</span><a id="xref-aff-3-1" class="xref-aff" href="#aff-3">3</a>, </li><li id="contrib-6"><span class="name">L Smeeth</span><a id="xref-aff-4-1" class="xref-aff" href="#aff-4">4</a>, </li><li id="contrib-7"><span class="name">P Farrington</span><a id="xref-aff-5-1" class="xref-aff" href="#aff-5">5</a>, </li><li id="contrib-8"><span class="name">J Britton</span><a id="xref-aff-1-3" class="xref-aff" href="#aff-1">1</a></li></ol><ol class="affiliation-list"><li class="aff"><a id="aff-1" name="aff-1"></a><address><sup>1</sup>Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK</address></li><li class="aff"><a id="aff-2" name="aff-2"></a><address><sup>2</sup>Division of Respiratory Medicine, University of Nottingham, Nottingham, UK</address></li><li class="aff"><a id="aff-3" name="aff-3"></a><address><sup>3</sup>Centre for Health Economics, University of York, York, UK</address></li><li class="aff"><a id="aff-4" name="aff-4"></a><address><sup>4</sup>Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, University of London, London, UK</address></li><li class="aff"><a id="aff-5" name="aff-5"></a><address><sup>5</sup>Department of Statistics, Open University, Milton Keynes, UK</address></li></ol><ol class="corresp-list"><li class="corresp" id="corresp-1"><span class="corresp-label"></span>Correspondence to:<br/> Dr R Hubbard<br/> Clinical Sciences Building, City Hospital, Hucknall Road, Nottingham NG5 1PB, UK; <span class="em-link" title="Richard.Hubbard@Nottingham.ac.uk"><span class="em-addr">Richard.HubbardNottingham.ac.uk</span></span></li></ol></div></div></div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-highwire-markup abstract-with-bc" > <div class="pane-content"> <div class="highwire-markup"><div xmlns="http://www.w3.org/1999/xhtml" id="content-block" xmlns:xhtml="http://www.w3.org/1999/xhtml"><div class="article abstract-view"><span class="highwire-journal-article-marker-start"></span><div class="section abstract" id="abstract-1"><h2>Abstract</h2> <p id="p-1"><strong>Background:</strong> Bupropion is an effective smoking cessation therapy but its use in the UK has been limited by concerns that it may increase the risk of sudden death.</p> <p id="p-2"><strong>Methods:</strong> Data for all patients prescribed bupropion within The Health Improvement Network (a computerised general practice database) were extracted and the self-controlled case-series method was used to estimate the relative incidence of death during the first 28 days of treatment. The incidence of seizures, a recognised adverse effect of bupropion, was also investigated during this period.</p> <p id="p-3"><strong>Results:</strong> A total of 9329 individuals had been prescribed bupropion (mean age 44 years, 48% male). The total person-time after the first prescription for bupropion was 17 586 years, and during this time 121 people died. Two people died within the first 28 days of treatment, which was less than expected in comparison with the remaining observation period by an incidence ratio of 0.50 (95% confidence interval (CI) 0.12 to 2.05). Twenty eight people were recorded as having a total of 45 seizures (23 before starting bupropion, two in the first 28 days of treatment, and 20 at a later point). The relative incidence of seizures during the first 28 days of treatment was 3.62 (95% CI 0.87 to 15.09), equivalent to one additional seizure per 6219 first time bupropion users.</p> <p id="p-4"><strong>Conclusions:</strong> Bupropion use is probably associated with an increased risk of seizures, but no evidence was found to suggest that the drug is associated with an increased risk of sudden death.</p> </div><ul class="kwd-group KWD"><li class="kwd">bupropion</li><li class="kwd">smoking cessation</li><li class="kwd">seizures</li><li class="kwd">sudden death</li><li class="kwd">post-marketing surveillance</li></ul><span class="highwire-journal-article-marker-end"></span></div><span class="related-urls"></span></div></div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-dfp-pane oas-ads oas-ads-mid pull-right" > <div class="pane-content"> <div id="dfp-ad-mpu-wrapper" class="dfp-tag-wrapper"> <div id="dfp-ad-mpu" class="dfp-tag-wrapper"> <script type="text/javascript"> googletag.cmd.push(function() { googletag.display("dfp-ad-mpu"); }); </script> </div> </div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-custom pane-1" > <div class="pane-content"> <p><a href="https://doi.org/10.1136/thx.2005.041798" target="_new">https://doi.org/10.1136/thx.2005.041798</a></p> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-highwire-altmetrics" > <h2 class="pane-title">Statistics from Altmetric.com</h2> <div class="pane-content"> <div data-badge-details="right" data-badge-type="medium-donut" data-doi="10.1136/thx.2005.041798" data-hide-no-mentions="true" class="altmetric-embed"></div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-bmjj-jumplinks" > <div class="pane-content"> <div class="highwire-list-wrapper"><div class="highwire-list"><ul></ul></div></div> </div> </div> <div class="panel-separator"></div><div class="panel-pane pane-custom pane-2 permissions-box" > <h2 class="pane-title">Request Permissions</h2> <div class="pane-content"> <p>If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. 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JB has received an honorarium from a third party organisation but originating from GlaxoSmithKline (the producers of bupropion) for speaking at an invited conference on smoking cessation management guidelines in 2002, and also received consulting fees from the manufacturers of nicotine replacement therapy and other novel smoking cessation therapies.</p> </li><li class="fn" id="fn-4"> <p id="p-25">RH, JB and LS were responsible for the main study hypothesis and RH, SL, CS, CG, LS, PF and JB were responsible for the detailed study design and were applicants on the British Lung Foundation grant. The analysis was performed by RH, JW, SL, PF and CS. 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