Suicidal Behavior and Depression in Smoking Cessation Treatments
Publication Date
November 02, 2011
Journal
PLOS ONE
Authors
Thomas J. Moore, Curt D. Furberg, Joseph Glenmullen, John T. Maltsberger, et al
Volume
6
Issue
11
Pages
e27016
DOI
https://dx.plos.org/10.1371/journal.pone.0027016
Publisher URL
http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0027016
PubMed
http://www.ncbi.nlm.nih.gov/pubmed/22073240
PubMed Central
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3206890
Europe PMC
http://europepmc.org/abstract/MED/22073240
Web of Science
000297154900064
Scopus
80355136469
Mendeley
http://www.mendeley.com/research/suicidal-behavior-depression-smoking-cessation-treatments
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Mendeley | Further Information

{"title"=>"Suicidal behavior and depression in smoking cessation treatments", "type"=>"journal", "authors"=>[{"first_name"=>"Thomas J.", "last_name"=>"Moore", "scopus_author_id"=>"35464569200"}, {"first_name"=>"Curt D.", "last_name"=>"Furberg", "scopus_author_id"=>"7102960213"}, {"first_name"=>"Joseph", "last_name"=>"Glenmullen", "scopus_author_id"=>"36456929800"}, {"first_name"=>"John T.", "last_name"=>"Maltsberger", "scopus_author_id"=>"7006202058"}, {"first_name"=>"Sonal", "last_name"=>"Singh", "scopus_author_id"=>"8905235200"}], "year"=>2011, "source"=>"PLoS ONE", "identifiers"=>{"scopus"=>"2-s2.0-80355136469", "pmid"=>"22073240", "sgr"=>"80355136469", "doi"=>"10.1371/journal.pone.0027016", "isbn"=>"1932-6203", "issn"=>"19326203", "pui"=>"362861828"}, "id"=>"6efadb42-58ec-3636-82cb-ebe88e527730", "abstract"=>"BACKGROUND: Two treatments for smoking cessation--varenicline and bupropion--carry Boxed Warnings from the U.S. Food and Drug Administration (FDA) about suicidal/self-injurious behavior and depression. However, some epidemiological studies report an increased risk in smoking or smoking cessation independent of treatment, and differences between drugs are unknown.\\n\\nMETHODOLOGY: From the FDA's Adverse Event Reporting System (AERS) database from 1998 through September 2010 we selected domestic, serious case reports for varenicline (n = 9,575), bupropion for smoking cessation (n = 1,751), and nicotine replacement products (n = 1,917). A composite endpoint of suicidal/self-injurious behavior or depression was defined as a case with one or more Preferred Terms in Standardized MedDRA Query (SMQ) for those adverse effects. The main outcome measure was the ratio of reported suicide/self-injury or depression cases for each drug compared to all other serious events for that drug.\\n\\nRESULTS: Overall we identified 3,249 reported cases of suicidal/self-injurious behavior or depression, 2,925 (90%) for varenicline, 229 (7%) for bupropion, and 95 (3%) for nicotine replacement. Compared to nicotine replacement, the disproportionality results (OR (95% CI)) were varenicline 8.4 (6.8-10.4), and bupropion 2.9 (2.3-3.7). The disproportionality persisted after excluding reports indicating concomitant therapy with any of 58 drugs with suicidal behavior warnings or precautions in the prescribing information. An additional antibiotic comparison group showed that adverse event reports of suicidal/self-injurious behavior or depression were otherwise rare in a healthy population receiving short-term drug treatment.\\n\\nCONCLUSIONS: Varenicline shows a substantial, statistically significant increased risk of reported depression and suicidal/self-injurious behavior. Bupropion for smoking cessation had smaller increased risks. The findings for varenicline, combined with other problems with its safety profile, render it unsuitable for first-line use in smoking cessation.", "link"=>"http://www.mendeley.com/research/suicidal-behavior-depression-smoking-cessation-treatments", "reader_count"=>92, "reader_count_by_academic_status"=>{"Unspecified"=>4, "Professor > Associate Professor"=>4, "Librarian"=>2, "Researcher"=>24, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>7, "Other"=>9, "Student > Master"=>15, "Student > Bachelor"=>12, "Professor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>4, "Professor > Associate Professor"=>4, "Librarian"=>2, "Researcher"=>24, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>7, "Other"=>9, "Student > Master"=>15, "Student > Bachelor"=>12, "Professor"=>2}, "reader_count_by_subject_area"=>{"Unspecified"=>8, "Nursing and Health Professions"=>2, "Agricultural and Biological Sciences"=>6, "Medicine and Dentistry"=>49, "Neuroscience"=>2, "Arts and Humanities"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>5, "Psychology"=>11, "Chemistry"=>2, "Social Sciences"=>4, "Computer Science"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>49}, "Neuroscience"=>{"Neuroscience"=>2}, "Chemistry"=>{"Chemistry"=>2}, "Social Sciences"=>{"Social Sciences"=>4}, "Psychology"=>{"Psychology"=>11}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>6}, "Computer Science"=>{"Computer Science"=>2}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>2}, "Unspecified"=>{"Unspecified"=>8}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>5}, "Arts and Humanities"=>{"Arts and Humanities"=>1}}, "reader_count_by_country"=>{"Canada"=>1, "United States"=>3, "Japan"=>2, "Finland"=>1, "Brazil"=>1, "Denmark"=>1, "Australia"=>1}, "group_count"=>4}

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Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/363140"], "description"=>"<div><h3>Background</h3><p>Two treatments for smoking cessation—varenicline and bupropion—carry Boxed Warnings from the U.S. Food and Drug Administration (FDA) about suicidal/self-injurious behavior and depression. However, some epidemiological studies report an increased risk in smoking or smoking cessation independent of treatment, and differences between drugs are unknown.</p> <h3>Methodology</h3><p>From the FDA's Adverse Event Reporting System (AERS) database from 1998 through September 2010 we selected domestic, serious case reports for varenicline (n = 9,575), bupropion for smoking cessation (n = 1,751), and nicotine replacement products (n = 1,917). A composite endpoint of suicidal/self-injurious behavior or depression was defined as a case with one or more Preferred Terms in Standardized MedDRA Query (SMQ) for those adverse effects. The main outcome measure was the ratio of reported suicide/self-injury or depression cases for each drug compared to all other serious events for that drug.</p> <h3>Results</h3><p>Overall we identified 3,249 reported cases of suicidal/self-injurious behavior or depression, 2,925 (90%) for varenicline, 229 (7%) for bupropion, and 95 (3%) for nicotine replacement. Compared to nicotine replacement, the disproportionality results (OR (95% CI)) were varenicline 8.4 (6.8–10.4), and bupropion 2.9 (2.3–3.7). The disproportionality persisted after excluding reports indicating concomitant therapy with any of 58 drugs with suicidal behavior warnings or precautions in the prescribing information. An additional antibiotic comparison group showed that adverse event reports of suicidal/self-injurious behavior or depression were otherwise rare in a healthy population receiving short-term drug treatment.</p> <h3>Conclusions</h3><p>Varenicline shows a substantial, statistically significant increased risk of reported depression and suicidal/self-injurious behavior. Bupropion for smoking cessation had smaller increased risks. The findings for varenicline, combined with other problems with its safety profile, render it unsuitable for first-line use in smoking cessation.</p> </div>", "links"=>[], "tags"=>["suicidal", "smoking", "cessation", "treatments"], "article_id"=>131777, "categories"=>["Medicine", "Mental Health", "Biotechnology", "Pharmacology"], "users"=>["Thomas J. Moore", "Curt D. Furberg", "Joseph Glenmullen", "John T. Maltsberger", "Sonal Singh"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0027016"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Suicidal_Behavior_and_Depression_in_Smoking_Cessation_Treatments/131777", "title"=>"Suicidal Behavior and Depression in Smoking Cessation Treatments", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-11-02 00:29:37"}
  • {"files"=>["https://ndownloader.figshare.com/files/716783"], "description"=>"<p>Varenicline, bupriopion versus nicotine replacement.</p>", "links"=>[], "tags"=>["bupriopion", "nicotine"], "article_id"=>387141, "categories"=>["Medicine", "Mental Health", "Biotechnology", "Pharmacology"], "users"=>["Thomas J. Moore", "Curt D. Furberg", "Joseph Glenmullen", "John T. Maltsberger", "Sonal Singh"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0027016.g001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Varenicline_bupriopion_versus_nicotine_replacement_/387141", "title"=>"Varenicline, bupriopion versus nicotine replacement.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-11-02 01:59:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/716875"], "description"=>"<p>Varenicline, bupropion versus 3 antibiotics.</p>", "links"=>[], "tags"=>["bupropion"], "article_id"=>387239, "categories"=>["Medicine", "Mental Health", "Biotechnology", "Pharmacology"], "users"=>["Thomas J. Moore", "Curt D. Furberg", "Joseph Glenmullen", "John T. Maltsberger", "Sonal Singh"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0027016.g002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Varenicline_bupropion_versus_3_antibiotics_/387239", "title"=>"Varenicline, bupropion versus 3 antibiotics.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-11-02 02:00:39"}
  • {"files"=>["https://ndownloader.figshare.com/files/716941"], "description"=>"<p>*Totals do not add because more than 1 term could appear in a single case report.</p>", "links"=>[], "tags"=>["public health and epidemiology", "Mental health", "pharmacology", "Non-clinical medicine"], "article_id"=>387299, "categories"=>["Medicine", "Mental Health", "Biotechnology", "Pharmacology"], "users"=>["Thomas J. Moore", "Curt D. Furberg", "Joseph Glenmullen", "John T. Maltsberger", "Sonal Singh"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0027016.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_MedDRA_terms_in_suicidal_self_Injurious_behavior_and_depression_SMQs_/387299", "title"=>"MedDRA terms in suicidal/self-Injurious behavior and depression SMQs.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-11-02 02:01:39"}
  • {"files"=>["https://ndownloader.figshare.com/files/716976"], "description"=>"<p>Characteristics of Adverse Drug Event Reports.</p>", "links"=>[], "tags"=>["adverse"], "article_id"=>387334, "categories"=>["Medicine", "Mental Health", "Biotechnology", "Pharmacology"], "users"=>["Thomas J. Moore", "Curt D. Furberg", "Joseph Glenmullen", "John T. Maltsberger", "Sonal Singh"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0027016.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Characteristics_of_Adverse_Drug_Event_Reports_/387334", "title"=>"Characteristics of Adverse Drug Event Reports.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-11-02 02:02:14"}

PMC Usage Stats | Further Information

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Relative Metric

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