Editing Paroxetine (section)

==Society and culture==

Paroxetine was approved for medical use in the United States in 1992 and initially sold by [[GlaxoSmithKline]].<ref name="AHFS2019" /><ref>{{cite book|url=https://books.google.com/books?id=JDZ4DAAAQBAJ&pg=PR344|title=Approved Drug Products with Therapeutic Equivalence Evaluations – FDA Orange Book 31st Edition (2011): FDA Orange Book 31st Edition (2011)|author=Food and Drug Administration|date=2011|publisher=DrugPatentWatch.com|isbn=9781934899816|page=344|access-date=4 March 2019|archive-url=https://web.archive.org/web/20190306043352/https://books.google.ca/books?id=JDZ4DAAAQBAJ&pg=PR344|archive-date=6 March 2019|url-status=live}}</ref> It is available as a [[generic medication]].<ref name="BNF76"/> In 2022, it was the 92nd most commonly prescribed medication in the United States, with more than 7{{nbsp}}million prescriptions.<ref name="ClinCalc Top 300" /><ref name="ClinCalc Paroxetine" /> It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].<ref name="WHO23rd" />

GlaxoSmithKline has paid substantial fines, paid settlements in [[Class action|class-action]] lawsuits, and become the subject of several highly critical books about its marketing of paroxetine, in particular, the [[off-label marketing]] of paroxetine for children, the suppression of negative research results relating to its use in children, and allegations that it failed to warn consumers of substantial withdrawal effects associated with the use of the drug.<ref name="JusticeDept2July2012" /><ref name="USvGSK26Oct2011" />

===Marketing===
{{See also|Study 329}}

In 2004, GSK agreed to settle charges of consumer fraud for $2.5 million.<ref>{{cite news |vauthors=Angell M |author-link=Marcia Angell |title=Drug Companies & Doctors: A Story of Corruption|newspaper=[[New York Review of Books]] |volume=56 |issue=1 |date=15 January 2009}}</ref> The [[legal discovery]] process also uncovered evidence of deliberate, systematic suppression of unfavorable Paxil research results. One of GSK's internal documents read, "It would be commercially unacceptable to include a statement that efficacy [in children] had not been demonstrated, as this would undermine the profile of paroxetine".<ref>{{cite journal | vauthors = Kondro W, Sibbald B | title = Drug company experts advised staff to withhold data about SSRI use in children | journal = CMAJ | volume = 170 | issue = 5 | pages = 783 | date = March 2004 | pmid = 14993169 | pmc = 343848 | doi = 10.1503/cmaj.1040213 }}</ref>

In 2012, the [[United States Department of Justice]] fined [[GlaxoSmithKline]] $3&nbsp;billion for withholding data, unlawfully promoting use in those under 18, and preparing an article that misleadingly reported the effects of paroxetine in adolescents with depression following its clinical trial [[study 329]].<ref name=JusticeDept2July2012>{{cite press release|url=https://www.justice.gov/opa/pr/2012/July/12-civ-842.html |title=GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data |publisher=[[United States Department of Justice]], Office of Public Affairs |date=2 July 2012 |quote=The United States alleges that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. |access-date=6 October 2015 |archive-url=https://web.archive.org/web/20140909141736/http://www.justice.gov/opa/pr/2012/July/12-civ-842.html |archive-date=9 September 2014 |url-status=live}}</ref><ref name=USvGSK26Oct2011>{{cite court |url= https://www.justice.gov/sites/default/files/opa/legacy/2012/07/02/us-complaint.pdf |archive-url=https://web.archive.org/web/20141019043414/http://www.justice.gov/sites/default/files/opa/legacy/2012/07/02/us-complaint.pdf |archive-date=19 October 2014 |url-status=live |litigants= United States ''ex rel.'' Greg Thorpe, et al. v. GlaxoSmithKline PLC, and GlaxoSmithKline LLC |court=[[United States District Court for the District of Massachusetts|D. Mass.]] |date=26 October 2011 |pinpoint=pp.&nbsp;3–19}}</ref><ref name=ThomasNYT2July2012>{{cite news| vauthors = Thomas K, Schmidt MS |url= https://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html |title=Glaxo Agrees to Pay $3 Billion in Fraud Settlement |newspaper=The New York Times |date=2 July 2012 |access-date=28 February 2017 |archive-url=https://web.archive.org/web/20170302145001/http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html |archive-date=2 March 2017 |url-status=live}}</ref>

In February 2016, the UK [[Competition and Markets Authority]] imposed record fines of £45 million on companies that were found to have infringed [[European Union]] and UK Competition law by entering into agreements to delay the market entry of [[Generic drug|generic]] versions of the drug in the UK. [[GlaxoSmithKline]] received the bulk of the fines, being fined £37,600,757. Other companies that produce generics were issued fines which collectively total £7,384,146. UK public health services are likely to claim damages for being overcharged in the period where the generic versions of the drug were illegally blocked from the market, as the generics are over 70% less expensive. [[GlaxoSmithKline]] may also face actions from other generic manufacturers who incurred losses as a result of the anticompetitive conduct.<ref>{{cite web|url=https://www.gov.uk/government/news/cma-fines-pharma-companies-45-million |title=CMA fines pharma companies £45 million |access-date=15 July 2016 |archive-url=https://web.archive.org/web/20160713190228/https://www.gov.uk/government/news/cma-fines-pharma-companies-45-million |archive-date=13 July 2016 |url-status=live}}</ref> In April 2016, appeals were lodged with the [[Competition Appeal Tribunal]] by the companies which were fined.<ref>{{Cite web |url=http://www.catribunal.org.uk/files/1252_GlaxoSmithKline_Summary_180416.pdf |title=GlaxoSmithKline Summary |access-date=15 July 2016 |archive-url=https://web.archive.org/web/20161012181505/http://www.catribunal.org.uk/files/1252_GlaxoSmithKline_Summary_180416.pdf |archive-date=12 October 2016 |url-status=live}}</ref><ref>{{Cite web |url=http://www.catribunal.org.uk/files/1251_Generics_Summary_180416.pdf |title=Generics Summary |access-date=15 July 2016 |archive-url=https://web.archive.org/web/20161012181518/http://www.catribunal.org.uk/files/1251_Generics_Summary_180416.pdf |archive-date=12 October 2016 |url-status=live}}</ref><ref>{{Cite web |url=http://www.catribunal.org.uk/files/1253_Xellia_Summary_180416.pdf |title=Xellia Summary |access-date=15 July 2016 |archive-url=https://web.archive.org/web/20161012181340/http://www.catribunal.org.uk/files/1253_Xellia_Summary_180416.pdf |archive-date=12 October 2016 |url-status=live}}</ref><ref>{{Cite web |url=http://www.catribunal.org.uk/files/1255_Merck_Summary_180416.pdf |title=Merck Summary |access-date=15 July 2016 |archive-url=https://web.archive.org/web/20161012181540/http://www.catribunal.org.uk/files/1255_Merck_Summary_180416.pdf |archive-date=12 October 2016 |url-status=live}}</ref><ref>{{Cite web |url=http://www.catribunal.org.uk/files/1254_Actavis_Summary_180416.pdf |title=Actavis Summary |access-date=15 July 2016 |archive-url=https://web.archive.org/web/20161012181355/http://www.catribunal.org.uk/files/1254_Actavis_Summary_180416.pdf |archive-date=12 October 2016 |url-status=live}}</ref>

GSK marketed paroxetine through television advertisements in the 1990s and 2000s. Commercials also aired for the CR version of the drug beginning in 2003.<ref>{{Cite web|url=https://adland.tv/adnews/paxil-cr-nametag-2003-30-usa |title=Paxil CR -- Nametag -- (2003) :30 (USA) &#124; Adland |date=3 April 2004 |access-date=24 February 2020 |archive-url=https://web.archive.org/web/20200224054920/https://adland.tv/adnews/paxil-cr-nametag-2003-30-usa |archive-date=24 February 2020 |url-status=live}}</ref>

===Economics===
In 2007, paroxetine was ranked 94th on the [[list of bestselling drugs]], with over $1 billion in sales. In 2006, paroxetine was the fifth-most prescribed antidepressant in the U.S. retail market, with more than 19.7 million prescriptions.<ref>The paroxetine prescriptions were calculated as a total of prescriptions for Paxil CR and generic paroxetine using data from the charts for generic and brand-name drugs.{{cite web |title=Top 200 generic drugs by units in 2006. Top 200 brand-name drugs by units |website=Drug Topics, 5 March 2007 |url=http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=407652 |archive-url=https://archive.today/20130121183836/http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=407652 |url-status=dead |archive-date=21 January 2013 |access-date=8 April 2007 }}</ref> In 2007, sales had dropped slightly to 18.1 million but paroxetine remained the fifth-most prescribed antidepressant in the U.S.<ref>The paroxetine prescriptions were calculated as a total of prescriptions for Paxil CR and generic paroxetine using data from the charts for generic and brand-name drugs.{{cite web|title=Top 200 generic drugs by units in 2007 |website=Drug Topics |date=18 February 2008 |url=http://drugtopics.modernmedicine.com/drugtopics/Top200Drugs/ArticleStandard/article/detail/491194 |archive-url=https://web.archive.org/web/20090718184023/http://drugtopics.modernmedicine.com/drugtopics/Top200Drugs/ArticleStandard/article/detail/491194 |archive-date=18 July 2009 |access-date=23 October 2008}}</ref><ref>{{cite web |title=Top 200 brand drugs by units in 2007 |website=Drug Topics, 18 February 2008 |url=http://drugtopics.modernmedicine.com/drugtopics/PharmacyFactsAndFigures/ArticleStandard/article/detail/491210 |archive-url=https://web.archive.org/web/20090629042030/http://drugtopics.modernmedicine.com/drugtopics/PharmacyFactsAndFigures/ArticleStandard/article/detail/491210 |archive-date=29 June 2009 |access-date=23 October 2008}}</ref>

===Brand names===
Brand names include Aropax, Paretin, Brisdelle, Deroxat, Paxil,<ref name="Nevels2016">{{cite journal | vauthors = Nevels RM, Gontkovsky ST, Williams BE | title = Paroxetine-The Antidepressant from Hell? Probably Not, But Caution Required | journal = Psychopharmacology Bulletin | volume = 46 | issue = 1 | pages = 77–104 | date = March 2016 | pmid = 27738376 | pmc = 5044489 }}</ref><ref>{{cite book |title=Dictionary of Psychology |publisher=Oxford University Press | vauthors = Coleman A |year=2006 |pages=552 |edition=Second}}</ref> Pexeva, Paxtine, Paxetin, Paroxat, Paraxyl,<ref>{{cite book |title=Dictionary of Psychology |publisher=Oxford University Press | vauthors = Coleman A |year=2006 |pages=161 |edition=Second}}</ref> Sereupin, Daparox and Seroxat.