Editing Sertraline (section)

=== Suicide ===
The US [[Food and Drug Administration]] (FDA) requires all antidepressants, including sertraline, to carry a [[boxed warning]] stating that antidepressants increase the risk of suicide in persons younger than 25 years.<ref>{{cite journal | vauthors = Fornaro M, Anastasia A, Valchera A, Carano A, Orsolini L, Vellante F, Rapini G, Olivieri L, Di Natale S, Perna G, Martinotti G, Di Giannantonio M, De Berardis D | title = The FDA "Black Box" Warning on Antidepressant Suicide Risk in Young Adults: More Harm Than Benefits? | journal = Frontiers in Psychiatry | volume = 10 | issue = | pages = 294 | date = 2019 | pmid = 31130881 | pmc = 6510161 | doi = 10.3389/fpsyt.2019.00294 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Friedman RA | title = Antidepressants' black-box warning--10 years later | journal = The New England Journal of Medicine | volume = 371 | issue = 18 | pages = 1666–8 | date = October 2014 | pmid = 25354101 | doi = 10.1056/NEJMp1408480 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Stone MB | title = The FDA warning on antidepressants and suicidality--why the controversy? | journal = The New England Journal of Medicine | volume = 371 | issue = 18 | pages = 1668–71 | date = October 2014 | pmid = 25354102 | doi = 10.1056/NEJMp1411138 | doi-access = free }}</ref> This warning is based on statistical analyses conducted by two independent groups of FDA experts that found a 100% increase of suicidal thoughts and behavior in children and adolescents, and a 50% increase in the 18–24 age group.<ref name=FDA>{{cite web|vauthors=Levenson M, Holland C | title =Antidepressants and Suicidality in Adults: Statistical Evaluation. (Presentation at Psychopharmacologic Drugs Advisory Committee; December 13, 2006)|publisher = FDA|access-date = 11 July 2008|url = https://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4272s1-04-FDA.ppt}}</ref><ref name="FDA2">{{cite Q|Q118139691}}</ref><ref name="FDA3">{{cite Q|Q118139771}}</ref>

[[Suicidal ideation]] and behavior in clinical trials are rare. For the above analysis, the FDA combined the results of 295&nbsp;trials of 11&nbsp;antidepressants for psychiatric indications to obtain [[statistically significant]] results. Considered separately, sertraline use in adults decreased the odds of suicidal behavior with a marginal statistical significance of 37%<ref name =FDA3 /> or 50%<ref name =FDA2 /> depending on the statistical technique used. The authors of the FDA analysis note that "given the large number of comparisons made in this review, chance is a very plausible explanation for this difference".<ref name =FDA2 /> The more complete data submitted later by the sertraline manufacturer Pfizer indicated increased suicidal behavior.<ref>{{cite web |url=https://www.fda.gov/ohrms/dockets/dockets/06n0414/06N-0414-EC32-Attach-1.pdf |title=Memorandum from Pfizer Global Pharmaceuticals Re: DOCKET: 2006N-0414&nbsp;–"Suicidality data from adult antidepressant trials" Background package for December 13 Advisory Committee|access-date=11 July 2008 |author=Pfizer Inc. |date= 30 November 2006|work=FDA DOCKET 2006N-0414 |publisher=FDA}}</ref> Similarly, the analysis conducted by the UK [[Medicines and Healthcare products Regulatory Agency|MHRA]] found a 50% increase of odds of suicide-related events, not reaching statistical significance, in the patients on sertraline as compared to the ones on placebo.<ref>{{cite web|url=http://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con019472.pdf |title=Report of the CSM expert working group on the safety of selective serotonin reuptake inhibitor antidepressants|access-date=11 July 2008 |date=December 2004 |publisher=MHRA}}</ref><ref name="pmid15718537">{{cite journal | vauthors = Gunnell D, Saperia J, Ashby D | title = Selective serotonin reuptake inhibitors (SSRIs) and suicide in adults: meta-analysis of drug company data from placebo controlled, randomised controlled trials submitted to the MHRA's safety review | journal = BMJ | volume = 330 | issue = 7488 | pages = 385 | date = February 2005 | pmid = 15718537 | pmc = 549105 | doi = 10.1136/bmj.330.7488.385 }}</ref>