{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,9]],"date-time":"2026-11-09T20:22:28Z","timestamp":1794255748185,"version":"4.9.0"},"reference-count":52,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"DOI":"10.1001\/jamanetworkopen.2020.3630","type":"journal-article","created":{"date-parts":[[2020,4,28]],"date-time":"2020-04-28T15:32:38Z","timestamp":1588087958000},"page":"e203630","source":"Crossref","is-referenced-by-count":43,"title":["Association of the US Food and Drug Administration Antipsychotic Drug Boxed Warning With Medication Use and Health Outcomes in Elderly Patients With Dementia"],"prefix":"10.1001","volume":"3","author":[{"given":"Annalisa","family":"Rubino","sequence":"first","affiliation":[{"name":"Evidera, Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myrlene","family":"Sanon","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael L.","family":"Ganz","sequence":"additional","affiliation":[{"name":"Evidera, Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Simpson","sequence":"additional","affiliation":[{"name":"Evidera, Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miriam C.","family":"Fenton","sequence":"additional","affiliation":[{"name":"Evidera, Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumit","family":"Verma","sequence":"additional","affiliation":[{"name":"Evidera, Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann","family":"Hartry","sequence":"additional","affiliation":[{"name":"Lundbeck LLC, Deerfield, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ross A.","family":"Baker","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth A.","family":"Duffy","sequence":"additional","affiliation":[{"name":"Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keva","family":"Gwin","sequence":"additional","affiliation":[{"name":"Lundbeck LLC, Deerfield, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Howard","family":"Fillit","sequence":"additional","affiliation":[{"name":"Mount Sinai Medical Center, New York City, New York"},{"name":"Alzheimer\u2019s Drug Discovery Foundation, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2020,4,28]]},"reference":[{"key":"zoi200168r2","first-page":"125","article-title":"Clinical features and multidisciplinary approaches to dementia care.","volume":"4","author":"Grand","year":"2011","journal-title":"J Multidiscip Healthc"},{"issue":"4","key":"zoi200168r3","doi-asserted-by":"publisher","first-page":"298","DOI":"10.1007\/s11920-012-0288-5","article-title":"Behavioral disturbance in dementia.","volume":"14","author":"Desai","year":"2012","journal-title":"Curr Psychiatry Rep"},{"issue":"73","key":"zoi200168r4","first-page":"73","article-title":"Behavioral and psychological symptoms of dementia.","volume":"3","author":"Cerejeira","year":"2012","journal-title":"Front Neurol"},{"issue":"1","key":"zoi200168r5","doi-asserted-by":"crossref","first-page":"49","DOI":"10.31887\/DCNS.2003.5.1\/fmuellerspahn","article-title":"Behavioral disturbances in dementia.","volume":"5","author":"M\u00fcller-Spahn","year":"2003","journal-title":"Dialogues Clin Neurosci"},{"issue":"3","key":"zoi200168r6","doi-asserted-by":"publisher","first-page":"346","DOI":"10.1017\/S1041610209991505","article-title":"Management of behavioral problems in Alzheimer\u2019s disease.","volume":"22","author":"Gauthier","year":"2010","journal-title":"Int Psychogeriatr"},{"issue":"1","key":"zoi200168r7","doi-asserted-by":"publisher","first-page":"50","DOI":"10.1002\/(ISSN)1099-1166","article-title":"Dementia patients caregivers quality of life: the PIXEL study.","volume":"21","author":"Thomas","year":"2006","journal-title":"Int J Geriatr Psychiatry"},{"issue":"10","key":"zoi200168r8","doi-asserted-by":"publisher","first-page":"917","DOI":"10.1097\/JGP.0b013e3181d5745d","article-title":"Caregiver burden in Alzheimer disease: cross-sectional and longitudinal patient correlates.","volume":"18","author":"Mohamed","year":"2010","journal-title":"Am J Geriatr Psychiatry"},{"issue":"2","key":"zoi200168r9","doi-asserted-by":"publisher","first-page":"116","DOI":"10.1097\/WAD.0b013e318203f208","article-title":"Caregiver burden and neuropsychiatric symptoms in older adults with cognitive impairment: the Aging, Demographics, and Memory Study (ADAMS).","volume":"25","author":"Okura","year":"2011","journal-title":"Alzheimer Dis Assoc Disord"},{"issue":"16","key":"zoi200168r10","doi-asserted-by":"publisher","first-page":"2090","DOI":"10.1001\/jama.287.16.2090","article-title":"Patient and caregiver characteristics and nursing home placement in patients with dementia.","volume":"287","author":"Yaffe","year":"2002","journal-title":"JAMA"},{"issue":"2","key":"zoi200168r11","doi-asserted-by":"publisher","first-page":"191","DOI":"10.1097\/MLR.0b013e31818457ce","article-title":"Predictors of nursing home admission for persons with dementia.","volume":"47","author":"Gaugler","year":"2009","journal-title":"Med Care"},{"issue":"10","key":"zoi200168r12","doi-asserted-by":"publisher","first-page":"972","DOI":"10.1002\/(ISSN)1099-1166","article-title":"The contribution of neuropsychiatric symptoms to the cost of dementia care.","volume":"21","author":"Herrmann","year":"2006","journal-title":"Int J Geriatr Psychiatry"},{"issue":"11","key":"zoi200168r13","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2016-013591","article-title":"Predictors of care home and hospital admissions and their costs for older people with Alzheimer\u2019s disease: findings from a large London case register.","volume":"6","author":"Knapp","year":"2016","journal-title":"BMJ Open"},{"issue":"19","key":"zoi200168r14","doi-asserted-by":"publisher","first-page":"2020","DOI":"10.1001\/jama.2012.36918","article-title":"Nonpharmacologic management of behavioral symptoms in dementia.","volume":"308","author":"Gitlin","year":"2012","journal-title":"JAMA"},{"issue":"5","key":"zoi200168r15","doi-asserted-by":"publisher","first-page":"543","DOI":"10.1176\/appi.ajp.2015.173501","article-title":"The American Psychiatric Association practice guideline on the use of antipsychotics to treat agitation or psychosis in patients with dementia.","volume":"173","author":"Reus","year":"2016","journal-title":"Am J Psychiatry"},{"issue":"15","key":"zoi200168r16","doi-asserted-by":"publisher","first-page":"1934","DOI":"10.1001\/jama.294.15.1934","article-title":"Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials.","volume":"294","author":"Schneider","year":"2005","journal-title":"JAMA"},{"issue":"11","key":"zoi200168r17","first-page":"1269","article-title":"Risperidone (Risperdal): increased rate of cerebrovascular events in dementia trials.","volume":"167","author":"Wooltorton","year":"2002","journal-title":"CMAJ"},{"issue":"9","key":"zoi200168r18","doi-asserted-by":"publisher","first-page":"1395","DOI":"10.1503\/cmaj.1040539","article-title":"Olanzapine (Zyprexa): increased incidence of cerebrovascular events in dementia trials.","volume":"170","author":"Wooltorton","year":"2004","journal-title":"CMAJ"},{"issue":"11","key":"zoi200168r22","doi-asserted-by":"publisher","first-page":"775","DOI":"10.7326\/0003-4819-146-11-200706050-00006","article-title":"Antipsychotic drug use and mortality in older adults with dementia.","volume":"146","author":"Gill","year":"2007","journal-title":"Ann Intern Med"},{"issue":"5","key":"zoi200168r23","doi-asserted-by":"publisher","first-page":"627","DOI":"10.1503\/cmaj.061250","article-title":"Risk of death associated with the use of conventional versus atypical antipsychotic drugs among elderly patients.","volume":"176","author":"Schneeweiss","year":"2007","journal-title":"CMAJ"},{"issue":"2","key":"zoi200168r24","doi-asserted-by":"publisher","first-page":"346","DOI":"10.1093\/pubmed\/fdu023","article-title":"Second-generation antipsychotic drug use in hospital inpatients with dementia: the impact of a safety warning on rates of prescribing.","volume":"37","author":"McIlroy","year":"2015","journal-title":"J Public Health (Oxf)"},{"issue":"2","key":"zoi200168r25","doi-asserted-by":"publisher","first-page":"190","DOI":"10.1001\/archgenpsychiatry.2010.200","article-title":"Trends in antipsychotic use in dementia 1999-2007.","volume":"68","author":"Kales","year":"2011","journal-title":"Arch Gen Psychiatry"},{"issue":"1","key":"zoi200168r26","doi-asserted-by":"publisher","first-page":"95","DOI":"10.1016\/j.euroneuro.2013.09.003","article-title":"Trends in use of antipsychotics in elderly patients with dementia: Impact of national safety warnings.","volume":"24","author":"Gallini","year":"2014","journal-title":"Eur Neuropsychopharmacol"},{"issue":"5","key":"zoi200168r27","doi-asserted-by":"publisher","first-page":"453","DOI":"10.1016\/j.jalz.2011.08.004","article-title":"Impact of the Food and Drug Administration\u2019s antipsychotic black box warning on psychotropic drug prescribing in elderly patients with dementia in outpatient and office-based settings.","volume":"8","author":"Desai","year":"2012","journal-title":"Alzheimers Dement"},{"issue":"1","key":"zoi200168r28","doi-asserted-by":"publisher","first-page":"96","DOI":"10.1001\/archinternmed.2009.456","article-title":"Impact of FDA black box advisory on antipsychotic medication use.","volume":"170","author":"Dorsey","year":"2010","journal-title":"Arch Intern Med"},{"issue":"3","key":"zoi200168r32","doi-asserted-by":"publisher","first-page":"220","DOI":"10.1097\/00005650-199603000-00003","article-title":"A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity.","volume":"34","author":"Ware","year":"1996","journal-title":"Med Care"},{"issue":"5","key":"zoi200168r35","doi-asserted-by":"publisher","first-page":"495","DOI":"10.1177\/0897190015579451","article-title":"Impact of FDA black box warning on psychotropic drug use in noninstitutionalized elderly patients diagnosed with dementia: a retrospective study.","volume":"29","author":"Singh","year":"2016","journal-title":"J Pharm Pract"},{"issue":"4","key":"zoi200168r36","doi-asserted-by":"publisher","first-page":"615","DOI":"10.1016\/j.ahj.2003.10.039","article-title":"Clinically important differences in health status for patients with heart disease: an expert consensus panel report.","volume":"147","author":"Wyrwich","year":"2004","journal-title":"Am Heart J"},{"issue":"9","key":"zoi200168r38","doi-asserted-by":"publisher","first-page":"1032","DOI":"10.1111\/apt.2009.29.issue-9","article-title":"Evaluation of the meaningfulness of health-related quality of life improvements as assessed by the SF-36 and the EQ-5D VAS in patients with active Crohn\u2019s disease.","volume":"29","author":"Coteur","year":"2009","journal-title":"Aliment Pharmacol Ther"},{"key":"zoi200168r39","doi-asserted-by":"publisher","first-page":"k2833","DOI":"10.1136\/bmj.k2833","article-title":"Trends in opioid use in commercially insured and Medicare Advantage populations in 2007-16: retrospective cohort study.","volume":"362","author":"Jeffery","year":"2018","journal-title":"BMJ"},{"issue":"6","key":"zoi200168r40","doi-asserted-by":"publisher","first-page":"511","DOI":"10.1080\/14740338.2019.1614166","article-title":"Analgesic treatments in people with dementia\u2014how safe are they? a systematic review.","volume":"18","author":"Erdal","year":"2019","journal-title":"Expert Opin Drug Saf"},{"issue":"7","key":"zoi200168r41","doi-asserted-by":"publisher","first-page":"708","DOI":"10.1016\/j.jagp.2012.12.006","article-title":"The response of agitated behavior to pain management in persons with dementia.","volume":"22","author":"Husebo","year":"2014","journal-title":"Am J Geriatr Psychiatry"},{"issue":"4","key":"zoi200168r42","doi-asserted-by":"publisher","first-page":"675","DOI":"10.1097\/j.pain.0000000000000095","article-title":"Pain, agitation, and behavioural problems in people with dementia admitted to general hospital wards: a longitudinal cohort study.","volume":"156","author":"Sampson","year":"2015","journal-title":"Pain"},{"issue":"1","key":"zoi200168r43","doi-asserted-by":"publisher","first-page":"75","DOI":"10.1016\/j.nurt.2006.10.003","article-title":"Use of antiepileptic drugs for nonepileptic conditions: psychiatric disorders and chronic pain.","volume":"4","author":"Ettinger","year":"2007","journal-title":"Neurotherapeutics"},{"issue":"15","key":"zoi200168r44","doi-asserted-by":"publisher","first-page":"1747","DOI":"10.1007\/s40265-014-0293-6","article-title":"Antiepileptic drugs for the treatment of agitation and aggression in dementia: do they have a place in therapy?","volume":"74","author":"Gallagher","year":"2014","journal-title":"Drugs"},{"issue":"4","key":"zoi200168r45","doi-asserted-by":"publisher","first-page":"273","DOI":"10.2165\/11319120-000000000-00000","article-title":"Cerebrovascular accidents in elderly people treated with antipsychotic drugs: a systematic review.","volume":"33","author":"Sacchetti","year":"2010","journal-title":"Drug Saf"},{"issue":"7","key":"zoi200168r46","doi-asserted-by":"publisher","first-page":"1182","DOI":"10.1111\/jgs.2011.59.issue-7","article-title":"Risk of cerebrovascular accident associated with use of antipsychotics: population-based case-control study.","volume":"59","author":"Laredo","year":"2011","journal-title":"J Am Geriatr Soc"},{"key":"zoi200168r47","first-page":"2828","article-title":"Methodological comparison of estimates of ambulatory health care use from the Medical Expenditure Panel Survey and other data sources.","volume":"292","author":"Rhoades","year":"2010","journal-title":"Proceedings of the Joint Statistical Meetings"},{"issue":"12","key":"zoi200168r48","doi-asserted-by":"publisher","first-page":"966","DOI":"10.1161\/CIRCULATIONAHA.113.007787","article-title":"Trends in hospitalizations and outcomes for acute cardiovascular disease and stroke, 1999-2011.","volume":"130","author":"Krumholz","year":"2014","journal-title":"Circulation"},{"issue":"21","key":"zoi200168r49","doi-asserted-by":"publisher","first-page":"1952","DOI":"10.1001\/archinternmed.2009.357","article-title":"Meta-analysis of the impact of 9 medication classes on falls in elderly persons.","volume":"169","author":"Woolcott","year":"2009","journal-title":"Arch Intern Med"},{"issue":"18","key":"zoi200168r50","doi-asserted-by":"publisher","first-page":"509","DOI":"10.15585\/mmwr.mm6718a1","article-title":"Deaths from falls among persons aged =65 years\u2014United States, 2007\u20132016.","volume":"67","author":"Burns","year":"2018","journal-title":"MMWR Morb Mortal Wkly Rep"},{"issue":"1","key":"zoi200168r51","first-page":"348","article-title":"Interrupted time series regression for the evaluation of public health interventions: a tutorial.","volume":"46","author":"Bernal","year":"2017","journal-title":"Int J Epidemiol"},{"key":"zoi200168r52","doi-asserted-by":"publisher","first-page":"h2750","DOI":"10.1136\/bmj.h2750","article-title":"Regression based quasi-experimental approach when randomisation is not an option: interrupted time series analysis.","volume":"350","author":"Kontopantelis","year":"2015","journal-title":"BMJ"},{"key":"zoi200168r37","volume-title":"User\u2019s Manual for the SF-36 V2 Health Survey","author":"Ware","year":"2007","edition":"2nd ed"},{"key":"zoi200168r1","unstructured":"Alzheimer\u2019s Association. 2018 Alzheimer\u2019s disease facts and figures. Accessed September 1, 2018. https:\/\/www.alz.org\/media\/HomeOffice\/Facts and Figures\/facts-and-figures.pdf"},{"key":"zoi200168r19","unstructured":"Medicines and Healthcare Products Regulatory Agency. New advice issued on risperidone and olanzapine [press release]. Accessed October 11, 2018. https:\/\/webarchive.nationalarchives.gov.uk\/20140208042659\/http:\/\/www.mhra.gov.uk\/PrintPreview\/PressReleaseSP\/CON002047"},{"key":"zoi200168r20","unstructured":"US Food and Drug Administration. Public health advisory: deaths with antipsychotics in elderly patients with behavioral disturbances. Accessed August 22, 2018. https:\/\/wayback.archive-it.org\/7993\/20170113112252\/http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm053171.htm"},{"key":"zoi200168r21","unstructured":"US Food and Drug Administration. Information for healthcare professionals: conventional antipsychotics. Accessed October 10, 2018. https:\/\/wayback.archive-it.org\/7993\/20170722190727\/https:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm124830.htm"},{"key":"zoi200168r29","unstructured":"Agency for Healthcare Research and Quality (AHRQ). Medical Expenditure Panel Survey data release schedule. Accessed November 28, 2018. https:\/\/meps.ahrq.gov\/about_meps\/releaseschedule.jsp"},{"key":"zoi200168r30","unstructured":"National Center for Health Statistics. Ambulatory health care data. Accessed August 23, 2018. https:\/\/www.cdc.gov\/nchs\/ahcd\/index.htm"},{"key":"zoi200168r31","unstructured":"Agency for Healthcare Research and Quality (AHRQ). Medical Expenditure Panel Survey. Accessed August 23, 2018. https:\/\/meps.ahrq.gov\/mepsweb\/about_meps\/survey_back.jsp"},{"key":"zoi200168r33","unstructured":"Centers for Disease Control and Prevention. Ambulatory health care data: scope and sample design. Published November 6, 2015. Accessed April 3, 2019. https:\/\/www.cdc.gov\/nchs\/ahcd\/ahcd_scope.htm"},{"key":"zoi200168r34","unstructured":"Chowdhury? S, Machlin? S. Variance estimation from MEPS event files, methodology report No. 26. Agency for Healthcare Research and Quality; September 2011. Accessed October 12, 2018. https:\/\/meps.ahrq.gov\/data_files\/publications\/mr26\/mr26.shtml"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2765053\/rubino_2020_oi_200168.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,3,11]],"date-time":"2021-03-11T17:33:49Z","timestamp":1615484029000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2765053"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,4,28]]},"references-count":52,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2020,4,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2020.3630","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,4,28]]}}}