{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T17:01:03Z","timestamp":1790096463690,"version":"4.0.1"},"reference-count":55,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"funder":[{"DOI":"10.13039\/501100003407","name":"Ministero dell\u2019Istruzione, dell\u2019Universit\u00e0 e della Ricerca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003407","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Pharmacological Research"],"published-print":{"date-parts":[[2021,1]]},"DOI":"10.1016\/j.phrs.2020.105229","type":"journal-article","created":{"date-parts":[[2020,10,5]],"date-time":"2020-10-05T01:39:37Z","timestamp":1601861977000},"page":"105229","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":5,"special_numbering":"C","title":["Misleading meta-analyses of observational studies may generate unjustified alarms: The case of medications for nausea and vomiting in pregnancy"],"prefix":"10.1016","volume":"163","author":[{"given":"Annalisa","family":"Biffi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico","family":"Rea","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Locatelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Cetin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amelia","family":"Filippelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Corrao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.phrs.2020.105229_bib0005","doi-asserted-by":"crossref","first-page":"1355","DOI":"10.1111\/j.1360-0443.2011.03440.x","article-title":"Randomized controlled trials in pregnancy: scientific and ethical aspects exposure to different opioid medications during pregnancy in an intra-individual comparison","volume":"106","author":"Unger","year":"2011","journal-title":"Addiction"},{"key":"10.1016\/j.phrs.2020.105229_bib0010","doi-asserted-by":"crossref","first-page":"901","DOI":"10.1016\/j.ajog.2005.06.020","article-title":"A comprehensive ethical framework for responsibly designing and conducting pharmacologic research that involves pregnant women","volume":"193","author":"McCullough","year":"2005","journal-title":"Am. J. Obstet. Gynecol."},{"key":"10.1016\/j.phrs.2020.105229_bib0015","doi-asserted-by":"crossref","first-page":"280","DOI":"10.1016\/j.reprotox.2012.01.006","article-title":"Investigating outcomes associated with medication use during pregnancy: a review of methodological challenges and observational study designs","volume":"33","author":"Grzeskowiak","year":"2012","journal-title":"Reprod. Toxicol."},{"key":"10.1016\/j.phrs.2020.105229_bib0020","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1002\/sim.7969","article-title":"A Bayesian approach for correcting exposure misclassification in meta-analysis","volume":"38","author":"Lian","year":"2019","journal-title":"Stat. Med."},{"key":"10.1016\/j.phrs.2020.105229_bib0025","doi-asserted-by":"crossref","first-page":"337","DOI":"10.1016\/0890-6238(95)00020-B","article-title":"Bendectin: review of the medical literature of a comprehensively studied human nonteratogen and the most prevalent tortogen-litigen","volume":"9","author":"Brent","year":"1995","journal-title":"Reprod. Toxicol."},{"key":"10.1016\/j.phrs.2020.105229_bib0030","first-page":"545","article-title":"Congenital malformation surveillance bulletin","volume":"48","year":"1993","journal-title":"Teratology"},{"key":"10.1016\/j.phrs.2020.105229_bib0035","first-page":"66","article-title":"Measuring drug effectiveness by default: the case of Bendectin","volume":"86","author":"Neutel","year":"1995","journal-title":"Can. J. Public Health"},{"key":"10.1016\/j.phrs.2020.105229_bib0040","doi-asserted-by":"crossref","first-page":"161","DOI":"10.1159\/000477853","article-title":"Hyperemesis gravidarum: a review of recent literature","volume":"100","author":"London","year":"2017","journal-title":"Pharmacology"},{"key":"10.1016\/j.phrs.2020.105229_bib0045","first-page":"817","article-title":"The management of nausea and vomiting in pregnancy (Society of Obstetricians and Gynaecologists Canada: clinical Practice Guidelines, no. 120)","volume":"24","author":"Arsenault","year":"2002","journal-title":"J. Obstet. Gynaecol. Can."},{"key":"10.1016\/j.phrs.2020.105229_bib0050","series-title":"Nausea and Vomiting of Pregnancy. APGO Educational Series on Women\u2019s Health Issues","author":"APGO","year":"2013"},{"key":"10.1016\/j.phrs.2020.105229_bib0055","unstructured":"MothertoBaby. Nausea and vomiting. In: Maternal medical conditions fact sheets. Available at: https:\/\/mothertobaby.org\/fact-sheets\/nausea-vomiting-pregnancy-nvp\/pdf\/."},{"key":"10.1016\/j.phrs.2020.105229_bib0060","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1016\/j.jclinepi.2019.07.014","article-title":"New evidence for concern over the risk of birth defects from medications for nausea and vomitting of pregnancy","volume":"116","author":"B\u00e9rard","year":"2019","journal-title":"J. Clin. Epidemiol."},{"issue":"15","key":"10.1016\/j.phrs.2020.105229_bib0065","doi-asserted-by":"crossref","first-page":"2008","DOI":"10.1001\/jama.283.15.2008","article-title":"Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of Observational Studies in Epidemiology (MOOSE) group","volume":"283","author":"Stroup","year":"2000","journal-title":"JAMA"},{"issue":"1","key":"10.1016\/j.phrs.2020.105229_bib0070","doi-asserted-by":"crossref","first-page":"159","DOI":"10.2307\/2529310","article-title":"The measurement of observer agreement for categorical data","volume":"33","author":"Landis","year":"1977","journal-title":"Biometrics"},{"key":"10.1016\/j.phrs.2020.105229_bib0075","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1002\/bdra.22865","article-title":"Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects","volume":"94","author":"Anderka","year":"2012","journal-title":"Birth Defects Res. A Clin. Mol. Teratol."},{"key":"10.1016\/j.phrs.2020.105229_bib0080","doi-asserted-by":"crossref","first-page":"717","DOI":"10.1093\/oxfordjournals.aje.a009880","article-title":"Nausea during pregnancy and congenital heart defects: a population-based case-control study","volume":"149","author":"Boneva","year":"1999","journal-title":"Am. J. Epidemiol."},{"key":"10.1016\/j.phrs.2020.105229_bib0085","doi-asserted-by":"crossref","first-page":"151","DOI":"10.1002\/tera.1420400208","article-title":"Bendectin and human congenital malformations","volume":"40","author":"Shiono","year":"1989","journal-title":"Teratology"},{"key":"10.1016\/j.phrs.2020.105229_bib0090","doi-asserted-by":"crossref","first-page":"347","DOI":"10.1056\/NEJM198508083130603","article-title":"Congenital heart disease in relation to maternal use of Bendectin and other drugs in early pregnancy","volume":"313","author":"Zierler","year":"1985","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.phrs.2020.105229_bib0095","first-page":"451","article-title":"First-trimester drug use and congenital disorders","volume":"65","author":"Aselton","year":"1985","journal-title":"Obstet. Gynecol."},{"key":"10.1016\/j.phrs.2020.105229_bib0100","doi-asserted-by":"crossref","first-page":"1052","DOI":"10.1136\/adc.59.11.1052","article-title":"Maternal drug histories and central nervous system anomalies","volume":"59","author":"Winship","year":"1984","journal-title":"Arch. Dis. Child."},{"key":"10.1016\/j.phrs.2020.105229_bib0105","doi-asserted-by":"crossref","first-page":"559","DOI":"10.1093\/oxfordjournals.aje.a113917","article-title":"Investigation of a cluster of anencephaly and spina bifida","volume":"120","author":"Hearey","year":"1984","journal-title":"Am. J. Epidemiol."},{"key":"10.1016\/j.phrs.2020.105229_bib0110","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1002\/tera.1420270109","article-title":"Prospective study of suspected associations between certain drugs administered during early pregnancy and congenital malformations","volume":"27","author":"Michaelis","year":"1983","journal-title":"Teratology"},{"key":"10.1016\/j.phrs.2020.105229_bib0115","doi-asserted-by":"crossref","first-page":"919","DOI":"10.1016\/0002-9378(82)90185-5","article-title":"Bendectin (Debendox) as a risk factor for pyloric stenosis","volume":"144","author":"Eskenazi","year":"1982","journal-title":"Am. J. Obstet. Gynecol."},{"key":"10.1016\/j.phrs.2020.105229_bib0120","doi-asserted-by":"crossref","first-page":"343","DOI":"10.1001\/jama.1981.03320040015021","article-title":"First-trimester drug use and congenital disorders","volume":"246","author":"Jick","year":"1981","journal-title":"JAMA"},{"key":"10.1016\/j.phrs.2020.105229_bib0125","doi-asserted-by":"crossref","first-page":"410","DOI":"10.5694\/j.1326-5377.1981.tb135682.x","article-title":"Congenital anomalies in relation to the use of doxylamine\/dicyclomine and other antenatal factors: an ongoing prospective study","volume":"1","author":"Gibson","year":"1981","journal-title":"Med. J. Aust."},{"key":"10.1016\/j.phrs.2020.105229_bib0130","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1136\/bmj.283.6284.99","article-title":"Debendox in early pregnancy and fetal malformation","volume":"283","author":"Fleming","year":"1981","journal-title":"Br. Med. J. (Clin. Res. Ed.)"},{"key":"10.1016\/j.phrs.2020.105229_bib0135","first-page":"4143","article-title":"Legal testimony: David Mekdeci v. Merrell National Laboratories; United States District Court, Middle District of Florida","author":"Heinonen","year":"1980","journal-title":"Transcripts Proc."},{"key":"10.1016\/j.phrs.2020.105229_bib0140","doi-asserted-by":"crossref","first-page":"433","DOI":"10.1093\/oxfordjournals.aje.a112701","article-title":"Exogenous hormones and other drug exposures of children with congenital heart disease","volume":"109","author":"Rothman","year":"1979","journal-title":"Am. J. Epidemiol."},{"key":"10.1016\/j.phrs.2020.105229_bib0145","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1002\/tera.1420170109","article-title":"Teratogenicity testing in humans: a method demonstrating safety of bendectin","volume":"17","author":"Smithells","year":"1978","journal-title":"Teratology"},{"key":"10.1016\/j.phrs.2020.105229_bib0150","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1111\/j.1479-828X.1977.tb02610.x","article-title":"A survey of congenital abnormalities and drugs in a private practice","volume":"17","author":"Newman","year":"1977","journal-title":"N.Z.J. Obstet. Gynaecol."},{"key":"10.1016\/j.phrs.2020.105229_bib0155","doi-asserted-by":"crossref","first-page":"244","DOI":"10.1016\/0002-9378(76)90601-3","article-title":"An evaluation of the teratogenicity of certain antinauseant drugs","volume":"125","author":"Milkovich","year":"1976","journal-title":"Am. J. Obstet. Gynecol."},{"key":"10.1016\/j.phrs.2020.105229_bib0160","first-page":"775","article-title":"Drugs in pregnancy survey","volume":"191","author":"Russell","year":"1963","journal-title":"Practitioner"},{"key":"10.1016\/j.phrs.2020.105229_bib0165","first-page":"245","article-title":"A technique for controlled survey of case records","volume":"5","author":"Bunde","year":"1963","journal-title":"Curr. Ther. Res. Clin. Exp."},{"key":"10.1016\/j.phrs.2020.105229_bib0170","doi-asserted-by":"crossref","first-page":"101","DOI":"10.2307\/3001666","article-title":"The combination of estimates from different experiments","volume":"10","author":"Cochran","year":"1954","journal-title":"Biometrics"},{"key":"10.1016\/j.phrs.2020.105229_bib0175","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1136\/bmj.327.7414.557","article-title":"Measuring inconsistency in meta-analyses","volume":"327","author":"Higgins","year":"2003","journal-title":"BMJ"},{"key":"10.1016\/j.phrs.2020.105229_bib0180","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1016\/0197-2456(86)90046-2","article-title":"Meta-analysis in clinical trials","volume":"7","author":"DerSimonian","year":"1986","journal-title":"Control. Clin. Trials"},{"key":"10.1016\/j.phrs.2020.105229_bib0185","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1136\/bmj.315.7109.629","article-title":"Bias in meta-analysis detected by a simple, graphical test","volume":"315","author":"Egger","year":"1997","journal-title":"BMJ"},{"issue":"9","key":"10.1016\/j.phrs.2020.105229_bib0190","doi-asserted-by":"crossref","first-page":"603","DOI":"10.1007\/s10654-010-9491-z","article-title":"Critical evaluation of the Newcastle-Ottawa scale for the assessment of the quality of nonrandomized studies in meta-analyses","volume":"25","author":"Stang","year":"2010","journal-title":"Eur. J. Epidemiol."},{"issue":"4","key":"10.1016\/j.phrs.2020.105229_bib0195","doi-asserted-by":"crossref","first-page":"383","DOI":"10.1016\/j.jclinepi.2010.04.026","article-title":"GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables","volume":"64","author":"Guyatt","year":"2011","journal-title":"J. Clin. Epidemiol."},{"key":"10.1016\/j.phrs.2020.105229_bib0200","first-page":"269","article-title":"Choices, persistence and adherence to antihypertensive agents: evidence from RAMQ data","volume":"24","author":"Lachaine","year":"2008","journal-title":"Can. J. Cardiol."},{"key":"10.1016\/j.phrs.2020.105229_bib0205","doi-asserted-by":"crossref","DOI":"10.1002\/bdra.23604","article-title":"Can we rely on pharmacy claims databases to ascertain maternal use of medications during pregnancy?","volume":"109","author":"Zhao","year":"2017","journal-title":"Birth Defects Res."},{"key":"10.1016\/j.phrs.2020.105229_bib0210","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1097\/00001648-200109000-00006","article-title":"Do pregnant women report use of dispensed medications?","volume":"12","author":"Olesen","year":"2001","journal-title":"Epidemiology"},{"key":"10.1016\/j.phrs.2020.105229_bib0215","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0046626","article-title":"Methodological approaches to evaluate teratogenic risk using birth defect registries: advantages and disadvantages","volume":"7","author":"Poletta","year":"2012","journal-title":"PLoS One"},{"key":"10.1016\/j.phrs.2020.105229_bib0220","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1007\/s00228-009-0744-2","article-title":"Perception of risk regarding the use of medications and other exposures during pregnancy","volume":"66","author":"Nordeng","year":"2010","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"10.1016\/j.phrs.2020.105229_bib0225","doi-asserted-by":"crossref","first-page":"313","DOI":"10.1016\/S0890-6238(99)00018-0","article-title":"The perception of teratogenic risk by women with nausea and vomiting of pregnancy","volume":"13","author":"Mazzotta","year":"1999","journal-title":"Reprod. Toxicol."},{"key":"10.1016\/j.phrs.2020.105229_bib0230","doi-asserted-by":"crossref","first-page":"1370","DOI":"10.1093\/ije\/dyi184","article-title":"A method to automate probabilistic sensitivity analyses of misclassified binary variables","volume":"34","author":"Fox","year":"2005","journal-title":"Int. J. Epidemiol."},{"key":"10.1016\/j.phrs.2020.105229_bib0235","doi-asserted-by":"crossref","first-page":"1107","DOI":"10.1093\/ije\/25.6.1107","article-title":"Basic methods for sensitivity analysis of biases","volume":"25","author":"Greenland","year":"1996","journal-title":"Int. J. Epidemiol."},{"key":"10.1016\/j.phrs.2020.105229_bib0240","doi-asserted-by":"crossref","first-page":"881","DOI":"10.1002\/pds.3446","article-title":"Validity of congenital malformation diagnostic codes recorded in Quebec\u2019s administrative databases","volume":"22","author":"Blais","year":"2013","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"10.1016\/j.phrs.2020.105229_bib0245","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1055\/s-2007-994110","article-title":"Pregnancy outcome following first trimester exposure to antihistamines: meta-analysis","volume":"14","author":"Seto","year":"1997","journal-title":"Am. J. Perinatol."},{"key":"10.1016\/j.phrs.2020.105229_bib0250","series-title":"The Pharmacological Basis of Therapeutics","first-page":"586","article-title":"H1-receptor antagonists","author":"Serafin","year":"1996"},{"key":"10.1016\/j.phrs.2020.105229_bib0255","series-title":"Poisoning & Drug Overdose","first-page":"78","article-title":"Antihistamines","author":"Tani","year":"1998"},{"key":"10.1016\/j.phrs.2020.105229_bib0260","doi-asserted-by":"crossref","first-page":"1379","DOI":"10.1136\/bmj.281.6252.1379","article-title":"Debendox and congenital malformations in Northern Ireland","volume":"218","author":"Harron","year":"1980","journal-title":"Br. Med. J."},{"key":"10.1016\/j.phrs.2020.105229_bib0265","series-title":"Eurocat Data: Prevalence Charts and Tables","year":"2019"},{"key":"10.1016\/j.phrs.2020.105229_bib0270","first-page":"83","article-title":"Method of evaluating alleged human teratogens (editorial)","volume":"17","author":"Brent","year":"1978","journal-title":"Teratology"},{"key":"10.1016\/j.phrs.2020.105229_bib0275","doi-asserted-by":"crossref","first-page":"283","DOI":"10.1016\/S1470-2045(04)01466-4","article-title":"Use of chemotherapy during human pregnancy","volume":"5","author":"Cardonick","year":"2004","journal-title":"Lancet Oncol."}],"container-title":["Pharmacological Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1043661820315371?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1043661820315371?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T22:18:38Z","timestamp":1760912318000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1043661820315371"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1]]},"references-count":55,"alternative-id":["S1043661820315371"],"URL":"https:\/\/doi.org\/10.1016\/j.phrs.2020.105229","relation":{},"ISSN":["1043-6618"],"issn-type":[{"value":"1043-6618","type":"print"}],"subject":[],"published":{"date-parts":[[2021,1]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Misleading meta-analyses of observational studies may generate unjustified alarms: The case of medications for nausea and vomiting in pregnancy","name":"articletitle","label":"Article Title"},{"value":"Pharmacological Research","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.phrs.2020.105229","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2020 Elsevier Ltd. All rights reserved.","name":"copyright","label":"Copyright"}],"article-number":"105229"}}