{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T10:40:53Z","timestamp":1790073653491,"version":"4.0.1"},"reference-count":20,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2023,3,25]],"date-time":"2023-03-25T00:00:00Z","timestamp":1679702400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,5,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Cytomegalovirus (CMV) is the leading cause of congenital infection worldwide. Reference anti-CMV treatment is valganciclovir\/ganciclovir, which is contraindicated in pregnancy given questions about teratogenicity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We analysed reports from VigiBase, the world\u2019s largest safety database, and performed a disproportionality analysis of adverse pregnancy outcomes associated with (val)ganciclovir compared with any other drugs or with (val)aciclovir as comparators.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 3\u200a104\u200a984 reports related to childbearing-age women or to pregnancy topics, 6186 were exposed to (val)ganciclovir or (val)aciclovir including 251 adverse pregnancy outcomes with (val)ganciclovir (n\u200a=\u200a34) or (val)aciclovir (n\u200a=\u200a217). We did not evidence any increased reporting of any adverse pregnancy outcome [miscarriage, stillbirth, small weight for gestational age, preterm birth (&amp;lt;37 weeks of gestation)] or birth defects with (val)ganciclovir compared with the use of (val)aciclovir during pregnancy. Four cases of oesophageal and anorectal atresia were identified with (val)ganciclovir, which may be related to concomitant drugs\/medical conditions and require further analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These preliminary results require confirmation but suggest the possibility for trial evaluation of val(ganciclovir) in severe maternal or fetal CMV infections.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jac\/dkad087","type":"journal-article","created":{"date-parts":[[2023,3,11]],"date-time":"2023-03-11T01:19:59Z","timestamp":1678497599000},"page":"1265-1269","source":"Crossref","is-referenced-by-count":27,"title":["Assessing the risk of adverse pregnancy outcomes and birth defects reporting in women exposed to ganciclovir or valganciclovir during pregnancy: a pharmacovigilance study"],"prefix":"10.1093","volume":"78","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2656-1423","authenticated-orcid":false,"given":"Adrien","family":"Contejean","sequence":"first","affiliation":[{"name":"Universit\u00e9 Paris Cit\u00e9, Paris, France"},{"name":"Infectious Diseases Department, Cochin Port Royal University Hospital, AP-HP Centre , 27 rue du Faubourg Saint Jacques, 75014 Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marianne","family":"Leruez-Ville","sequence":"additional","affiliation":[{"name":"Microbiology Unit, Necker-Enfants Malades University Hospital, AP-HP Centre , Paris , France"},{"name":"Universit\u00e9 Paris Cit\u00e9, Imagine, FETUS , F-75015 Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Marc","family":"Treluyer","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Paris Cit\u00e9, Paris, France"},{"name":"Regional Center of Pharmacovigilance, Pharmacology Department, Cochin Port Royal University Hospital, AP-HP Centre , Paris , France"},{"name":"Research Team EA7323 \u201cPharmacology and Therapeutic Assessment in Children and Pregnant Women\u201d, Universit\u00e9 Paris Cit\u00e9 , Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7650-6660","authenticated-orcid":false,"given":"Vassilis","family":"Tsatsaris","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Paris Cit\u00e9, Paris, France"},{"name":"Obstetrical Department, Cochin Port Royal University Hospital, AP-HP Centre , Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yves","family":"Ville","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Paris Cit\u00e9, Paris, France"},{"name":"Obstetrical Department, Necker Enfants Malades University Hospital, AP-HP Centre , Paris , France"},{"name":"Universit\u00e9 Paris Cit\u00e9, Imagine, FETUS , F-75015 Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9375-3620","authenticated-orcid":false,"given":"Caroline","family":"Charlier","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Paris Cit\u00e9, Paris, France"},{"name":"Infectious Diseases Department, Cochin Port Royal University Hospital, AP-HP Centre , 27 rue du Faubourg Saint Jacques, 75014 Paris , France"},{"name":"Institut Pasteur, French National Reference Center and WHO Collaborating Center Listeria , Paris , France"},{"name":"Institut Pasteur, Biology of Infection Unit , Inserm U1117, Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9626-3571","authenticated-orcid":false,"given":"Laurent","family":"Chouchana","sequence":"additional","affiliation":[{"name":"Regional Center of Pharmacovigilance, Pharmacology Department, Cochin Port Royal University Hospital, AP-HP Centre , Paris , France"},{"name":"Research Team EA7323 \u201cPharmacology and Therapeutic Assessment in Children and Pregnant Women\u201d, Universit\u00e9 Paris Cit\u00e9 , Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,3,25]]},"reference":[{"key":"2023050300200718300_dkad087-B1","doi-asserted-by":"crossref","first-page":"522","DOI":"10.1086\/600882","article-title":"Birth prevalence and natural history of congenital cytomegalovirus infection in a highly seroimmune population","volume":"49","author":"Mussi-Pinhata","year":"2009","journal-title":"Clin Infect Dis"},{"key":"2023050300200718300_dkad087-B2","doi-asserted-by":"crossref","first-page":"330","DOI":"10.1016\/j.ajog.2020.02.018","article-title":"Cytomegalovirus infection during pregnancy: state of the science","volume":"223","author":"Leruez-Ville","year":"2020","journal-title":"Am J Obstet 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