{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T08:39:44Z","timestamp":1780475984477,"version":"3.54.1"},"reference-count":53,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T00:00:00Z","timestamp":1740528000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T00:00:00Z","timestamp":1740528000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100003323","name":"Agence Nationale de Recherches sur le Sida et les H\u00e9patites Virales","doi-asserted-by":"publisher","award":["12433 B112"],"award-info":[{"award-number":["12433 B112"]}],"id":[{"id":"10.13039\/501100003323","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004718","name":"Universit\u00e9 de Toulouse","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100004718","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Clin Pharmacol"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Purpose<\/jats:title>\n            <jats:p>Antiretroviral drugs are recommended during pregnancy to achieve HIV viral suppression and reduce mother-to-child transmission. Congenital anomaly signals were reported after fetal exposure to antiretroviral drugs in several studies warranting further investigation. We aimed to evaluate the risk of congenital anomalies after fetal exposure to antiretroviral drugs using the European congenital anomaly registry data.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>A case\/non-case study was performed, using the EUROmediCAT central database. All the congenital anomalies, exposed to any antiretroviral drugs, were included from 1995 to 2019. We explored each signal identified from the literature for associations between congenital anomalies and specific antiretroviral exposures. We compared antiretroviral exposure between the signal anomalies (cases) and all other malformed registrations (controls). Reporting odds ratio (ROR) and their 95% confidence intervals were estimated and adjusted for registry and maternal age.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Between 1995 and 2019, 173 cases of congenital anomalies were observed after any exposure to antiretroviral drugs. The signal previously identified in the literature between congenital heart defects and exposure to zidovudine was confirmed in the main analysis (aROR 3.66 [1.63\u20138.23]). Other signals identified in the literature were not confirmed, although two cases of hypospadias and two cases of limb defects were reported after zidovudine and atazanavir exposure, respectively. The signal detection analysis did not reveal any new signal after applying the Bonferroni correction.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Our study does not reveal new signals but confirms the previously identified signal between congenital heart defects and fetal exposure to zidovudine. The physio-pathological hypothesis induced by zidovudine exposure should be explored in future studies.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s00228-025-03814-w","type":"journal-article","created":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T20:56:02Z","timestamp":1740603362000},"page":"697-709","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Antiretroviral drug exposure in pregnancy and risk of congenital anomalies: a European case\/non-case malformed study"],"prefix":"10.1007","volume":"81","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3069-4341","authenticated-orcid":false,"given":"Laura","family":"Saint-Lary","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4631-100X","authenticated-orcid":false,"given":"Anna-Belle","family":"Beau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7980-5650","authenticated-orcid":false,"given":"Agn\u00e8s","family":"Sommet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3542-8616","authenticated-orcid":false,"given":"Val\u00e9riane","family":"Leroy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1206-3637","authenticated-orcid":false,"given":"Maria","family":"Loane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4858-6456","authenticated-orcid":false,"given":"Clara","family":"Cavero-Carbonell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0430-2594","authenticated-orcid":false,"given":"Ester","family":"Garne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Hoareau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9152-1674","authenticated-orcid":false,"given":"Anna Latos","family":"Bielenska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2755-7322","authenticated-orcid":false,"given":"Isabelle","family":"Monier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5180-4565","authenticated-orcid":false,"given":"Vera","family":"Nelen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda J.","family":"Neville","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"O\u2019Mahony","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3845-6180","authenticated-orcid":false,"given":"Isabelle","family":"Perthus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3321-9343","authenticated-orcid":false,"given":"Anna","family":"Pierini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9437-2790","authenticated-orcid":false,"given":"Anke","family":"Rissmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5514-0893","authenticated-orcid":false,"given":"Florence","family":"Rouget","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4453-1167","authenticated-orcid":false,"given":"Joanna","family":"Sichitiu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3077-5918","authenticated-orcid":false,"given":"David","family":"Tucker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6639-5904","authenticated-orcid":false,"given":"Helen","family":"Dolk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5018-0108","authenticated-orcid":false,"given":"Christine","family":"Damase-Michel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,2,26]]},"reference":[{"key":"3814_CR1","unstructured":"UNAIDS. Global HIV & AIDS statistics \u2014 Fact sheet 2023. UNAIDS 2023. https:\/\/www.unaids.org\/en\/resources\/fact-sheet (accessed March 2, 2023)."},{"key":"3814_CR2","doi-asserted-by":"publisher","first-page":"e33","DOI":"10.1016\/S2352-3018(15)00207-6","volume":"3","author":"COO Wedi","year":"2016","unstructured":"Wedi COO, Kirtley S, Hopewell S, Corrigan R, Kennedy SH, Hemelaar J (2016) Perinatal outcomes associated with maternal HIV infection: a systematic review and meta-analysis. Lancet HIV 3:e33-48. https:\/\/doi.org\/10.1016\/S2352-3018(15)00207-6","journal-title":"Lancet HIV"},{"key":"3814_CR3","unstructured":"WHO. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants n.d. https:\/\/www.who.int\/publications\/i\/item\/9789241599818 (accessed July 10, 2024)."},{"key":"3814_CR4","unstructured":"WHO. HIV\/AIDS - Key facts 2020. https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/hiv-aids (accessed January 9, 2019)."},{"key":"3814_CR5","doi-asserted-by":"publisher","first-page":"1715","DOI":"10.1093\/cid\/civ578","volume":"61","author":"L Mandelbrot","year":"2015","unstructured":"Mandelbrot L, Tubiana R, Le Chenadec J, Dollfus C, Faye A, Pannier E et al (2015) No perinatal HIV-1 transmission from women with effective antiretroviral therapy starting before conception. Clin Infect Dis Off Publ Infect Dis Soc Am 61:1715\u20131725. https:\/\/doi.org\/10.1093\/cid\/civ578","journal-title":"Clin Infect Dis Off Publ Infect Dis Soc Am"},{"key":"3814_CR6","doi-asserted-by":"publisher","unstructured":"Schulte J, Dominguez K, Sukalac T, Bohannon B, Fowler MG, for the Pediatric Spectrum of HIV Disease Consortium. (2007)Declines in low birth weight and preterm birth among infants who were born to HIV-infected women during an era of increased use of maternal antiretroviral drugs: pediatric spectrum of HIV disease, 1989\u20132004. PEDIATRICS 2007;119:e900\u20136. https:\/\/doi.org\/10.1542\/peds.2006-1123.","DOI":"10.1542\/peds.2006-1123"},{"key":"3814_CR7","doi-asserted-by":"publisher","first-page":"70","DOI":"10.1001\/jama.2011.915","volume":"306","author":"A Simon","year":"2011","unstructured":"Simon A, Warszawski J, Kariyawasam D, Le Chenadec J, Benhammou V, Czernichow P et al (2011) Association of prenatal and postnatal exposure to lopinavir-ritonavir and adrenal dysfunction among uninfected infants of HIV-infected mothers. JAMA 306:70\u201378. https:\/\/doi.org\/10.1001\/jama.2011.915","journal-title":"JAMA"},{"key":"3814_CR8","doi-asserted-by":"publisher","first-page":"1348","DOI":"10.1093\/cid\/cis198","volume":"54","author":"J Sibiude","year":"2012","unstructured":"Sibiude J, Warszawski J, Tubiana R, Dollfus C, Faye A, Rouzioux C et al (2012) Premature delivery in HIV-infected women starting protease inhibitor therapy during pregnancy: role of the ritonavir boost? Clin Infect Dis Off Publ Infect Dis Soc Am 54:1348\u20131360. https:\/\/doi.org\/10.1093\/cid\/cis198","journal-title":"Clin Infect Dis Off Publ Infect Dis Soc Am"},{"key":"3814_CR9","doi-asserted-by":"publisher","first-page":"84","DOI":"10.1111\/hiv.12798","volume":"21","author":"M \u00d8rbaek","year":"2020","unstructured":"\u00d8rbaek M, Thorsteinsson K, Moseholm Larsen E, Katzenstein TL, Storgaard M, Johansen IS et al (2020) Risk factors during pregnancy and birth-related complications in HIV-positive versus HIV-negative women in Denmark, 2002\u20132014. HIV Med 21:84\u201395. https:\/\/doi.org\/10.1111\/hiv.12798","journal-title":"HIV Med"},{"issue":"1","key":"3814_CR10","doi-asserted-by":"publisher","first-page":"e49","DOI":"10.1016\/S2352-3018(19)30340-6","volume":"7","author":"PL Williams","year":"2020","unstructured":"Williams PL, Yildirim C, Chadwick EG, Van Dyke RB, Smith R, Correia KF, DiPerna A, Seage GR 3rd, Hazra R, Crowell CS (2020) Association of maternal antiretroviral use with microcephaly in children who are HIV-exposed but uninfected (SMARTT): a prospective cohort study. Lancet HIV 7(1):e49\u2013e58. https:\/\/doi.org\/10.1016\/S2352-3018(19)30340-6","journal-title":"Lancet HIV"},{"key":"3814_CR11","doi-asserted-by":"publisher","first-page":"1466","DOI":"10.1111\/1471-0528.12285","volume":"120","author":"M Floridia","year":"2013","unstructured":"Floridia M, Mastroiacovo P, Tamburrini E, Tibaldi C, Todros T, Crepaldi A et al (2013) Birth defects in a national cohort of pregnant women with HIV infection in Italy, 2001\u20132011. BJOG Int J Obstet Gynaecol 120:1466\u20131475. https:\/\/doi.org\/10.1111\/1471-0528.12285","journal-title":"BJOG Int J Obstet Gynaecol"},{"issue":"42","key":"3814_CR12","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1097\/01.qai.0000196667.24239.c2","volume":"2006","author":"CL Townsend","year":"1999","unstructured":"Townsend CL, Tookey PA, Cortina-Borja M, Peckham CS (1999) Antiretroviral therapy and congenital abnormalities in infants born to HIV-1-infected women in the United Kingdom and Ireland, 1990 to 2003. J Acquir Immune Defic Syndr 2006(42):91\u201394. https:\/\/doi.org\/10.1097\/01.qai.0000196667.24239.c2","journal-title":"J Acquir Immune Defic Syndr"},{"key":"3814_CR13","doi-asserted-by":"publisher","first-page":"6","DOI":"10.1111\/j.1468-1293.2008.00520.x","volume":"9","author":"I Grosch-Woerner","year":"2008","unstructured":"Grosch-Woerner I, Puch K, Maier RF, Niehues T, Notheis G, Patel D et al (2008) Increased rate of prematurity associated with antenatal antiretroviral therapy in a German\/Austrian cohort of HIV-1-infected women. HIV Med 9:6\u201313. https:\/\/doi.org\/10.1111\/j.1468-1293.2008.00520.x","journal-title":"HIV Med"},{"issue":"53","key":"3814_CR14","doi-asserted-by":"publisher","first-page":"176","DOI":"10.1097\/QAI.0b013e3181c5c81f","volume":"2010","author":"EC Joao","year":"1999","unstructured":"Joao EC, Calvet GA, Krauss MR, Freimanis Hance L, Ortiz J, Ivalo SA et al (1999) Maternal antiretroviral use during pregnancy and infant congenital anomalies: the NISDI perinatal study. J Acquir Immune Defic Syndr 2010(53):176\u2013185. https:\/\/doi.org\/10.1097\/QAI.0b013e3181c5c81f","journal-title":"J Acquir Immune Defic Syndr"},{"key":"3814_CR15","unstructured":"WHO. (2016) Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection 2016. https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/208825\/9789241549684_eng.pdf?sequence=1 (accessed December 14, 2020)."},{"key":"3814_CR16","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15075","author":"L Saint-Lary","year":"2021","unstructured":"Saint-Lary L, Diallo A, de Monteynard L-A, Paul C, Marchand L, Tubiana R et al (2021) In utero exposure to antiretroviral drugs and pregnancy outcomes: analysis of the French ANRS pharmacovigilance database. Br J Clin Pharmacol. https:\/\/doi.org\/10.1111\/bcp.15075","journal-title":"Br J Clin Pharmacol"},{"key":"3814_CR17","doi-asserted-by":"publisher","first-page":"80","DOI":"10.1186\/s12884-023-05347-5","volume":"23","author":"L Saint-Lary","year":"2023","unstructured":"Saint-Lary L, Benevent J, Damase-Michel C, Vayssi\u00e8re C, Leroy V, Sommet A (2023) Adverse perinatal outcomes associated with prenatal exposure to protease-inhibitor-based versus non-nucleoside reverse transcriptase inhibitor-based antiretroviral combinations in pregnant women with HIV infection: a systematic review and meta-analysis. BMC Pregnancy Childbirth 23:80. https:\/\/doi.org\/10.1186\/s12884-023-05347-5","journal-title":"BMC Pregnancy Childbirth"},{"issue":"44","key":"3814_CR18","doi-asserted-by":"publisher","first-page":"299","DOI":"10.1097\/QAI.0b013e31802e2229","volume":"2007","author":"DH Watts","year":"1999","unstructured":"Watts DH, Li D, Handelsman E, Tilson H, Paul M, Foca M et al (1999) Assessment of birth defects according to maternal therapy among infants in the Women and Infants Transmission Study. J Acquir Immune Defic Syndr 2007(44):299\u2013305. https:\/\/doi.org\/10.1097\/QAI.0b013e31802e2229","journal-title":"J Acquir Immune Defic Syndr"},{"key":"3814_CR19","doi-asserted-by":"publisher","first-page":"583","DOI":"10.1016\/S0140-6736(02)07717-6","volume":"359","author":"A Landreau-Mascaro","year":"2002","unstructured":"Landreau-Mascaro A, Barret B, Mayaux MJ, Tardieu M, Blanche S, French PerinatalCohortStudy Group (2002) Risk of early febrile seizure with perinatal exposure to nucleoside analogues. Lancet Lond Engl. 359:583\u20134. https:\/\/doi.org\/10.1016\/S0140-6736(02)07717-6","journal-title":"Lancet Lond Engl."},{"key":"3814_CR20","doi-asserted-by":"publisher","first-page":"721","DOI":"10.1097\/INF.0b013e3181e74a2f","volume":"29","author":"SB Brogly","year":"2010","unstructured":"Brogly SB, Abzug MJ, Watts DH, Cunningham CK, Williams PL, Oleske J et al (2010) Birth defects among children born to human immunodeficiency virus-infected women: pediatric AIDS clinical trials protocols 219 and 219C. Pediatr Infect Dis J 29:721\u2013727. https:\/\/doi.org\/10.1097\/INF.0b013e3181e74a2f","journal-title":"Pediatr Infect Dis J"},{"key":"3814_CR21","doi-asserted-by":"publisher","first-page":"48","DOI":"10.1001\/jamapediatrics.2014.1889","volume":"169","author":"PL Williams","year":"2015","unstructured":"Williams PL, Crain MJ, Yildirim C, Hazra R, Van Dyke RB, Rich K et al (2015) Congenital anomalies and in utero antiretroviral exposure in human immunodeficiency virus-exposed uninfected infants. JAMA Pediatr 169:48\u201355. https:\/\/doi.org\/10.1001\/jamapediatrics.2014.1889","journal-title":"JAMA Pediatr"},{"key":"3814_CR22","doi-asserted-by":"publisher","first-page":"355","DOI":"10.1001\/archinte.162.3.355","volume":"162","author":"M De Santis","year":"2002","unstructured":"De Santis M, Carducci B, De Santis L, Cavaliere AF, Straface G (2002) Periconceptional Exposure to Efavirenz and Neural Tube Defects. Arch Intern Med 162:355\u2013356","journal-title":"Arch Intern Med"},{"issue":"7","key":"3814_CR23","doi-asserted-by":"publisher","first-page":"e716","DOI":"10.1016\/S2214-109X(18)30272-9","volume":"6","author":"LM Mofenson","year":"2018","unstructured":"Mofenson LM (2018) In-utero ART exposure and the need for pharmacovigilance. The Lancet Global Health 6(7):e716\u2013e717. https:\/\/doi.org\/10.1016\/S2214-109X(18)30272-9","journal-title":"The Lancet Global Health"},{"key":"3814_CR24","unstructured":"Hampton SG (2018) Update recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV. WHO. https:\/\/iris.who.int\/bitstream\/handle\/10665\/273632\/WHO-CDS-HIV-18.18-eng.pdf"},{"key":"3814_CR25","doi-asserted-by":"publisher","first-page":"e716","DOI":"10.1016\/S2214-109X(18)30218-3","volume":"6","author":"R Zash","year":"2018","unstructured":"Zash R, Jacobson DL, Diseko M, Mayondi G, Mmalane M, Essex M et al (2018) Comparative safety of dolutegravir-based or efavirenz-based antiretroviral treatment started during pregnancy in Botswana: an observational study - ScienceDirect. Lancet Glob Health 6:e716","journal-title":"Lancet Glob Health"},{"key":"3814_CR26","doi-asserted-by":"publisher","first-page":"6","DOI":"10.1016\/j.ejogrb.2015.11.015","volume":"197","author":"V Vannappagari","year":"2016","unstructured":"Vannappagari V, Albano JD, Koram N, Tilson H, Scheuerle AE, Napier MD (2016) Prenatal exposure to zidovudine and risk for ventricular septal defects and congenital heart defects: data from the Antiretroviral Pregnancy Registry. Eur J Obstet Gynecol Reprod Biol 197:6\u201310. https:\/\/doi.org\/10.1016\/j.ejogrb.2015.11.015","journal-title":"Eur J Obstet Gynecol Reprod Biol"},{"key":"3814_CR27","unstructured":"WHO. (2012) Use of efavirenz during pregnancy: a public health perspective. WHO 2012. https:\/\/www.who.int\/hiv\/pub\/treatment2\/efavirenz\/en\/ (accessed May 14, 2021)."},{"key":"3814_CR28","doi-asserted-by":"publisher","first-page":"979","DOI":"10.1056\/NEJMc1807653","volume":"379","author":"R Zash","year":"2018","unstructured":"Zash R, Makhema J, Shapiro RL (2018) Neural-tube defects with dolutegravir treatment from the time of conception. N Engl J Med 379:979\u2013981. https:\/\/doi.org\/10.1056\/NEJMc1807653","journal-title":"N Engl J Med"},{"key":"3814_CR29","doi-asserted-by":"publisher","first-page":"827","DOI":"10.1056\/NEJMoa1905230","volume":"381","author":"R Zash","year":"2019","unstructured":"Zash R, Holmes L, Diseko M, Jacobson DL, Brummel S, Mayondi G et al (2019) Neural-tube defects and antiretroviral treatment regimens in Botswana. N Engl J Med 381:827\u2013840. https:\/\/doi.org\/10.1056\/NEJMoa1905230","journal-title":"N Engl J Med"},{"key":"3814_CR30","unstructured":"WHO (2019) Update of recommendations on first- and second-line antiretroviral regimens. WHO. https:\/\/iris.who.int\/bitstream\/handle\/10665\/325892\/WHO-CDS-HIV-19.15-eng.pdf?ua=1"},{"key":"3814_CR31","unstructured":"WHO. (2021) Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach 2021. https:\/\/www.who.int\/publications-detail-redirect\/9789240031593 (accessed December 15, 2021)."},{"key":"3814_CR32","unstructured":"2021 ACSoMP recommendations n.d. https:\/\/www.who.int\/publications\/m\/item\/2021-acsomp-recommendations (accessed March 2, 2023)."},{"key":"3814_CR33","doi-asserted-by":"publisher","first-page":"e25922","DOI":"10.1002\/jia2.25922","volume":"25","author":"F Renaud","year":"2022","unstructured":"Renaud F, Mofenson LM, Bakker C, Dolk H, Leroy V, Namiba A et al (2022) Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework. J Int AIDS Soc 25:e25922. https:\/\/doi.org\/10.1002\/jia2.25922","journal-title":"J Int AIDS Soc"},{"key":"3814_CR34","unstructured":"EUROmediCAT n.d. https:\/\/www.euromedicat.eu\/whatiseuromedicat (accessed October 5, 2023)."},{"key":"3814_CR35","unstructured":"EUROCAT. (2013) EUROCAT Guide 1.4: instruction for the registration of congenital anomalies. EUROCAT Central Registry, University of Ulster 2013. https:\/\/eu-rd-platform.jrc.ec.europa.eu\/sites\/default\/files\/Full_Guide_1_4_version_28_DEC2018.pdf (accessed September 13, 2019)."},{"key":"3814_CR36","doi-asserted-by":"publisher","first-page":"905","DOI":"10.1111\/j.1365-2125.2011.04037.x","volume":"72","author":"J-L Montastruc","year":"2011","unstructured":"Montastruc J-L, Sommet A, Bagheri H, Lapeyre-Mestre M (2011) Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol 72:905\u2013908. https:\/\/doi.org\/10.1111\/j.1365-2125.2011.04037.x","journal-title":"Br J Clin Pharmacol"},{"key":"3814_CR37","doi-asserted-by":"publisher","first-page":"e2435","DOI":"10.1002\/bdr2.2435","volume":"117","author":"E-A Cifuentes","year":"2025","unstructured":"Cifuentes E-A, Beau A, Caillet A, Fr\u00e9mont F, Neville AJ, Ballardini E et al (2025) Risk of congenital ocular anomaly after prenatal exposure to medications: a EUROmediCAT study. Birth Defects Res 117:e2435. https:\/\/doi.org\/10.1002\/bdr2.2435","journal-title":"Birth Defects Res"},{"key":"3814_CR38","doi-asserted-by":"publisher","first-page":"1496","DOI":"10.1016\/j.jaci.2015.05.043","volume":"136","author":"E Garne","year":"2015","unstructured":"Garne E, Hansen AV, Morris J, Zaupper L, Addor M-C, Barisic I et al (2015) Use of asthma medication during pregnancy and risk of specific congenital anomalies: a European case-malformed control study. J Allergy Clin Immunol 136:1496-1502.e7. https:\/\/doi.org\/10.1016\/j.jaci.2015.05.043","journal-title":"J Allergy Clin Immunol"},{"key":"3814_CR39","doi-asserted-by":"publisher","first-page":"415","DOI":"10.1007\/s40264-017-0627-x","volume":"41","author":"JEH Bergman","year":"2018","unstructured":"Bergman JEH, Lutke LR, Gans ROB, Addor M-C, Barisic I, Cavero-Carbonell C et al (2018) Beta-blocker use in pregnancy and risk of specific congenital anomalies: a European case-malformed control study. Drug Saf 41:415\u2013427. https:\/\/doi.org\/10.1007\/s40264-017-0627-x","journal-title":"Drug Saf"},{"key":"3814_CR40","doi-asserted-by":"publisher","first-page":"225","DOI":"10.1016\/j.therap.2019.01.006","volume":"74","author":"J-L Faillie","year":"2019","unstructured":"Faillie J-L (2019) Case-non-case studies: principle, methods, bias and interpretation. Therapie 74:225\u2013232. https:\/\/doi.org\/10.1016\/j.therap.2019.01.006","journal-title":"Therapie"},{"key":"3814_CR41","doi-asserted-by":"publisher","first-page":"e1001635","DOI":"10.1371\/journal.pmed.1001635","volume":"11","author":"J Sibiude","year":"2014","unstructured":"Sibiude J, Mandelbrot L, Blanche S, Le Chenadec J, Boullag-Bonnet N, Faye A et al (2014) Association between prenatal exposure to antiretroviral therapy and birth defects: an analysis of the French perinatal cohort study (ANRS CO1\/CO11). PLoS Med 11:e1001635. https:\/\/doi.org\/10.1371\/journal.pmed.1001635","journal-title":"PLoS Med"},{"key":"3814_CR42","doi-asserted-by":"publisher","first-page":"270","DOI":"10.1093\/cid\/civ260","volume":"61","author":"J Sibiude","year":"2015","unstructured":"Sibiude J, Le Chenadec J, Bonnet D, Tubiana R, Faye A, Dollfus C et al (2015) In utero exposure to zidovudine and heart anomalies in the ANRS French perinatal cohort and the nested PRIMEVA randomized trial. Clin Infect Dis 61:270\u2013280. https:\/\/doi.org\/10.1093\/cid\/civ260","journal-title":"Clin Infect Dis"},{"key":"3814_CR43","doi-asserted-by":"publisher","first-page":"e2021008","DOI":"10.4178\/epih.e2021008","volume":"43","author":"FM Alemu","year":"2021","unstructured":"Alemu FM, Yalew AW (2021) Does antiretroviral therapy cause congenital malformations? A systematic review and meta-analysis. Epidemiol Health 43:e2021008. https:\/\/doi.org\/10.4178\/epih.e2021008","journal-title":"Epidemiol Health"},{"key":"3814_CR44","doi-asserted-by":"publisher","first-page":"985","DOI":"10.1016\/j.ajog.2004.05.061","volume":"191","author":"D Heather Watts","year":"2004","unstructured":"Heather Watts D, Covington DL, Beckerman K, Garcia P, Scheuerle A, Dominguez K et al (2004) Assessing the risk of birth defects associated with antiretroviral exposure during pregnancy. Am J Obstet Gynecol 191:985\u2013992. https:\/\/doi.org\/10.1016\/j.ajog.2004.05.061","journal-title":"Am J Obstet Gynecol"},{"issue":"24","key":"3814_CR45","first-page":"249","volume":"2000","author":"CJ Newschaffer","year":"1999","unstructured":"Newschaffer CJ, Cocroft J, Anderson CE, Hauck WW, Turner BJ (1999) Prenatal zidovudine use and congenital anomalies in a Medicaid population. J Acquir Immune Defic Syndr 2000(24):249\u2013256","journal-title":"J Acquir Immune Defic Syndr"},{"key":"3814_CR46","doi-asserted-by":"publisher","first-page":"1733","DOI":"10.1097\/QAD.0000000000001549","volume":"31","author":"K Rough","year":"2017","unstructured":"Rough K, Sun JW, Seage GR, Williams PL, Huybrechts KF, Bateman BT et al (2017) Zidovudine use in pregnancy and congenital malformations. AIDS Lond Engl 31:1733\u20131743. https:\/\/doi.org\/10.1097\/QAD.0000000000001549","journal-title":"AIDS Lond Engl"},{"key":"3814_CR47","doi-asserted-by":"publisher","first-page":"e0198447","DOI":"10.1371\/journal.pone.0198447","volume":"13","author":"AA Veroniki","year":"2018","unstructured":"Veroniki AA, Antony J, Straus SE, Ashoor HM, Finkelstein Y, Khan PA et al (2018) Comparative safety and effectiveness of perinatal antiretroviral therapies for HIV-infected women and their children: systematic review and network meta-analysis including different study designs. PLoS ONE 13:e0198447. https:\/\/doi.org\/10.1371\/journal.pone.0198447","journal-title":"PLoS ONE"},{"key":"3814_CR48","doi-asserted-by":"publisher","first-page":"1046","DOI":"10.1016\/s0140-6736(99)00301-3","volume":"354","author":"AA Morris","year":"1999","unstructured":"Morris AA, Carr A (1999) HIV nucleoside analogues: new adverse effects on mitochondria? Lancet Lond Engl 354:1046\u20131047. https:\/\/doi.org\/10.1016\/s0140-6736(99)00301-3","journal-title":"Lancet Lond Engl"},{"key":"3814_CR49","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1016\/j.mito.2004.05.010","volume":"4","author":"W Lewis","year":"2004","unstructured":"Lewis W (2004) Cardiomyopathy, nucleoside reverse transcriptase inhibitors and mitochondria are linked through AIDS and its therapy. Mitochondrion 4:141\u2013152. https:\/\/doi.org\/10.1016\/j.mito.2004.05.010","journal-title":"Mitochondrion"},{"key":"3814_CR50","doi-asserted-by":"publisher","first-page":"62","DOI":"10.1016\/S0035-3787(06)74983-9","volume":"162","author":"Y G\u00e9rard","year":"2006","unstructured":"G\u00e9rard Y, Melliez H, Mouton Y, Yazdanpanah Y (2006) Cytopathies mitochondriales au cours de l\u2019infection par le VIH. Rev Neurol (Paris) 162:62\u201370. https:\/\/doi.org\/10.1016\/S0035-3787(06)74983-9","journal-title":"Rev Neurol (Paris)"},{"key":"3814_CR51","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz684","author":"NS van De Ven","year":"2019","unstructured":"van De Ven NS, Pozniak AL, Levi JA, Clayden P, Garratt A, Redd C et al (2019) Analysis of pharmacovigilance databases for dolutegravir safety in pregnancy. Clin Infect Dis Off Publ Infect Dis Soc Am. https:\/\/doi.org\/10.1093\/cid\/ciz684","journal-title":"Clin Infect Dis Off Publ Infect Dis Soc Am"},{"key":"3814_CR52","doi-asserted-by":"publisher","first-page":"219","DOI":"10.1097\/QAD.0000000000002719","volume":"35","author":"J Sibiude","year":"2021","unstructured":"Sibiude J, Le Chenadec J, Mandelbrot L, Dollfus C, Matheron S, Lelong N et al (2021) Risk of birth defects and perinatal outcomes in HIV-infected women exposed to integrase strand inhibitors during pregnancy. AIDS Lond Engl 35:219\u2013226. https:\/\/doi.org\/10.1097\/QAD.0000000000002719","journal-title":"AIDS Lond Engl"},{"key":"3814_CR53","doi-asserted-by":"publisher","first-page":"103","DOI":"10.1111\/j.1741-4520.2008.00189.x","volume":"48","author":"AE Czeizel","year":"2008","unstructured":"Czeizel AE (2008) Specified critical period of different congenital abnormalities: a new approach for human teratological studies. Congenit Anom 48:103\u2013109. https:\/\/doi.org\/10.1111\/j.1741-4520.2008.00189.x","journal-title":"Congenit Anom"}],"container-title":["European Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00228-025-03814-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00228-025-03814-w\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00228-025-03814-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,16]],"date-time":"2025-04-16T08:21:21Z","timestamp":1744791681000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00228-025-03814-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,26]]},"references-count":53,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5]]}},"alternative-id":["3814"],"URL":"https:\/\/doi.org\/10.1007\/s00228-025-03814-w","relation":{},"ISSN":["0031-6970","1432-1041"],"issn-type":[{"value":"0031-6970","type":"print"},{"value":"1432-1041","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,26]]},"assertion":[{"value":"13 September 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 February 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 February 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}