{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T02:45:00Z","timestamp":1791945900342,"version":"4.3.4"},"reference-count":19,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T00:00:00Z","timestamp":1790553600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T00:00:00Z","timestamp":1790553600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100017596","name":"Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte","doi-asserted-by":"publisher","award":["FKZ V\u20102020.10\/68605\/2022\u20102025"],"award-info":[{"award-number":["FKZ V\u20102020.10\/68605\/2022\u20102025"]}],"id":[{"id":"10.13039\/100017596","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>This observational cohort study aimed to assess the risk of adverse pregnancy and neonatal outcomes in pregnancies exposed to statins during the first trimester, given that the use of statins during pregnancy remains controversial. The primary study endpoints were the rates of spontaneous abortion and major birth defects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In total, 188 pregnancies exposed to statins in the first trimester were compared with a cohort of 564 pregnancies without the study medication, which were recorded at the Embryotox Centre between January 2000 and June 2021. The effect of statin exposure on pregnancy outcome was estimated using Cox proportional hazards regression models. Log\u2010binomial regression was used to evaluate the risk of major birth defects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Major birth defects were observed in 10 of 135 (7.4%) infants in the statin cohort and in 12 of 501 (2.4%) infants in the comparison cohort (RR 3.09, 95% CI 1.37\u20137.00). After adjustment for relevant baseline covariates and additional maternal disease factors, the difference substantially attenuated (RRadj 2.16; 95% CI 0.88\u20135.31). The cumulative incidence of spontaneous abortion was 26.8% in the statin\u2010exposed versus 15.0% in the comparison cohort (HR 1.86, 95% CI 1.13\u20133.04; HRadj 1.66, 95% CI 0.99\u20132.78).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Current evidence suggests that statins are not major teratogens. The observed associations between statin exposure and birth defects, as well as unfavourable pregnancy outcomes, are presumably influenced by confounding factors such as underlying maternal disease. Our study results lend support to this assumption. However, they should be interpreted cautiously due to the limited cohort size.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70481","type":"journal-article","created":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T14:10:41Z","timestamp":1790604641000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pregnancy Outcome After First\u2010Trimester Exposure to Statins: Study Results Based on the Embryotox Cohort"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1008-8563","authenticated-orcid":false,"given":"Evelin","family":"Beck","sequence":"first","affiliation":[{"name":"Charit\u00e9\u2014University Medical Center Berlin, Corporate Member of Freie Universit\u00e4t Berlin and Humboldt\u2010Universit\u00e4t zu Berlin, Institute of Clinical Pharmacology and Toxicology, Embryotox Centre of Clinical Teratology and Drug Safety in Pregnancy  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea T.","family":"Adelsberger","sequence":"additional","affiliation":[{"name":"Charit\u00e9\u2014University Medical Center Berlin, Corporate Member of Freie Universit\u00e4t Berlin and Humboldt\u2010Universit\u00e4t zu Berlin, Institute of Clinical Pharmacology and Toxicology, Embryotox Centre of Clinical Teratology and Drug Safety in Pregnancy  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8674-5817","authenticated-orcid":false,"given":"Katarina","family":"Dathe","sequence":"additional","affiliation":[{"name":"Charit\u00e9\u2014University Medical Center Berlin, Corporate Member of Freie Universit\u00e4t Berlin and Humboldt\u2010Universit\u00e4t zu Berlin, Institute of Clinical Pharmacology and Toxicology, Embryotox Centre of Clinical Teratology and Drug Safety in Pregnancy  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,28]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehaf592"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2022.1003060"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15423"},{"key":"e_1_2_11_5_1","unstructured":"European Medicines Agency (EMA) \u201cLipitor\u2014Article 30 Referral. Annex III\u2014Summary of Product Characteristics Labelling and Package Leaflet\u201d(2012) https:\/\/www.ema.europa.eu\/en\/documents\/referral\/lipitor\u2010article\u201030\u2010referral\u2010annex\u2010iii_en.pdf."},{"key":"e_1_2_11_6_1","unstructured":"U.S. Food and Drug Administration (FDA) \u201cFDA Requests Removal of Strongest Warning Against Using Cholesterol\u2010Lowering Statins During Pregnancy; Still Advises Most Pregnant Patients Should Stop Taking Statins \u201dhttps:\/\/www.fda.gov\/drugs\/fda\u2010drug\u2010safety\u2010podcasts\/fda\u2010requests\u2010removal\u2010strongest\u2010warning\u2010against\u2010using\u2010cholesterol\u2010lowering\u2010statins\u2010during\u2010pregnancy."},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228\u2010017\u20102351\u2010y"},{"key":"e_1_2_11_8_1","volume-title":"EUROCAT Guide 1.5","author":"European Platform on Rare Disease Registration"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2008.06.006"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100034\u20101385857"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100034\u20101385858"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/9781119482260"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2016.11.019"},{"key":"e_1_2_11_14_1","volume-title":"EUROCAT Prevalence Charts and Tables. Updated Data Including Birth Year 2023, Excluding Genetic Anomalies","author":"European Platform on Rare Disease Registration"},{"key":"e_1_2_11_15_1","volume-title":"Jahresbericht Des Bundeslandes Sachsen\u2010Anhalt Zur H\u00e4ufigkeit von Congenitalen Fehlbildungen und Anomalien Sowie Genetisch Bedingten Erkrankungen 2024","author":"G\u00f6tz D.","year":"2025"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.h1035"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2018.07.002"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471\u20100528.12066"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.41321"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.reprotox.2008.06.009"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.70481","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/pds.70481","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.70481","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T01:58:12Z","timestamp":1791943092000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.70481"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,28]]},"references-count":19,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1002\/pds.70481"],"URL":"https:\/\/doi.org\/10.1002\/pds.70481","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,28]]},"assertion":[{"value":"2026-04-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-15","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-28","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70481"}}