{"database":"biostudies-literature","file_versions":[],"scores":{"citationCount":0,"reanalysisCount":0,"viewCount":54,"searchCount":0},"additional":{"submitter":["Huybrechts KF"],"funding":["NICHD NIH HHS","NIA NIH HHS","NIMH NIH HHS"],"pagination":["2429-2437"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC6669077"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["320(23)"],"pubmed_abstract":["<h4>Importance</h4>Evidence for the fetal safety of ondansetron, a 5-HT3 receptor antagonist that is commonly prescribed for nausea and vomiting during pregnancy, is limited and conflicting.<h4>Objective</h4>To evaluate the association between ondansetron exposure during pregnancy and risk of congenital malformations.<h4>Design, setting, and participants</h4>A retrospective cohort study nested in the 2000-2013 nationwide Medicaid Analytic eXtract. The cohort consisted of 1 816 414 pregnancies contributed by 1 502 895 women enrolled in Medicaid from 3 months before the last menstrual period through 1 month or longer after delivery; infants were enrolled in Medicaid for at least 3 months after birth. The final date of follow-up was December 31, 2013. Analyses were conducted between November 1, 2017, and June 30, 2018. Propensity score stratification was used to control for treatment indication and other confounders.<h4>Exposures</h4>Ondansetron dispensing during the first trimester, the period of organogenesis.<h4>Main outcomes and measures</h4>Primary outcomes were cardiac malformations and oral clefts diagnosed during the first 90 days after delivery. Secondary outcomes included congenital malformations overall and subgroups of cardiac malformations and oral clefts.<h4>Results</h4>Among 1 816 414 pregnancies (mean age of mothers, 24.3 [5.8] years), 88 467 (4.9%) were exposed to ondansetron during the first trimester. Overall, 14 577 of 1 727 947 unexposed and 835 of 88 467 exposed infants were diagnosed with a cardiac malformation, for an absolute risk of 84.4 (95% CI, 83.0 to 85.7) and 94.4 (95% CI, 88.0 to 100.8) per 10 000 births respectively. The absolute risk of oral clefts was 11.1 per 10 000 births (95% CI, 10.6 to 11.6; 1921 unexposed infants) and was 14.0 per 10 000 births (95% CI, 11.6 to 16.5; 124 exposed infants). The risk of any congenital malformation was 313.5 per 10 000 births (95% CI, 310.9 to 316.1; 54 174 unexposed infants) and was 370.4 (95% CI, 358.0 to 382.9; 3277 exposed infants). The adjusted relative risk (RR) for cardiac malformations was 0.99 (95% CI, 0.93 to 1.06) and the adjusted risk difference (RD) was -0.8 (95% CI, -7.3 to 5.7 per 10 000 births). For oral clefts, the adjusted RR was 1.24 (95% CI, 1.03 to 1.48) and the RD was 2.7 (95% CI, 0.2 to 5.2 per 10 000 births). The adjusted estimate for congenital malformations overall was an RR of 1.01 (95% CI, 0.98 to 1.05) and an RD of 5.4 (95% CI, -7.3 to 18.2 per 10 000 births).<h4>Conclusions and relevance</h4>Among offspring of mothers enrolled in Medicaid, first-trimester exposure to ondansetron was not associated with cardiac malformations or congenital malformations overall after accounting for measured confounders but was associated with a small increased risk of oral clefts."],"journal":["JAMA"],"pubmed_title":["Association of Maternal First-Trimester Ondansetron Use With Cardiac Malformations and Oral Clefts in Offspring."],"pmcid":["PMC6669077"],"funding_grant_id":["K08 HD075831","R03 HD091699","K01 MH099141","K08 AG055670"],"pubmed_authors":["Straub L","Zhu Y","Huybrechts KF","Patorno E","Desai RJ","Hernandez-Diaz S","Mogun H","Bateman BT","Gray KJ"],"view_count":["54"],"additional_accession":[]},"is_claimable":false,"name":"Association of Maternal First-Trimester Ondansetron Use With Cardiac Malformations and Oral Clefts in Offspring.","description":"<h4>Importance</h4>Evidence for the fetal safety of ondansetron, a 5-HT3 receptor antagonist that is commonly prescribed for nausea and vomiting during pregnancy, is limited and conflicting.<h4>Objective</h4>To evaluate the association between ondansetron exposure during pregnancy and risk of congenital malformations.<h4>Design, setting, and participants</h4>A retrospective cohort study nested in the 2000-2013 nationwide Medicaid Analytic eXtract. The cohort consisted of 1 816 414 pregnancies contributed by 1 502 895 women enrolled in Medicaid from 3 months before the last menstrual period through 1 month or longer after delivery; infants were enrolled in Medicaid for at least 3 months after birth. The final date of follow-up was December 31, 2013. Analyses were conducted between November 1, 2017, and June 30, 2018. Propensity score stratification was used to control for treatment indication and other confounders.<h4>Exposures</h4>Ondansetron dispensing during the first trimester, the period of organogenesis.<h4>Main outcomes and measures</h4>Primary outcomes were cardiac malformations and oral clefts diagnosed during the first 90 days after delivery. Secondary outcomes included congenital malformations overall and subgroups of cardiac malformations and oral clefts.<h4>Results</h4>Among 1 816 414 pregnancies (mean age of mothers, 24.3 [5.8] years), 88 467 (4.9%) were exposed to ondansetron during the first trimester. Overall, 14 577 of 1 727 947 unexposed and 835 of 88 467 exposed infants were diagnosed with a cardiac malformation, for an absolute risk of 84.4 (95% CI, 83.0 to 85.7) and 94.4 (95% CI, 88.0 to 100.8) per 10 000 births respectively. The absolute risk of oral clefts was 11.1 per 10 000 births (95% CI, 10.6 to 11.6; 1921 unexposed infants) and was 14.0 per 10 000 births (95% CI, 11.6 to 16.5; 124 exposed infants). The risk of any congenital malformation was 313.5 per 10 000 births (95% CI, 310.9 to 316.1; 54 174 unexposed infants) and was 370.4 (95% CI, 358.0 to 382.9; 3277 exposed infants). The adjusted relative risk (RR) for cardiac malformations was 0.99 (95% CI, 0.93 to 1.06) and the adjusted risk difference (RD) was -0.8 (95% CI, -7.3 to 5.7 per 10 000 births). For oral clefts, the adjusted RR was 1.24 (95% CI, 1.03 to 1.48) and the RD was 2.7 (95% CI, 0.2 to 5.2 per 10 000 births). The adjusted estimate for congenital malformations overall was an RR of 1.01 (95% CI, 0.98 to 1.05) and an RD of 5.4 (95% CI, -7.3 to 18.2 per 10 000 births).<h4>Conclusions and relevance</h4>Among offspring of mothers enrolled in Medicaid, first-trimester exposure to ondansetron was not associated with cardiac malformations or congenital malformations overall after accounting for measured confounders but was associated with a small increased risk of oral clefts.","dates":{"release":"2018-01-01T00:00:00Z","publication":"2018 Dec","modification":"2024-02-15T15:35:04.188Z","creation":"2020-05-21T23:37:13Z"},"accession":"S-EPMC6669077","cross_references":{"pubmed":["30561479"],"doi":["10.1001/jama.2018.18307"]}}