title: Use of ondansetron during pregnancy and congenital malformations in the infant.
abstract: The study investigates teratogenic risks with ondansetron (Zofran(®)). Data from the Swedish Medical Birth Register combined with the Swedish Register of Prescribed Drugs were used to identify 1349 infants born of women who had taken ondansetron in early pregnancy, 1998-2012. Presence of congenital malformations in the offspring was identified with three national health registers. In a Mantel-Haenszel analysis adjustment was made for year of delivery, maternal age, parity, smoking in early pregnancy and pre-pregnancy body mass index. Risks were expressed as odds or risk ratios with 95% confidence intervals. No statistically significantly increased risk for a major malformation was found. The risks for a cardiovascular defect and notably a cardiac septum defect were increased and statistically significant (OR=1.62, 95% CI 1.04-2.14, and RR 2.05, 95% CI 1.19-3.28, respective). The teratogenic risk with ondansetron is low but an increased risk for a cardiac septum defect is likely.
authors.affiliation: National Board of Health and Welfare, Stockholm, Sweden. Electronic address: bengt.danielsson@socialstyrelsen.se.
authors.forename: Bengt
authors.initials: B
authors.lastname: Danielsson
authors.affiliation: National Board of Health and Welfare, Stockholm, Sweden.
authors.forename: Birgitta Norstedt
authors.initials: BN
authors.lastname: Wikner
authors.affiliation: Tornblad Institute, Lund University, Lund, Sweden.
authors.forename: Bengt
authors.initials: B
authors.lastname: Källén
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000932:Antiemetics / Q000009:adverse effects*; D005260:Female; D006343:Heart Septal Defects / Q000139:chemically induced; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D017294:Ondansetron / Q000009:adverse effects*; D011247:Pregnancy; D012702:Serotonin Antagonists / Q000009:adverse effects*
chemical_list: D000932:Antiemetics; D012702:Serotonin Antagonists; D017294:Ondansetron
keywords: Antiemetics; Cardiovascular defects; Congenital malformations; Meclozine; Nausea and vomiting in pregnancy; Ondansetron