title: Off-label use of ondansetron in pregnancy in Western Australia.
abstract: OBJECTIVE
  Nausea and vomiting of pregnancy is the most common medical condition in pregnancy. There is an increasing trend to prescribe ondansetron although its safety for use in pregnancy has not been established.
  
  
  METHODS
  Exposed pregnancies were all births in Western Australia, 2002-2005, where the mother was dispensed ondansetron under the Australian Pharmaceutical Benefits Scheme, compared with all other births during the same period. Outcomes investigated include maternal and child characteristics, birth defects, pregnancy, and delivery characteristics.
  
  
  RESULTS
  There were 96,968 births from 2002 to 2005. Ondansetron was dispensed to 251 pregnant women during this period. The women dispensed ondansetron were more likely to be privately insured (OR: 5.8; 95% CI: 4.3-7.9), to be Caucasian (3.3; 1.9-5.7), not to smoke during their pregnancy (2.9; 1.8-4.7), to have a multiple birth (2.7; 1.5-5.0), and to have used fertility treatment (1.8; 1.0-3.4). There was a small but not significantly increased risk of a major birth defect with first trimester exposure (1.2; 0.6-2.2).
  
  
  CONCLUSIONS
  Our study did not detect any adverse outcomes from the use of ondansetron in pregnancy but could not conclude that ondansetron is safe to use in pregnancy.
authors.affiliation: Telethon Institute for Child Health Research, Centre for Child Health Research, The University of Western Australia, 100 Roberts Road, Subiaco, WA 6008, Australia.
authors.forename: Lyn
authors.initials: L
authors.lastname: Colvin
authors.affiliation: Centre for Neonatal Research and Education, The University of Western Australia, 374 Bagot Road, Subiaco, WA 6008, Australia.
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Gill
authors.affiliation: School of Dentistry, The University of Western Australia, 35 Stirling Highway Crawley, Perth, WA 6009, Australia.
authors.forename: Linda
authors.initials: L
authors.lastname: Slack-Smith
authors.affiliation: Telethon Institute for Child Health Research, Centre for Child Health Research, The University of Western Australia, 100 Roberts Road, Subiaco, WA 6008, Australia.
authors.forename: Fiona J
authors.initials: FJ
authors.lastname: Stanley
authors.affiliation: Telethon Institute for Child Health Research, Centre for Child Health Research, The University of Western Australia, 100 Roberts Road, Subiaco, WA 6008, Australia ; Western Australian Register of Developmental Anomalies, 374 Bagot Road, Subiaco, WA 6008, Australia.
authors.forename: Carol
authors.initials: C
authors.lastname: Bower
mesh_terms: D000328:Adult; D000932:Antiemetics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000013:Congenital Abnormalities / Q000453:epidemiology / Q000209:etiology; D005260:Female; D006801:Humans; D006939:Hyperemesis Gravidarum / Q000188:drug therapy; D007231:Infant, Newborn; D008297:Male; D048968:Morning Sickness / Q000188:drug therapy*; D056687:Off-Label Use; D017294:Ondansetron / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011261:Pregnancy Trimester, First; D012307:Risk Factors; D014904:Western Australia / Q000453:epidemiology
chemical_list: D000932:Antiemetics; D017294:Ondansetron