Abstract
Aims. 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.
Highlights
Nausea and vomiting of pregnancy (NVP) is the most common medical condition in pregnancy, affecting up to 85% of women [1]
hyperemesis gravidarum (HG) was recently reported to be associated with placental dysfunction disorders when it occurs in the second trimester [7]
The exposed pregnancies were all births in Western Australian (WA), 2002–2005, where the mother was dispensed ondansetron under the Australian Pharmaceutical Benefits Scheme (PBS)
Summary
Nausea and vomiting of pregnancy (NVP) is the most common medical condition in pregnancy, affecting up to 85% of women [1]. HG is identified by otherwise unexplained intractable vomiting and dehydration. It is usually associated with weight loss of more than 5% of prepregnancy weight, electrolyte imbalance, and ketonuria [5]. In Western Australia’s main hospital for women, the clinical guidelines for the management of HG with medications include ondansetron as a second line drug therapy, in cases of more refractory vomiting, with failure to improve on first line therapy with antiemetics, pyridoxine, antihistamines and vitamins, and recurrent hospital admissions [1]
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