- This meta-analysis suggests that ondansetron use during pregnancy is not associated with an increased rate of overall major congenital malformations, heart defects, orofacial clefts, genitourinary malformations and hypospadias.
Why this matters
- Current nausea and vomiting of pregnancy treatment guidelines suggest that ondansetron may be considered if first-line drugs fail to suppress maternal symptoms.
- Studies investigating the safety of maternal ondansetron use have reported inconsistent findings.
- Six studies involving 3914 ondansetron-exposed infants and 1,563,139 healthy control individuals met eligibility criteria after a search across electronic databases.
- Primary outcome: risk for overall major congenital malformations.
- Secondary outcome: risk for heart defects, orofacial clefts, isolated cleft palate, genitourinary malformations and hypospadias.
- Funding: None.
- Ondansetron use during pregnancy was not associated with a significantly increased risk for overall major congenital malformations vs control group (OR, 1.16; 95% CI, 0.92-1.45).
- Compared with the control group, ondansetron group did not show significant increased risk for:
- heart defects (OR, 1.26; 95% CI, 0.90-1.77);
- orofacial clefts (OR, 0.89; 95% CI, 0.32-2.50);
- isolated cleft palate (OR, 1.13; 95% CI, 0.43-2.97);
- genitourinary malformations (OR, 1.55; 95% CI, 0.89-2.69);
- hypospadias (OR, 1.61; 95% CI, 0.69-3.75).
- Majority of the studies did not report data on exposure time windows, dose and duration.
- Characteristics of the control groups widely differed between studies.