Yusuf Cem Kaplan1, Jonathan Luke Richardson2, Elif Keskin-Arslan1, Hilal Erol-Coskun1, Debra Kennedy3. 1. Terafar - Izmir Katip Celebi University Teratology Information, Training and Research Center, Izmir, Turkey; Izmir Katip Celebi University School of Medicine, Department of Pharmacology Izmir, Turkey. 2. The UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK. Electronic address: Jonathan.Richardson@nuth.nhs.uk. 3. Mothersafe, The Royal Hospital for Women, Sydney, New South Wales, Australia; School of Women's and Children's Health University of New South Wales, Australia.
Abstract
AIMS: To investigate whether ondansetron use during pregnancy is associated with increased rates of major or subgroups of malformations. METHODS: PubMed/MEDLINE, Cochrane and Reprotox® databases were searched. Observational studies comprising an exposed and control group (healthy and/or disease-matched) were included. RESULTS: No significant increased risk for major malformations, heart defects, orofacial clefts, genitourinary malformations or hypospadias were identified in our primary analysis. A significant heterogeneity existed for isolated cleft palate. Elevated point estimates and altered statistical significances were present for some of the outcomes among secondary analyses. CONCLUSIONS: Ondansetron use during pregnancy was not associated with a significant increase in rate of major or selected subgroups of malformations in our primary analysis. However, results of the secondary analyses warrant the need for continued surveillance. These results may be reassuring for pregnant women in whom ondansetron use is clinically indicated since the absolute risks of possible concerns appear to be low.
AIMS: To investigate whether ondansetron use during pregnancy is associated with increased rates of major or subgroups of malformations. METHODS: PubMed/MEDLINE, Cochrane and Reprotox® databases were searched. Observational studies comprising an exposed and control group (healthy and/or disease-matched) were included. RESULTS: No significant increased risk for major malformations, heart defects, orofacial clefts, genitourinary malformations or hypospadias were identified in our primary analysis. A significant heterogeneity existed for isolated cleft palate. Elevated point estimates and altered statistical significances were present for some of the outcomes among secondary analyses. CONCLUSIONS:Ondansetron use during pregnancy was not associated with a significant increase in rate of major or selected subgroups of malformations in our primary analysis. However, results of the secondary analyses warrant the need for continued surveillance. These results may be reassuring for pregnant women in whom ondansetron use is clinically indicated since the absolute risks of possible concerns appear to be low.
Authors: Caitlin R Dean; Hyke Bierma; Ria Clarke; Brian Cleary; Patricia Ellis; Roger Gadsby; Norah Gauw; Karen Lodge; Kimber MacGibbon; Marian McBride; Deirdre Munro; Catherine Nelson-Piercy; Margaret O'Hara; Helen Penny; Katherine Shorter; René Spijker; Jone Trovik; Emma Watford; Rebecca C Painter Journal: BMJ Open Date: 2021-01-15 Impact factor: 2.692