Use of ondansetron during pregnancy and congenital malformations in the infant.
(2014) In Reproductive Toxicology 50. p.134-137- 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... (More)
- 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. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/4913288
- author
- Danielsson, Bengt ; Wikner, Birgitta Norstedt and Källén, Bengt LU
- organization
- publishing date
- 2014
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Reproductive Toxicology
- volume
- 50
- pages
- 134 - 137
- publisher
- Elsevier
- external identifiers
-
- pmid:25450422
- wos:000346459900017
- scopus:84918502695
- pmid:25450422
- ISSN
- 1873-1708
- DOI
- 10.1016/j.reprotox.2014.10.017
- language
- English
- LU publication?
- yes
- id
- 2d77b1af-fbcf-4674-bfa0-a5f921296701 (old id 4913288)
- alternative location
- http://www.ncbi.nlm.nih.gov/pubmed/25450422?dopt=Abstract
- date added to LUP
- 2016-04-01 10:10:24
- date last changed
- 2022-04-19 23:24:06
@article{2d77b1af-fbcf-4674-bfa0-a5f921296701,
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.}},
author = {{Danielsson, Bengt and Wikner, Birgitta Norstedt and Källén, Bengt}},
issn = {{1873-1708}},
language = {{eng}},
pages = {{134--137}},
publisher = {{Elsevier}},
series = {{Reproductive Toxicology}},
title = {{Use of ondansetron during pregnancy and congenital malformations in the infant.}},
url = {{http://dx.doi.org/10.1016/j.reprotox.2014.10.017}},
doi = {{10.1016/j.reprotox.2014.10.017}},
volume = {{50}},
year = {{2014}},
}