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Use of ondansetron during pregnancy and congenital malformations in the infant.

Danielsson, Bengt; Wikner, Birgitta Norstedt and Källén, Bengt LU (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)
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author
organization
publishing date
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
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
2015-01-06 10:58:31
date last changed
2017-10-22 03:08:55
@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},
  volume       = {50},
  year         = {2014},
}