B Källén1, H Rydhstroem, A Aberg. 1. Tornblad Institute, and the Department of Obstetrics and Gynecology, University of Lund, Sweden. embryol@embryol.lu.se
Abstract
OBJECTIVE: To study possible teratogenic risks with the use of an inhaled glucocorticoid, budesonide, in early pregnancy. METHODS: Using the Swedish Medical Birth Registry, congenital malformations were studied in 2014 infants whose mothers had used inhaled budesonide for asthma in early pregnancy. The presence of congenital malformations was checked further with auxiliary registries. RESULTS: No increase in the general rate of congenital malformations was observed: 3.8% (95% confidence interval [CI] 2.9, 4.6) of the infants had a congenital malformation diagnosed, which is similar to the population rate (3.5%). After exposure to budesonide, four infants were born with orofacial clefts; this also is similar to the expected number (3.3). CONCLUSION: Even though a specific teratogenic effect of use of budesonide in early pregnancy cannot be ruled out, it is unlikely that a clinically significant teratogenic risk exists.
OBJECTIVE: To study possible teratogenic risks with the use of an inhaled glucocorticoid, budesonide, in early pregnancy. METHODS: Using the Swedish Medical Birth Registry, congenital malformations were studied in 2014 infants whose mothers had used inhaled budesonide for asthma in early pregnancy. The presence of congenital malformations was checked further with auxiliary registries. RESULTS: No increase in the general rate of congenital malformations was observed: 3.8% (95% confidence interval [CI] 2.9, 4.6) of the infants had a congenital malformation diagnosed, which is similar to the population rate (3.5%). After exposure to budesonide, four infants were born with orofacial clefts; this also is similar to the expected number (3.3). CONCLUSION: Even though a specific teratogenic effect of use of budesonide in early pregnancy cannot be ruled out, it is unlikely that a clinically significant teratogenic risk exists.
Authors: Jørn Olsen; Andrew Czeizel; Henrik Toft Sørensen; Gunnar Lauge Nielsen; Lolkje T W de Jong van den Berg; Lorentz M Irgens; Charlotte Olesen; Lars Pedersen; Helle Larsen; Rolv T Lie; Corinne S de Vries; Ulf Bergman Journal: Drug Saf Date: 2002 Impact factor: 5.606
Authors: R Caprilli; M A Gassull; J C Escher; G Moser; P Munkholm; A Forbes; D W Hommes; H Lochs; E Angelucci; A Cocco; B Vucelic; H Hildebrand; S Kolacek; L Riis; M Lukas; R de Franchis; M Hamilton; G Jantschek; P Michetti; C O'Morain; M M Anwar; J L Freitas; I A Mouzas; F Baert; R Mitchell; C J Hawkey Journal: Gut Date: 2006-03 Impact factor: 23.059