| 1. |
- Danielsson, Bengt, et al.
(författare)
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Use of ondansetron during pregnancy and congenital malformations in the infant.
- 2014
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Ingår i: Reproductive Toxicology. - : Elsevier BV. - 1873-1708 .- 0890-6238. ; 50, s. 134-137
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Tidskriftsartikel (refereegranskat)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.
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| 2. |
- Källén, Bengt, et al.
(författare)
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Fetal safety of erythromycin. An update of Swedish data.
- 2014
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Ingår i: European Journal of Clinical Pharmacology. - : Springer Science and Business Media LLC. - 1432-1041 .- 0031-6970. ; 70:3, s. 355-360
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Tidskriftsartikel (refereegranskat)abstract
- In previous studies from the Swedish Medical Birth Register, a possible association between erythromycin therapy and an increased risk for cardiovascular defects was found. Other studies using different methodology have not verified this observation. The finding resulted in a warning for the use of erythromycin in early pregnancy, followed by a marked decline in such use. The present study was conducted to follow up on the previous observations and to find methodological explanations for the variation in results in these different published studies.
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| 3. |
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| 4. |
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| 5. |
- Källén, Karin, et al.
(författare)
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Relation between oculo-auriculo-vertebral (OAV) dysplasia and three other non-random associations of malformations (VATER, CHARGE, and OEIS).
- 2004
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Ingår i: American Journal of Medical Genetics. Part A. - : Wiley. - 1552-4825 .- 1552-4833. ; 127A:1, s. 26-34
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Tidskriftsartikel (refereegranskat)abstract
- Using a statistical methodology, we aimed to identify a group of probable cases of oculo-auriculo-vertebral (OAV) dysplasia and to investigate possible relationships between different patterns of congenital malformations. Among 5,260 infants with multiple malformations collected from 4 large registers of congenital malformations, we identified 312 probable OAV cases. With the same technique, we have earlier defined epidemiological delineations of three other well-known non-random associations of congenital malformations (CHARGE, VATER, and OEIS). We found convincing relationships between OAV and VATER or CHARGE but none between OAV and OEIS or between the three malformation complexes CHARGE, VATER, and OEIS. An association between two conditions indicates similarities in pathogenesis or in etiology. We suggest that the connection between OAV and CHARGE could be related to a common pathogenetic mechanism: disturbed neural crest development. (C) 2003 Wiley-Liss, Inc.
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| 6. |
- Källén, Karin, et al.
(författare)
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VATER non-random association of congenital malformations: study based on data from four malformation registers
- 2001
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Ingår i: American Journal of Medical Genetics. - : Wiley. - 0148-7299 .- 1096-8628. ; 101:1, s. 26-32
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Tidskriftsartikel (refereegranskat)abstract
- This study was undertaken to find a strict, unbiased epidemiological delineation of the VATER non-random association of congenital malformations and, based on registry information, to identify a group of probable VATER association infants suitable for etiological analyses. Information on 5,260 infants with multiple malformations was collected from four large registers of congenital malformations. Data were analyzed using a statistical method in which various putative confounders were controlled for. Our results indicate the existence of a distinct group of malformations corresponding to the VATER association: esophageal atresia, anal atresia, upper preaxial limb reduction defects, and costo-vertebral malformations. A subdivision into an upper and a lower group of VATER association was indicated, with heart malformations associated with the upper group and kidney malformations associated with the lower group. Restricting the inclusion criteria for VATER association to the above mentioned core malformations, few infants seem to belong to the VATER association, thus limiting the possibilities of carrying out etiological analyses. A relatively large number of infants may belong to a family of related conditions among which VATER association is a subgroup. In the search for risk factors, a strict definition of the VATER association is needed in order to not dilute the study material with irrelevant cases. The present study provides such strict inclusion criteria.
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| 7. |
- Almgren, Malin, et al.
(författare)
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Population-based study of antiepileptic drug exposure in utero-Influence on head circumference in newborns
- 2009
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Ingår i: Seizure. - : Elsevier BV. - 1532-2688 .- 1059-1311. ; 18:10, s. 672-675
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To study the effect of AED exposure on head circumference in the newborn. Methods: Data on all Swedish singletons births between 1995 and 2005, over 900,000 births, were obtained from the Swedish Medical Birth Registry. The effects of AEDs on birth-weight-adjusted mean head circumference (bw-adj-HC) were estimated by comparison with data from all births in an analysis which was adjusted for year of birth, maternal age, parity, maternal smoking, and maternal body mass index. Results: A significant reduction of mean bw-adj-HC was seen after both carbamazepine (CBZ) (standard deviation scores (SDS) = 0.15, p < 0.001) and valproic acid (VPA) (SDS = 0.10, p = 0.04) in monotherapy. No effect on mean bw-adj-HC was seen for phenytoin, clonazepam, lamotrigine and gabapentin. There was a significant increase in the occurrence of microcephaly (bw-adj-HC smaller than 2 SD below the mean) after any AED polytherapy (OR = 2.85, 95% CI: 1.74-4.78) but not after AED monotherapy or monotherapy with CBZ or VPA. CBZ OF VPA was taken by 71% of the pregnant mothers on AED, and the usage increased over time. Conclusions: CBZ and VPA in monotherapy during pregnancy reduce mean bw-adj-HC. AED polytherapy increases the rate of microcephaly but no significant effect is seen of AED monotherapy. The possible significance for the further development of the child is uncertain but should be explored. (C) 2009 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
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| 8. |
- Asker, C, et al.
(författare)
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Use of antiemetic drugs during pregnancy in Sweden
- 2005
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Ingår i: European Journal of Clinical Pharmacology. - : Springer Science and Business Media LLC. - 1432-1041 .- 0031-6970. ; 61:12, s. 899-906
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Tidskriftsartikel (refereegranskat)abstract
- Background: More than one-half of all pregnant women suffer from nausea and vomiting during pregnancy (NVP), primarily during the first trimester. Methods: Prospectively ascertained information on drug use during pregnancy was obtained from the Swedish Medical Birth Register during the period July 1, 1995 to 2002. Antiemetics (antiemetic antihistamines, dopamine modulators, and ondansetron) primarily used for NVP were studied, and women reporting the use of these drugs were compared with all women who gave birth during the study period. Results: Use of these antiemetics was reported in 4.5% of the pregnant women - 86% of whom reported their use before the first antenatal visit (usually weeks 10-12). Meclozine, followed by other antihistamines, accounted for 68% of the drugs reported. Young maternal age, multiparity, non-smoking, and a period of unwanted childlessness increased the probability of using any of the antiemetics during pregnancy. Women with a low education used these drugs more often than women with a relatively higher education. Neonates born to women who used any of the antiemetics had a reduced risk for low birthweight, prematurity, being small-for-gestational age, and having a malformation. No specific differences were observed with respect to the outcome following a comparison of different antiemetic drugs. Conclusions: Women using antiemetics as a rule have a better delivery outcome than other women, probably due to an effect of a well-functioning placenta, which is associated with NVP. There were no signs of any significant teratogenicity of the drugs studied, but for some drugs the number of exposures was low.
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| 9. |
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| 10. |
- Aspberg, Sara, et al.
(författare)
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Confirmed association between neonatal phototherapy or neonatal icterus and risk of childhood asthma
- 2010
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Ingår i: Pediatric Allergy and Immunology. - : Wiley. - 0905-6157 .- 1399-3038. ; 21:4, s. 733-739
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Tidskriftsartikel (refereegranskat)abstract
- We have previously demonstrated an association between neonatal phototherapy and/or neonatal icterus and risk of hospitalization for childhood asthma. This study included children who were prescribed anti-asthmatic medication on a population basis to study exposures during the foetal and neonatal period and risk of childhood asthma. The Swedish Medical Birth Register was linked to the Swedish Prescribed Drug Register. Perinatal data for singleton children who were prescribed anti-asthmatic medication (n = 61 256) were compared with corresponding data for all singleton children born in Sweden from 1 January 1990 to 30 June 2003 and surviving to 1 July 2005 (n = 1 338 319). Mantel-Haenszel's odds ratios were calculated after adjustment for various known confounders. Being the first-born child, maternal age above 44 yr, involuntary childlessness for more than 1 yr, maternal smoking during pregnancy, maternal diabetes mellitus of any kind, pre-eclampsia, caesarean section, and instrumental vaginal delivery were all associated with an increased prescription of anti-asthmatic medication during childhood. Preterm birth, low birth weight, being small for gestational age, respiratory problems, mechanical ventilation, and sepsis and/or pneumonia were also associated with increased drug prescriptions. Neonatal phototherapy and/or icterus were risk determinants for children who developed asthma before the age of 12. After controlling for confounders, the odds ratio for phototherapy and/or icterus remained at 1.30 (95% confidence interval 1.16-1.47). In conclusion, this large population-based study confirms an association between some maternal and perinatal factors and childhood asthma, including neonatal phototherapy and/or icterus.
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