| 1. |
- Danielsson, Bengt, et al.
(author)
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Use of ondansetron during pregnancy and congenital malformations in the infant.
- 2014
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In: Reproductive Toxicology. - : Elsevier BV. - 1873-1708 .- 0890-6238. ; 50, s. 134-137
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Journal article (peer-reviewed)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. |
- Hollmén, Jaakko, et al.
(author)
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Exploring epistaxis as an adverse effect of anti-thrombotic drugs and outdoor temperature
- 2018
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In: Proceedings of the 11th PErvasive Technologies Related to Assistive Environments Conference (PETRA). - New York, NY, USA : Association for Computing Machinery (ACM). - 9781450363907 ; , s. 1-4
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Conference paper (peer-reviewed)abstract
- Electronic health records contain a wealth of epidemiological information about diseases at the population level. Using a database of medical diagnoses and drug prescriptions in electronic health records, we investigate the correlation between outdoor temperature and the incidence of epistaxis over time for two groups of patients. One group consists of patients that had been diagnosed with epistaxis and also been prescribed at least one of the three anti-thrombotic agents: Warfarin, Apixaban, or Rivaroxaban. The other group consists of patients that had been diagnosed with epistaxis and not been prescribed any of the three anti-thrombotic drugs. We find a strong negative correlation between the incidence of epistaxis and outdoor temperature for the group that had not been prescribed any of the three anti-thrombotic drugs, while there is a weaker correlation between incidence of epistaxis and outdoor temperature for the other group. It is, however, clear that both groups are affected in a similar way, such that the incidence of epistaxis increases with colder temperatures.
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| 3. |
- Källén, Bengt, et al.
(author)
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Maternal hypothyroidism in early pregnancy and infant structural congenital malformations.
- 2014
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In: Journal of Thyroid Research. - : Hindawi Limited. - 2090-8067 .- 2042-0072. ; 2014:Mar 12
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Journal article (peer-reviewed)abstract
- Background. The question is debated on whether maternal hypothyroidism or use of thyroxin in early pregnancy affects the risk for infant congenital malformations. Objectives. To expand the previously published study on maternal thyroxin use in early pregnancy and the risk for congenital malformations. Methods. Data from the Swedish Medical Birth Register were used for the years 1996-2011 and infant malformations were identified from national health registers. Women with preexisting diabetes or reporting the use of thyreostatics, anticonvulsants, or antihypertensives were excluded from analysis. Risk estimates were made as odds ratios (ORs) or risk ratios (RRs) after adjustment for year of delivery, maternal age, parity, smoking, and body mass index. Results. Among 23 259 infants whose mothers in early pregnancy used thyroxin, 730 had a major malformation; among all 1 567 736 infants, 48012 had such malformations. The adjusted OR was 1.06 (95% CI 0.98-1.14). For anal atresia the RR was 1.85 (95% CI 1.00-1.85) and for choanal atresia 3.14 (95% CI 1.26-6.47). The risk of some other malformations was also increased but statistical significance was not reached. Conclusions. Treated maternal hypothyroidism may be a weak risk factor for infant congenital malformations but an association with a few rare conditions is possible.
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| 4. |
- Wikner, Birgitta Norstedt, et al.
(author)
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Are Hypnotic Benzodiazepine Receptor Agonists Teratogenic in Humans?
- 2011
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In: Journal of Clinical Psychopharmacology. - 0271-0749. ; 31:3, s. 356-359
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Journal article (peer-reviewed)abstract
- BACKGROUND:: Hypnotic benzodiazepine receptor agonists (HBRAs; zolpidem, zopiclone, and zaleplon) are used in the treatment of insomnia. Little is known about the safety of HBRAs during pregnancy. METHODS:: Data from the Swedish Medical Birth Registry from July 1, 1995, up to 2007 were used to identify 1318 women who reported the use of HBRAs in early pregnancy. They gave birth to 1341 infants. Maternal characteristics and the presence of congenital malformations were compared with all other women who gave birth (n = 1,106,001) and all other infants (n = 1,125,734) born during the study period. RESULTS:: Use and/or reporting of HBRAs increased with maternal age and were higher at first than higher parity. Maternal smoking was strongly associated with reported use of HBRAs. The probability of using HBRAs increased in women who had had 3 or more earlier miscarriages or 5 or more years of involuntary childlessness. An excess use of other drugs and above all psychoactive drugs were seen in women reporting use of HBRAs.Hypnotic benzodiazepine receptor agonists were not associated with an increased risk for congenital malformations. A statistically significant high risk for other intestinal malformations than atresias/stenosis was based on only 4 infants. CONCLUSIONS:: Maternal use of HBRAs does not seem to increase malformation risk. The tentative association with some intestinal malformations may be due to chance because of multiple testing and needs confirmation.
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| 5. |
- Wikner, Birgitta Norstedt, et al.
(author)
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Maternal use of thyroid hormones in pregnancy and neonatal outcome
- 2008
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In: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 1600-0412 .- 0001-6349. ; 87:6, s. 617-627
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Journal article (peer-reviewed)abstract
- Objective. To describe neonatal outcome including the presence of congenital malformations in infants born to women substituted with thyroid hormones, and the maternal characteristics of these women. Design. Register study based on prospectively collected data in relation to delivery. Setting. Swedish Health Registers. Population. All pregnant women (n = 848,468) and all infants born (n = 861,989) in Sweden from 1 July 1995 to 31 December 2004. Methods. Women who reported the use of thyroid hormones in early pregnancy or obtained a prescription for thyroid hormones later in pregnancy (n = 9,866), as well as their infants (n = 10,055) were identified from the Swedish Medical Birth Register. The reference population consisted of all women giving birth and their offspring during the same time interval. Main outcome measures. Neonatal outcome, malformations and maternal characteristics. Data were analyzed with adjustments for identified confounders. Results. Women using thyroxine had an increased rate of pre-eclampsia, diabetes (pre-existing or gestational), cesarean sections and inductions of labour compared to women in the reference population. The risk for preterm birth was marginally increased (OR 1.13, 95% CI 1.03-1.25). Neonatal thyroid disease was found in eight infants (seven with thyreotoxicosis and one unspecified), the expected number was 0.2. No further anomalies in neonatal diagnoses were found. A small but statistically significant risk for congenital malformations (OR = 1.14, 95% CI 1.05-1.26) was found. Conclusion. Women on thyroid substitution during pregnancy had an increased risk for some pregnancy complications, but their infants were only slightly affected.
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| 6. |
- Wikner, Birgitta Norstedt
(author)
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Register-based studies of delivery outcome after maternal use of some common drugs
- 2008
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Doctoral thesis (other academic/artistic)abstract
- This thesis aimed to study neonatal outcome including the presence of congenital malformations and to describe maternal characteristics for women using some common drugs during pregnancy. Drugs used in one benign condition (nausea and vomiting) and one chronic disease (hypothyroidism) and the CNS-active drugs benzodiazepines and hypnotic benzodiazepine receptor agonists were selected. The studies were based on the Swedish Medical Birth Register (MBR). The main advantages with MBR are that relatively large numbers of exposed women and their infants can be identified (coverage 98- 99% of deliveries in Sweden). Drug exposure as well as information about putative confounders are based on information retrieved early in pregnancy, before the birth of the child, and are therefore prospective. The information on the outcome is based on medical documents and is basically not affected by the exposure. Some weaknesses in MBR are that interview data will probably understate drug use, drugs may be taken but not reported/recorded, the indication for drug use is often not known and the information of exact duration and dosage is often incomplete. Further, the studies are based on born infants, aborted foetuses are not included. Pregnant women exposed to antiemetic drugs, a surrogate marker for nausea and vomiting during pregnancy, showed an overall better neonatal outcome including prevalence at birth of malformations in the infants. For some antiemetic drugs the number of exposures was low. Young maternal age, non-smoking, low education, parity >=2, were characteristics of women exposed to antiemetic drugs. There was an excess of girls and twins among born infants. Women using benzodiazepines or hypnotic benzodiazepine receptor agonists during pregnancy differ in many aspects from non-users. These differences may act as confounders in the analysis of pregnancy outcome, and were adjusted for. An increased risk for preterm birth, low birth weight and when exposed late during pregnancy also an increased risk for respiratory problems was seen in neonates. The teratogenic potential does not appear to be strong, but a higher than expected number of infants with pylorostenosis or alimentary tract atresia (especially small gut) was found. No increased risk for orofacial clefts was found. Women substituted with thyroid hormones during pregnancy had diabetes co-morbidity more often than expected as well as co-medication with, e.g., cardiovascular drugs, systemic corticosteroids and psychiatric drugs. Subfertility, previous miscarriage, pre-eclampsia, caesarean section and induction of labour were more common than in non-users. Neonates were only slightly affected, although a marginal increased risk for premature birth, increased rates of neonatal thyroid disease and a slightly increased rate of malformations was found. In conclusion, the Swedish Medical Birth Register has advantages and disadvantages but is a powerful tool for surveillance and assessment of teratogenic risks. However, possible associations found are hypothesis generating and need to be confirmed or rejected in new studies.
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| 7. |
- Wikner, Birgitta Norstedt, et al.
(author)
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Use of benzodiazepines and benzodiazepine receptor agonists during pregnancy: maternal characteristics
- 2007
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In: Pharmacoepidemiology and Drug Safety. - : Wiley. - 1053-8569 .- 1099-1557. ; 16:9, s. 988-994
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Journal article (peer-reviewed)abstract
- Background Use of benzodiazepine (BZD) drugs or hypnotic benzodiazepine receptor agonists (HBRAs) during pregnancy may represent a hazard for the foetus. In order to analyse this in an adequate way, knowledge of maternal characteristics as putative confounders is needed. Methods In the Swedish Medical Birth Register, 2149 pregnant women using BZDs or HBRAs were identified, 1944 of them in early pregnancy. These women were compared with other women (n = 859 455) giving births during the same period (1 July 1995-31 December 2004). The following maternal characteristics were studied: age, parity, smoking habits, education, previous miscarriages, years of involuntary childlessness as an estimate of subfertility, concomitant drug use and some pregnancy complications. Results Use and/or reporting of BZDs or HBRAs increased with maternal age. It was higher at first and 4+ parity and increased markedly with maternal smoking. Women with low education reported a higher use than women with high education. Previous miscarriage or subfertility had little impact on the use of these drugs. Preterm birth and caesarean section (also at term birth) were more common than expected. In women using BZDs or HBRAs, other types of psychoactive drugs were used in excess. Conclusions Women using BZDs or HBRAs differ in many aspects from women not using those drugs. These differences may act as confounders in the analysis of pregnancy outcome.
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| 8. |
- Wikner, Birgitta Norstedt, et al.
(author)
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Use of benzodiazepines and benzodiazepine receptor agonists during pregnancy: neonatal outcome and congenital malformations
- 2007
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In: Pharmacoepidemiology and Drug Safety. - : Wiley. - 1053-8569 .- 1099-1557. ; 16:11, s. 1203-1210
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Journal article (peer-reviewed)abstract
- Background Exposure to Benzodiazepines (BZD) during foetal life has been suggested to contribute to neonatal morbidity and some congenital malformations, for example, orofacial clefts. Here we aimed to study the neonatal outcome and congenital malformations in neonates whose mothers reported use of BZD and/or hypnotic benzodiazepine receptor agonists (HBRA) during pregnancy. Methods In the Swedish Medical Birth Register we identified 1979 infants whose mothers (n = 1944) reported use of BZD and/or HBRA in early pregnancy. An additional 401 infants were studied, born to 390 mothers who were prescribed such drugs during late pregnancy. Neonatal outcome including congenital malformations after exposure was compared with that of all births (n = 873 879). Results An increased risk for preterm birth and low birth weight was detected in the exposed population. The rate of relatively major congenital malformations was moderately increased among infants exposed in early pregnancy (adjusted OR = 1.24, 95%CI 1.00-1.55), not explained by known teratogenic maternal co-medication. A higher than expected number of infants with pylorostenosis or alimentary tract atresia (especially small gut) was found. This was, however, based on only seven infants for each group of malformation without association to any specific BZD or HBRA. The earlier proposed increased risk for orofacial clefts was not confirmed in our study. Conclusions Maternal use of BZD and/or HBRA may increase the risk for preterm birth and low birth weight and cause neonatal symptoms, but does not appear to have a strong teratogenic potential. The tentative association with pylorostenosis and alimentary tract atresia needs confirmation. Copyright (C) 2007 John Wiley & Sons, Ltd.
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