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Effects of maternal modafinil treatment on fetal development and neonatal growth parameters — a multicenter case series of the European Network of Teratology Information Services (ENTIS).

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Title: Effects of maternal modafinil treatment on fetal development and neonatal growth parameters — a multicenter case series of the European Network of Teratology Information Services (ENTIS).
Authors: Onken, Marlies (AUTHOR), Lohse, Lukas (AUTHOR), Coulm, Bénédicte (AUTHOR), Beghin, Delphine (AUTHOR), Richardson, Jonathan L. (AUTHOR), Bermejo‐Sánchez, Eva (AUTHOR), Aguilera, Cristina (AUTHOR), Bosch, Montserrat (AUTHOR), Cassina, Matteo (AUTHOR), Chouchana, Laurent (AUTHOR), De Santis, Marco (AUTHOR), Duman, Mine Kadioglu (AUTHOR), Gören, M. Zafer (AUTHOR), Johnson, Diana (AUTHOR), Bera, Annie Pierre Jonville (AUTHOR), Kaplan, Yusuf C. (AUTHOR), Kennedy, Debra (AUTHOR), Kwok, Susan (AUTHOR), Lacroix, Isabelle (AUTHOR), Lepelley, Marion (AUTHOR)
Source: Acta Psychiatrica Scandinavica. Nov2024, Vol. 150 Issue 5, p372-384. 13p.
Subjects: Abortion, Pregnancy outcomes, Miscarriage, First trimester of pregnancy, Weight in infancy
Abstract: Objective: In recent years, safety concerns about modafinil exposure during pregnancy have emerged. In particular, increased risks for major congenital anomalies (MCA) and impaired fetal growth were reported, although study results were conflicting. Our investigation aims to examine previously reported safety signals. Method: Multicenter case series based on data from 18 Teratology Information Services from 12 countries. Modafinil exposed pregnancies with an estimated date of birth before August 2019 were included in this study. For prospectively ascertained pregnancies, cumulative incidences of pregnancy outcomes, rate of nonchromosomal MCA in first trimester exposed pregnancies and percentiles of neonatal/infant weight and head circumference (HC) were calculated. Potential dose‐dependent effects on fetal growth were explored by linear regression models. Retrospectively ascertained cases were screened for pattern of MCA and other adverse events. Results: One hundred and seventy‐five prospectively ascertained cases were included, of which 173 were exposed at least during the first trimester. Cumulative incidences for live birth, spontaneous abortion and elective termination of pregnancy were 76.9% (95% CI, 68.0%–84.8%), 9.3% (95% CI, 5.0%–16.9%), and 13.9% (95% CI, 8.1%–23.1%), respectively. Nonchromosomal MCA was present in 3/150 live births, corresponding to an MCA rate of 2.0% (95%CI, 0.6%–6.1%), none were reported in pregnancy losses. Compared to reference standards, birth weight (BW) tended to be lower and neonatal HC to be smaller in exposed newborns (data available for 144 and 73 of 153 live births, respectively). In nonadjusted linear regression models, each 100 mg increase of average dosage per pregnancy day was associated with a decrease in standard deviation score (SDS) of −0.28 SDS (95% CI, −0.45 to −0.10) for BW and of −0.28 SDS (95% CI, −0.56 to 0.01) for HC. Screening of 22 retrospectively reported cases did not reveal any specific pattern of MCA or other adverse outcomes. Conclusion: The results do not indicate an increased risk of MCA after in utero exposure to modafinil, but a tendency toward lower BW and reduced neonatal HC. However, these findings should be regarded as preliminary. Until further studies allow for a definite conclusion, modafinil should not be used during pregnancy. [ABSTRACT FROM AUTHOR]
Copyright of Acta Psychiatrica Scandinavica is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Effects of maternal modafinil treatment on fetal development and neonatal growth parameters — a multicenter case series of the European Network of Teratology Information Services (ENTIS).
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  Data: <searchLink fieldCode="AR" term="%22Onken%2C+Marlies%22">Onken, Marlies</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lohse%2C+Lukas%22">Lohse, Lukas</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Coulm%2C+Bénédicte%22">Coulm, Bénédicte</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Beghin%2C+Delphine%22">Beghin, Delphine</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Richardson%2C+Jonathan+L%2E%22">Richardson, Jonathan L.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bermejo‐Sánchez%2C+Eva%22">Bermejo‐Sánchez, Eva</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Aguilera%2C+Cristina%22">Aguilera, Cristina</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bosch%2C+Montserrat%22">Bosch, Montserrat</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cassina%2C+Matteo%22">Cassina, Matteo</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Chouchana%2C+Laurent%22">Chouchana, Laurent</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22De+Santis%2C+Marco%22">De Santis, Marco</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Duman%2C+Mine+Kadioglu%22">Duman, Mine Kadioglu</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gören%2C+M%2E+Zafer%22">Gören, M. Zafer</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Johnson%2C+Diana%22">Johnson, Diana</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bera%2C+Annie+Pierre+Jonville%22">Bera, Annie Pierre Jonville</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kaplan%2C+Yusuf+C%2E%22">Kaplan, Yusuf C.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kennedy%2C+Debra%22">Kennedy, Debra</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kwok%2C+Susan%22">Kwok, Susan</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lacroix%2C+Isabelle%22">Lacroix, Isabelle</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lepelley%2C+Marion%22">Lepelley, Marion</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Acta+Psychiatrica+Scandinavica%22">Acta Psychiatrica Scandinavica</searchLink>. Nov2024, Vol. 150 Issue 5, p372-384. 13p.
– Name: Subject
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  Data: <searchLink fieldCode="DE" term="%22Abortion%22">Abortion</searchLink><br /><searchLink fieldCode="DE" term="%22Pregnancy+outcomes%22">Pregnancy outcomes</searchLink><br /><searchLink fieldCode="DE" term="%22Miscarriage%22">Miscarriage</searchLink><br /><searchLink fieldCode="DE" term="%22First+trimester+of+pregnancy%22">First trimester of pregnancy</searchLink><br /><searchLink fieldCode="DE" term="%22Weight+in+infancy%22">Weight in infancy</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Objective: In recent years, safety concerns about modafinil exposure during pregnancy have emerged. In particular, increased risks for major congenital anomalies (MCA) and impaired fetal growth were reported, although study results were conflicting. Our investigation aims to examine previously reported safety signals. Method: Multicenter case series based on data from 18 Teratology Information Services from 12 countries. Modafinil exposed pregnancies with an estimated date of birth before August 2019 were included in this study. For prospectively ascertained pregnancies, cumulative incidences of pregnancy outcomes, rate of nonchromosomal MCA in first trimester exposed pregnancies and percentiles of neonatal/infant weight and head circumference (HC) were calculated. Potential dose‐dependent effects on fetal growth were explored by linear regression models. Retrospectively ascertained cases were screened for pattern of MCA and other adverse events. Results: One hundred and seventy‐five prospectively ascertained cases were included, of which 173 were exposed at least during the first trimester. Cumulative incidences for live birth, spontaneous abortion and elective termination of pregnancy were 76.9% (95% CI, 68.0%–84.8%), 9.3% (95% CI, 5.0%–16.9%), and 13.9% (95% CI, 8.1%–23.1%), respectively. Nonchromosomal MCA was present in 3/150 live births, corresponding to an MCA rate of 2.0% (95%CI, 0.6%–6.1%), none were reported in pregnancy losses. Compared to reference standards, birth weight (BW) tended to be lower and neonatal HC to be smaller in exposed newborns (data available for 144 and 73 of 153 live births, respectively). In nonadjusted linear regression models, each 100 mg increase of average dosage per pregnancy day was associated with a decrease in standard deviation score (SDS) of −0.28 SDS (95% CI, −0.45 to −0.10) for BW and of −0.28 SDS (95% CI, −0.56 to 0.01) for HC. Screening of 22 retrospectively reported cases did not reveal any specific pattern of MCA or other adverse outcomes. Conclusion: The results do not indicate an increased risk of MCA after in utero exposure to modafinil, but a tendency toward lower BW and reduced neonatal HC. However, these findings should be regarded as preliminary. Until further studies allow for a definite conclusion, modafinil should not be used during pregnancy. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Acta Psychiatrica Scandinavica is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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      – Type: doi
        Value: 10.1111/acps.13643
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      – Code: eng
        Text: English
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        PageCount: 13
        StartPage: 372
    Subjects:
      – SubjectFull: Abortion
        Type: general
      – SubjectFull: Pregnancy outcomes
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      – SubjectFull: Miscarriage
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      – SubjectFull: First trimester of pregnancy
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      – SubjectFull: Weight in infancy
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      – TitleFull: Effects of maternal modafinil treatment on fetal development and neonatal growth parameters — a multicenter case series of the European Network of Teratology Information Services (ENTIS).
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