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Background <p>The European Medicines Agency has recommended a series of restrictions on the use of sodium valproate (valproate) following research linking its exposure in utero to adverse congenital and neurodevelopmental effects in offspring. Recent research has highlighted a potential increased risk of neurodevelopmental disorders in children born to males taking valproate prior to conception. Clinicians and patients require guidance regarding suitable alternatives.</p> Aim <p>To provide an overview of suitable alternatives to valproate in the management of bipolar disorder.</p> Method <p>A narrative review was conducted. Only medications with an established evidence base in managing different phases of bipolar disorder and endorsed within clinical practice guidelines were considered. Eligible guidelines included those (i) where recommendations were informed by a formal guideline development process and (ii) published in English within the last 15&#xa0;years. REPROTOX® was chosen as the primary information source regarding reproductive safety of alternative medications.</p> Results <p>Of all second-generation antipsychotics, quetiapine should be considered a first-line alternative to valproate. Lithium has been associated with an increased risk of cardiac malformations, especially Ebstein anomaly, following in utero exposure. However, given its robust efficacy as an antimanic agent and the absolute risk of cardiac abnormalities being low, it’s use can still be considered in individuals of child-bearing potential with appropriate monitoring. Carbamazepine treatment should be avoided due to concerns for teratogenicity. Although considered safe in pregnancy, lamotrigine is largely effective at preventing relapse of bipolar depression. Thus, lamotrigine offers limited clinical utility as an alternative to valproate.</p> Conclusion <p>Specific recommendations are made regarding alternatives to valproate in managing bipolar disorder.</p>

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Comparative efficacy and safety of alternatives to sodium valproate in the management of bipolar affective disorder in people of child-bearing age: a narrative review by the European Society of Clinical Pharmacy’s mental health specialist interest group

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年4月28日

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  • Ita Fitzgerald,
  • Izgi Bayraktar,
  • Birgit Eiden,
  • Rosalind Gittins,
  • Erica Magni,
  • Marie Humbert-Claude,
  • Lara-Turiya Molitschnig,
  • Paula Darm,
  • Anna Waksmundzka-Walczuk,
  • Nikolaus Riesenhuber,
  • Matej Stuhec,
  • Ivana Tašková,
  • Martina Hahn

摘要

Background

The European Medicines Agency has recommended a series of restrictions on the use of sodium valproate (valproate) following research linking its exposure in utero to adverse congenital and neurodevelopmental effects in offspring. Recent research has highlighted a potential increased risk of neurodevelopmental disorders in children born to males taking valproate prior to conception. Clinicians and patients require guidance regarding suitable alternatives.

Aim

To provide an overview of suitable alternatives to valproate in the management of bipolar disorder.

Method

A narrative review was conducted. Only medications with an established evidence base in managing different phases of bipolar disorder and endorsed within clinical practice guidelines were considered. Eligible guidelines included those (i) where recommendations were informed by a formal guideline development process and (ii) published in English within the last 15 years. REPROTOX® was chosen as the primary information source regarding reproductive safety of alternative medications.

Results

Of all second-generation antipsychotics, quetiapine should be considered a first-line alternative to valproate. Lithium has been associated with an increased risk of cardiac malformations, especially Ebstein anomaly, following in utero exposure. However, given its robust efficacy as an antimanic agent and the absolute risk of cardiac abnormalities being low, it’s use can still be considered in individuals of child-bearing potential with appropriate monitoring. Carbamazepine treatment should be avoided due to concerns for teratogenicity. Although considered safe in pregnancy, lamotrigine is largely effective at preventing relapse of bipolar depression. Thus, lamotrigine offers limited clinical utility as an alternative to valproate.

Conclusion

Specific recommendations are made regarding alternatives to valproate in managing bipolar disorder.