欧洲药品管理局 (European Medicines Agency, EMA) 加强了避免在妊娠期使用丙戊酸类药物的措施
2018 年 3 月，EMA 出台了更强有力的措施，旨在避免婴儿在子宫内暴露于丙戊酸药物。根据这一新的限制，由于胎儿先天畸形和出现发育问题的风险高，因此在妊娠期禁止将丙戊酸药物用于治疗双相情感障碍。除非已实施妊娠预防计划并且符合特定的条件，否则丙戊酸药物不得用于育龄期女性患者。其中包括：
评估患者妊娠的可能性
根据需要在开始治疗之前以及治疗期间进行妊娠试验
咨询丙戊酸治疗的风险以及整个治疗过程中有效避孕的必要性
由专科医师对正在应用的治疗方法进行每年至少一次的回顾审查
一份在每次此类年度审查中患者和处方医师都会详细检查的风险确认书，以确认已给出并理解恰当的建议。
EMA 表示，由于有证据显示，丙戊酸在妊娠期使用的风险信息仍然没有传达给女性（尽管采取了早期措施来确保这一点），因此已实施新的措施。
参见:治疗步骤 参见:治疗流程 参见:患者指导小结
定义
病史和查体
诊断性检查
治疗流程
贡献者
作者 查看所有
Professor
Department of Psychiatry
Dalhousie University
Sun Life Financial Chair in Adolescent Mental Health
IWK Health Centre and Dalhousie University
Director
WHO Collaborating Center for Mental Health Training and Policy
Dalhousie University
Halifax
Nova Scotia
Canada
利益冲突披露
SK has received research grants from various foundations and national granting agencies (none from either the pharmaceutical nor psychotherapy industries) to support some of his academic work. He is employed by a university and hospital, and sees patients who sometimes present with a suicide attempt. He has also co-authored a textbook on suicide risk assessment and management, published in 2007 and the second edition in 2012.Dr Stan Kutcher would like to gratefully acknowledge Dr Magdalena Szumilas, a previous contributor to this monograph. MS is an author of a reference cited in this topic.
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Professor of Psychiatry and Mental Health
Departamento de Saude Mental
Faculdade de Ciencias Medicas
Universidade Nova de Lisboa
Lisbon
Portugal
利益冲突披露
RG declares that he has no competing interests.Assistant Clinical Professor of Psychiatry
University of California
San Diego
Veterans Hospital
La Jolla
CA
利益冲突披露
SR declares that he has no competing interests.
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