Charité Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Augustenburger Platz 1, 13353, Berlin, Germany.
Arch Womens Ment Health. 2018 Dec;21(6):657-662. doi: 10.1007/s00737-018-0828-z. Epub 2018 Mar 22.
Schizophrenic or schizoaffective disorders often occur in early adulthood and thus affect women of childbearing age. For paliperidone information about reproductive safety is wanting. Therefore, we evaluated data from the German Embryotox pharmacovigilance institute regarding paliperidone therapy during pregnancy. The German Embryotox pharmacovigilance institute offers risk assessment on drug use in pregnancy and documents the outcome of more than 3500 drug-exposed pregnancies per year. In our study, we analyze the outcome of all pregnancies with paliperidone exposure, which have been assessed by our institute between January 2007 and June 2016. Of the 17 prospectively assessed pregnancies, 14 resulted in 15 live-born children (including one pair of twins). None of the infants presented with major congenital malformations. There were two spontaneous abortions at gestational weeks 6 and 11, respectively, and one elective termination due to personal reasons. Sixty-five percent of the pregnant women smoked cigarettes throughout pregnancy, 17% consumed alcohol. Five children were born prematurely (< 37 gestational weeks) and four were small for gestational age, each group including the twins. The results of our study suggest that paliperidone may be administered during pregnancy. The increased rate of prematurity and small for gestational age children can at least partially be explained by other risk factors. Psychiatric and obstetric close monitoring as well as additional medical and social support are recommended to ensure a healthy pregnancy course in patients with a severe mental illness.
精神分裂症或分裂情感性障碍通常在成年早期发生，因此影响到育龄妇女。关于帕利哌酮的生殖安全性信息尚缺乏。因此，我们评估了德国胚胎毒物学药物警戒研究所关于妊娠期帕利哌酮治疗的数据。德国胚胎毒物学药物警戒研究所提供妊娠期间药物使用的风险评估，并记录每年超过 3500 例药物暴露妊娠的结局。在我们的研究中，我们分析了我们研究所 2007 年 1 月至 2016 年 6 月期间评估的所有暴露于帕利哌酮的妊娠结局。在 17 例前瞻性评估的妊娠中，有 14 例妊娠结局为 15 例活产儿（包括一对双胞胎）。没有婴儿出现主要先天性畸形。分别有 2 例自然流产发生在妊娠第 6 周和第 11 周，1 例因个人原因选择性终止妊娠。65%的孕妇在整个孕期吸烟，17%的孕妇饮酒。有 5 名婴儿早产（<37 孕周），4 名婴儿小于胎龄，每个组都包括双胞胎。我们的研究结果表明，帕利哌酮可在妊娠期使用。早产和小于胎龄儿的发生率增加至少部分可以用其他危险因素来解释。建议对患有严重精神疾病的患者进行精神科和产科密切监测，以及额外的医疗和社会支持，以确保健康的妊娠过程。
