BACKGROUND:A significant number of women of childbearing age have schizophrenia or other psychoses. This means that there is a considerable risk of in utero exposure to risperidone due to maternal use. OBJECTIVE:To determine whether in utero exposure to the atypical antipsychotic risperidone is associated with poor pregnancy and fetal/neonatal outcomes. METHODS:A search of the Benefit Risk Management Worldwide Safety database, using a selection of preferred terms from the Medical Dictionary of Regulatory Activities, was performed to identify all cases of pregnancy or fetal/neonatal outcomes reported in association with risperidone treatment from its first market launch (international birth date, 1 June 1993) to 31 December 2004. The main measures were the patterns and reporting rates of pregnancy (stillbirth and spontaneous and induced abortion) and fetal/neonatal outcomes (congenital abnormalities, perinatal syndromes and withdrawal symptoms) for women administered risperidone during pregnancy. RESULTS:Overall, 713 pregnancies were identified in women who were receiving risperidone. Data were considered prospective in 516 of these, and retrospective in the remaining 197 cases. The majority of the known adverse pregnancy and fetal/neonatal outcomes were retrospectively reported. Of the 68 prospectively reported pregnancies with a known outcome, organ malformations and spontaneous abortions occurred 3.8% and 16.9% (when the 15 induced abortions were excluded from the denominator, as they were predominantly undertaken for nonmedical reasons), respectively, a finding consistent with background rates of the general population. There were 12 retrospectively reported pregnancies involving major organ malformations, the most frequently reported of which affected the heart, brain, lip and/or palate. There were 37 retrospectively reported pregnancies involving perinatal syndromes, of which 21 cases involved behavioural or motor disorders. In particular, there was a cluster of cases reporting tremor, jitteriness, irritability, feeding problems and somnolence, which may represent a withdrawal-emergent syndrome. CONCLUSION:This comprehensive review of the Benefit Risk Management Worldwide Safety database for case reports of risperidone exposure during pregnancy represents the largest ever published dataset documenting pregnancy outcomes for women taking the atypical antipsychotic risperidone. It indicates that in utero exposure to risperidone does not appear to increase the risk of spontaneous abortions, structural malformations and fetal teratogenic risk above that of the general population. Self-limited extrapyramidal effects in neonates were observed after maternal exposure to risperidone during the third trimester of pregnancy. Risperidone should only be used during pregnancy if the benefits outweigh the potential risks.

译文

背景:许多育龄妇女患有精神分裂症或其他精神病。这意味着由于母体使用,子宫内存在利培酮的相当大的风险。
目的:确定宫内暴露于非典型抗精神病药物利培酮是否与不良妊娠和胎儿/新生儿结局有关。
方法:使用“监管活动医学词典”中的一些首选术语,对“全球利益风险管理全球安全性”数据库进行搜索,以识别首次上市时与利培酮治疗相关的所有妊娠或胎儿/新生儿结局病例发射(国际出生日期,1993年6月1日)至2004年12月31日。主要测量指标为:妇女在怀孕期间服用利培酮。
结果:总体上,接受利培酮治疗的女性中有713例怀孕。其中516例被认为是前瞻性数据,其余197例被视为回顾性数据。回顾性报告了大多数已知的不良妊娠和胎儿/新生儿结局。在68例结果已知的妊娠报告中,器官畸形和自然流产发生率分别为3.8%和16.9%(当15例人工流产因非医学原因而被排除在分母时),这一发现与普通人群的本底率。回顾性报告了12例妊娠,涉及主要器官畸形,其中最常报告的妊娠累及心脏,大脑,嘴唇和/或上颚。回顾性报告了37例涉及围产期综合征的妊娠,其中21例涉及行为或运动障碍。特别是,有一系列报告震颤,发抖,易怒,进食问题和嗜睡的病例,这可能代表戒断综合征。
结论:这份对全球利益风险管理全球安全性数据库的全面审查,包括妊娠期间服用利培酮的病例报告,是有史以来出版量最大的数据集,记录了服用非典型抗精神病药利培酮的妇女的妊娠结局。这表明子宫内暴露于利培酮的行为似乎并未增加自发流产,结构畸形和胎儿致畸风险的风险,超过了一般人群。孕妇在孕晚期暴露于利培酮后,在新生儿中出现了自我限制的锥体外系作用。如果利培酮的益处大于潜在的风险,则应仅在妊娠期间使用利培酮。

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