Department of Medical Science, Warren Alpert Medical School, Brown University, Providence, Rhode Island.
Obstet Gynecol. 2022 Sep 1;140(3):408-411. doi: 10.1097/AOG.0000000000004893. Epub 2022 Aug 3.
Within several years after receiving U.S. Food and Drug Administration (FDA) approval in the late 1970s, valproate was shown to increase the risk for major congenital malformations and learning disabilities in the offspring of women who used the drug during pregnancy. Nonetheless, its use in pregnant women has persisted for more than four decades, recently resulting in numerous lawsuits and, in countries other than the United States, criminal indictments of the manufacturers of valproate. The use of valproate in pregnancy persisted and extended beyond its original indication for the treatment of epilepsy. Several recent studies indicate that the drug is more often prescribed to treat pregnant women with bipolar depression and migraine than for seizure control. Especially concerning is the absence of valproate from the list of more than 60 drugs for which the FDA has implemented Risk Evaluation and Mitigation Strategies to prevent or limit untoward consequences associated with specific drugs. Until this step is taken, avoidance of the teratogenic effects of valproate will rely on the vigilance of those caring for women and people with the potential to get pregnant.
在 20 世纪 70 年代末获得美国食品和药物管理局 (FDA) 批准后的几年内，已证明丙戊酸会增加女性在怀孕期间使用该药物后所生孩子出现重大先天畸形和学习障碍的风险。尽管如此，丙戊酸在孕妇中的使用已经持续了四十多年，最近导致了许多诉讼，并且在除美国以外的其他国家，丙戊酸的制造商也受到了刑事起诉。丙戊酸在怀孕期间的使用持续存在，并超出了其最初用于治疗癫痫的适应症。最近的几项研究表明，该药物更常被开给患有双相情感障碍和偏头痛的孕妇，而不是用于控制癫痫发作。特别令人担忧的是，丙戊酸并未被列入 FDA 实施风险评估和缓解策略以预防或限制与特定药物相关的不良后果的 60 多种药物清单中。在采取这一步骤之前，避免丙戊酸的致畸作用将依赖于照顾妇女和有怀孕可能的人的警惕性。
