Bhakta Janki, Bainbridge Jacquelyn, Borgelt Laura
University of Colorado Anschutz Medical Campus Skaggs School of Pharmacy and Pharmaceutical Sciences Aurora, CO, USA.
University of Colorado Anschutz Medical Campus Skaggs School of Pharmacy and Pharmaceutical Sciences Aurora, CO, USA.
Epilepsy Behav. 2015 Nov;52(Pt A):212-7. doi: 10.1016/j.yebeh.2015.08.004. Epub 2015 Nov 6.
Many antiepileptic drugs (AEDs) have the potential to cause teratogenicity. We evaluated eight antiepileptic drugs (AEDs) classified as Federal Drug Administration (FDA) pregnancy category D, X, or N designations and having documented teratogenic effects. These include carbamazepine, ethosuximide, fosphenytoin, phenobarbital, phenytoin, primidone, topiramate, and valproate. Women with epilepsy (WWE) may need one or more of these AEDs for seizure control but may be unaware of the potential teratogenicity associated with their use. In utero exposure to AEDs increases the risks for both congenital malformations and other teratogenic defects. Given that approximately 50% of pregnancies are unintended, it is likely that women with epilepsy taking these medications could unknowingly put a growing fetus at risk. For women using contraception while taking these medications, many choose combined hormonal contraceptives (CHCs). Drug-drug interactions exist between AEDs and CHCs that may decrease contraceptive efficacy. The aim of this study was to evaluate prescribing patterns for potentially teratogenic AEDs and contraceptive use in WWE of childbearing ability, including those with potential drug-drug interactions. This study also determined the number of WWE of childbearing ability prescribed potentially teratogenic AEDs and documentation of a pregnancy or contraception plan.
This was a retrospective, observational study of WWE age 15-44 years, of childbearing ability, prescribed an AED from July 1, 2011 to June 30, 2012, and who had an appointment at the University of Colorado Hospital Outpatient Neurology Clinic (Anschutz Medical Campus).
One hundred fifteen women with an average age of 30.7 years and various types of seizures were evaluated. The majority of patients were prescribed topiramate (34/115, 30%) or carbamazepine (27/115, 23%). Of the women, 30/115 (26%) had a documented contraception method when taking a potentially teratogenic AED. Of these women prescribed contraception, most (18/30, 60%) used an oral combined hormonal contraceptive or progestin-only pill, a majority of which had a potential for a drug-drug interaction with their AEDs (16/18, 89%). Less than 7% of women received counseling on a contraception plan, and 18% of subjects received counseling on a pregnancy plan.
Most WWE of childbearing ability taking potentially teratogenic AEDs were not using contraception. Those using contraception frequently had a method that has a significant drug-drug interaction which reduces the effectiveness of contraception. Women with epilepsy of childbearing ability prescribed an AED should be using effective contraception or participating in active discussions about pregnancy planning to avoid unplanned pregnancies and possible teratogenic effects of these AEDs. Documentation about pregnancy planning or contraceptive use in WWE of childbearing ability is minimal and should be discussed at least annually. It is critical for providers to discuss with WWE of childbearing ability the benefits and risks of various AED treatments; the need to select appropriate, effective contraception when pregnancy is not desired; and the importance of counseling regarding contraceptive or pregnancy planning.
许多抗癫痫药物（AEDs）具有致畸的可能性。我们评估了八种被美国食品药品监督管理局（FDA）列为妊娠D类、X类或N类且有明确致畸作用的抗癫痫药物。这些药物包括卡马西平、乙琥胺、磷苯妥英、苯巴比妥、苯妥英、扑米酮、托吡酯和丙戊酸盐。癫痫女性（WWE）可能需要一种或多种此类抗癫痫药物来控制癫痫发作，但可能并未意识到使用这些药物存在潜在的致畸性。子宫内暴露于抗癫痫药物会增加先天性畸形和其他致畸缺陷的风险。鉴于约50%的妊娠是意外妊娠，服用这些药物的癫痫女性很可能在不知情的情况下使发育中的胎儿面临风险。对于在服用这些药物期间使用避孕措施的女性，许多人选择复方激素避孕药（CHCs）。抗癫痫药物与复方激素避孕药之间存在药物相互作用，这可能会降低避孕效果。本研究的目的是评估育龄期癫痫女性中潜在致畸性抗癫痫药物的处方模式及避孕措施的使用情况，包括那些存在潜在药物相互作用的情况。本研究还确定了育龄期癫痫女性中开具潜在致畸性抗癫痫药物的人数以及妊娠或避孕计划的记录情况。
这是一项对年龄在15 - 44岁、具有生育能力、在2011年7月1日至2012年6月30日期间开具了抗癫痫药物且在科罗拉多大学医院门诊神经科诊所（安舒茨医学校区）就诊的癫痫女性进行的回顾性观察研究。
共评估了115名平均年龄为30.7岁、患有各种类型癫痫的女性。大多数患者被开具了托吡酯（34/115，30%）或卡马西平（27/115，23%）。在这些女性中，30/115（26%）在服用潜在致畸性抗癫痫药物时有记录在案的避孕方法。在这些开具了避孕措施的女性中，大多数（18/30，60%）使用口服复方激素避孕药或仅含孕激素的避孕药，其中大多数与她们的抗癫痫药物存在潜在的药物相互作用（16/18，89%）。不到7%的女性接受了避孕计划咨询，18%的受试者接受了妊娠计划咨询。
大多数服用潜在致畸性抗癫痫药物的育龄期癫痫女性未采取避孕措施。那些采取避孕措施的女性通常采用的方法存在显著的药物相互作用，会降低避孕效果。开具了抗癫痫药物的育龄期癫痫女性应采取有效的避孕措施或积极参与关于妊娠计划的讨论，以避免意外妊娠以及这些抗癫痫药物可能产生的致畸作用。关于育龄期癫痫女性妊娠计划或避孕措施使用情况的记录极少，应至少每年进行讨论。对于医疗服务提供者而言，与育龄期癫痫女性讨论各种抗癫痫治疗的益处和风险、在不希望妊娠时选择合适有效避孕措施的必要性以及避孕或妊娠计划咨询的重要性至关重要。
