The anti-nausea medication domperidone, which had previously been contraindicated for pregnant women, had its contraindication lifted in April 2025 by the Ministry of Health Japan, Labour and Welfare’s advisory board. As a result, on May 20th, the “pregnancy” item was removed from the list of contraindications in its package insert.
According to the Japan National Center for Child Health and Development’s “Pregnancy and Medicine Information Centre”, which handles medication consultations during pregnancy, the most common inquiry related to drugs contraindicated in pregnancy from 2005 to 2022 was about domperidone. Domperidone is mainly used to treat nausea associated with chronic gastritis, but many women later realised they were pregnant after taking the medication for what was actually morning sickness, leading to anxiety.
The centre analysed these consultation cases and reported that there was no significant difference in the incidence of birth defects between those who took domperidone and those who did not. Therefore, it concluded that “even if domperidone is administered during early pregnancy, the likelihood of it increasing the risk of congenital abnormalities is low.” It was also confirmed that in countries like the UK, Canada and Germany, domperidone is not contraindicated for pregnant women.
It is a positive development that anxiety among pregnant women who took domperidone before realising they were pregnant has been alleviated. However, it is important to note that morning sickness is not an approved indication for domperidone.
To ensure the benefits of stabilising a pregnant woman’s condition through appropriate medication are not compromised, it is crucial not to start or stop taking medications on one’s own during pregnancy, but to always consult a doctor.
此前被列为孕妇禁忌药物的止吐药多潘立酮(domperidone),在2025年4月的日本厚生劳动省审议会上被批准解除禁忌,5月20日,其说明书中的“孕妇禁忌”项被正式删除。
据国立成育医疗研究中心的“妊娠与药物信息中心”介绍,从2005年到2022年,关于孕妇禁忌药物的咨询中,最多的是关于多潘立酮的。多潘立酮主要用于治疗与慢性胃炎相关的恶心等症状,但许多孕妇是在服药后才发现自己怀孕的,原来实际症状是妊娠反应(孕吐),因此感到不安。
该中心调查了这些咨询案例,并指出,在服用与未服用多潘立酮的情况下,先天异常的发生率没有显著差异。因此得出结论:即使在妊娠初期使用多潘立酮,也不会显著增加胎儿先天异常的风险。此外,还确认如英国、加拿大、德国等国家的药品说明书中,并未将其列为孕妇禁忌。
对于在得知怀孕前服用了多潘立酮的孕妇而言,这一禁忌解除能够缓解她们的担忧是件好事。然而,需要特别注意的是,多潘立酮并不是治疗孕吐的适应症。
为了不损害通过合理用药来稳定孕妇身体状况的益处,在怀孕期间不应自行决定服药或停药,务必咨询医生。