Introduction

Favipiravir has gained attention during the Coronavirus Disease-2019 pandemic due to its potential antiviral effect against Severe Acute Respiratory Syndrome Coronavirus-2. Favipiravir has been identified as a teratogen in animal studies, but there is limited human data. We aimed to evaluate the pregnancy outcomes of women exposed to favipiravir during the pandemic.

Material and methods

Pregnant women who were exposed to favipiravir and applied to Marmara University School of Medicine Medical Pharmacology Outpatient Clinic Teratology Information Service between December 2020-September 2021 are included in the study. The demographic information, medical and obstetric histories of patients were acquired during admission, the outcomes of the pregnancies and the characteristics of the infants were gathered by regular phone calls. The infants whose parents consented were evaluated by a pediatrician for general well-being and congenital anomalies.

Results

22 pregnant women were included in this study. 81.8 % received the recommended favipiravir dose (8000 mg in 5 days), in the first trimester. Two patients were lost to follow-up, there was one elective termination and 19 live births. Congenital anomalies were found in 2 infants, one of whom had 9q34 duplication syndrome. Except for these, all newborns examined by the pediatrician were healthy.

Discussion

Within a limited case series, a subset of the infants exposed to favipiravir prenatally were followed up to 1 year of age. Two infants exhibited congenital malformations that cannot be directly linked to favipiravir due to confounding variables. Considering the limited data published, favipiravir does not appear to be a major teratogen.

中文翻译：

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法匹拉韦似乎不是主要致畸剂：来自土耳其的病例系列

介绍

法匹拉韦在 2019 年冠状病毒大流行期间因其对严重急性呼吸系统综合症冠状病毒 2 的潜在抗病毒作用而受到关注。法匹拉韦在动物研究中已被确定为致畸剂，但人类数据有限。我们的目的是评估大流行期间接触法匹拉韦的女性的妊娠结局。

材料与方法

该研究纳入了2020年12月至2021年9月期间接触过法匹拉韦并向马尔马拉大学医学院医学药理学门诊畸胎学信息服务中心申请的孕妇。患者的人口统计信息、医疗和产科史是在入院期间获得的，妊娠结果和婴儿的特征是通过定期电话收集的。儿科医生对经父母同意的婴儿进行了总体健康状况和先天异常情况的评估。

结果

本研究纳入了 22 名孕妇。81.8% 在妊娠早期接受了推荐的法匹拉韦剂量（5 天内 8000 毫克）。2 例患者失访，1 例选择性终止妊娠，19 例活产。2 名婴儿发现先天性异常，其中 1 名患有 9q34 重复综合征。除此之外，经儿科医生检查的所有新生儿均健康。

讨论

在有限的病例系列中，对一部分产前接触法匹拉韦的婴儿进行了随访直至 1 岁。由于混杂变量，两名婴儿表现出先天性畸形，无法与法匹拉韦直接相关。考虑到已发表的有限数据，法匹拉韦似乎不是主要致畸剂。