Kamath Priyanka, Kamath Ashwin, Ullal Sheetal D
Department of Pharmacology, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India - 575001.
World J Hepatol. 2021 Jul 27;13(7):747-762. doi: 10.4254/wjh.v13.i7.747.
Drug use during pregnancy is not common. Drug-induced liver injury (DILI) is a potential complication that is rare but can adversely affect both the mother and the fetus. Although many drugs can directly cause hepatotoxicity, idiosyncratic liver injury is common in pregnancy. Underreporting of adverse drug reactions, lack of adequate literature regarding drug safety in pregnancy, and the inherent difficulty in diagnosing DILI during pregnancy make the management of this condition challenging. This review attempts to describe the existing literature regarding DILI in pregnancy, which is mainly in the form of case reports; several studies have looked at the safety of antithyroid drugs, antiretroviral drugs, and paracetamol, which have an indication for use in pregnancy; the relevant data from these studies with regard to DILI has been presented. In addition, the review describes the diagnosis of DILI, grading the disease severity, assessment of causality linking the drug to the adverse event, regulatory guidelines for evaluating the potential of drugs to cause liver injury, efforts to ensure better participation of women in clinical trials and studies in pregnant women population in particular, and the challenges involved in generating adequate research evidence. The establishment of DILI registries in various countries is an encouraging development; however, there is a need for promoting active, spontaneous reporting of adverse events during pregnancy to ensure rapid generation of evidence regarding the safety of a drug in pregnant women.
孕期用药并不常见。药物性肝损伤（DILI）是一种潜在并发症，虽罕见但可对母亲和胎儿产生不利影响。尽管许多药物可直接导致肝毒性，但特异质性肝损伤在孕期很常见。药物不良反应报告不足、缺乏关于孕期药物安全性的充分文献以及孕期诊断DILI存在固有困难，使得这种情况的管理具有挑战性。本综述试图描述关于孕期DILI的现有文献，其主要形式为病例报告；有几项研究探讨了抗甲状腺药物、抗逆转录病毒药物和对乙酰氨基酚在孕期使用的安全性，本文呈现了这些研究中与DILI相关的数据。此外，综述还描述了DILI的诊断、疾病严重程度分级、药物与不良事件因果关系的评估、评估药物导致肝损伤可能性的监管指南、确保女性更好地参与临床试验尤其是孕妇群体研究的努力以及生成充分研究证据所涉及的挑战。各国建立DILI登记处是一个令人鼓舞的进展；然而，需要促进孕期不良事件的主动、自发报告，以确保快速生成关于药物在孕妇中安全性的证据。
