The field of drug safety in the perinatal period is of paramount importance due to the increasing use of medications during pregnancy and postpartum. Women with acute or chronic conditions, as well as those experiencing pregnancy- or breastfeeding-related disorders, often require pharmacological interventions. However, the exclusion of pregnant and lactating women from clinical trials has resulted in a significant gap in research concerning drug exposure during this critical period. This lack of data leads to uncertainty about the safety of medications for both mothers and their offspring. Historical tragedies, such as those involving thalidomide and diethylstilbestrol, underscore the necessity of prioritizing medication safety in the perinatal period to prevent future disasters. Recent concerns with drugs like valproate and topiramate further highlight the ongoing challenges in identifying teratogens in a timely manner. The perinatal period, spanning from conception to one year after birth, is particularly vulnerable to harmful exposures, necessitating comprehensive research to safeguard maternal and child health.

This research topic aims to publish insights related to the safety aspects of various medications, including vaccines, biologicals, and other innovative therapies, used during the perinatal period. The objective is to address critical questions regarding the identification of teratogens, the protection of newborns from teratogenic risks, and the provision of reliable information to healthcare professionals and patients. By exploring these areas, the research seeks to enhance understanding and inform safer pharmacotherapy practices for pregnant and lactating women.

To gather further insights in the realm of drug safety during the perinatal period, we welcome articles addressing, but not limited to, the following themes:

• Preclinical and clinical research on medication safety
• Post-marketing surveillance and real-world evidence
• Regulations and policies related to maternal and fetal pharmacotherapy
• In vitro studies and placenta-perfusion models
• Clinical lactation studies
• Real-world data from pregnancy registries and electronic health records
• Population-based cohort studies and pharmacokinetic modeling
Infant follow-up studies and policy-oriented research

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Frontiers in Drug Safety and Regulation

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