Abstract

"PHARMACEUTICAL ASSESSMENT FOR MATERNAL AND NEONATAL SAFETY: DRUG MONITORING IN PREGNANCY AND LACTATION"

Sachin Saini, Nikita Kaushik*, Parveen Kumari, Sushila

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Abstract

Pharmacovigilance in pregnant and lactating women is a crucial yet often underrepresented area in drug safety surveillance. Due to physiological changes during pregnancy and the potential transfer of drugs to the fetus or infant, this population is at increased risk for adverse drug reactions. Traditional clinical trials rarely include pregnant or breastfeeding women, resulting in limited safety data. However, recent advancements such as the use of real-world evidence, artificial intelligence, and physiologically based pharmacokinetic modeling are helping to bridge these knowledge gaps. Strengthening pregnancy exposure registries, promoting patient-centred reporting tools, and encouraging ethical inclusion of these populations in research are vital steps forward. A collaborative global approach, supported by regulatory reforms and technological innovation, is essential to ensure the safe and effective use of medications for mothers and their children. Ultimately, improved pharmacovigilance will lead to better clinical decisions and health outcomes for this vulnerable group.

Keywords: Adverse drug effect, lactation, teratogenic, pharmacovigilance, foetus, breastfeeding, pregnancy.