Teratogenicity in Pharmacovigilance

Introduction

Teratogenicity is one of the most important safety considerations in pharmacovigilance because exposure to certain medicinal products during pregnancy may result in congenital malformations, developmental abnormalities, fetal death or other adverse pregnancy outcomes. The identification, evaluation and communication of teratogenic risks influence medicinal product development, regulatory decision-making, clinical practice and post-authorisation pharmacovigilance activities throughout the product lifecycle.

Understanding teratogenicity requires integration of developmental biology, reproductive toxicology, clinical pharmacology, epidemiology and pharmacovigilance. Evidence regarding teratogenic potential evolves over time through non-clinical studies, clinical development, spontaneous adverse event reporting, pregnancy exposure monitoring, pregnancy registries, pharmacoepidemiological research and post-authorisation safety studies.

This article explains the biological principles of teratogenicity, mechanisms of drug-induced congenital anomalies, methods used to evaluate reproductive risks, regulatory expectations and the role of pharmacovigilance in protecting patients and potential pregnancies.

Learning Objectives

After reading this article you should be able to:

• define teratogenicity and distinguish it from other forms of reproductive toxicity;
• explain the biological mechanisms underlying congenital malformations;
• understand critical periods of embryonic and fetal development;
• interpret sources of teratogenicity evidence;
• describe regulatory expectations for medicines with reproductive risks;
• understand pharmacovigilance activities supporting reproductive safety;
• explain the relationship between teratogenicity and Pregnancy Prevention Programmes.