(245) Benefit-Risk Assessment of Herbal Medicines Used During Pregnancy and Lactation: A Descriptive Study of Registered Herbal Medicines in Bulgaria

Background: Despite being considered natural, herbal medicines may pose risks, especially during pregnancy and breastfeeding, as their safety profile is often not available or incomplete. The pharmacological effects of herbal medicines derive from different biologically active compounds, potentially leading to adverse effects or interactions with commonly prescribed and nonprescription medicines.

Objectives: This study aims to analyze the Summaries of Product Characteristics (SmPCs) of registered nonprescription herbal medicines in Bulgaria, focusing on information regarding safety during pregnancy and lactation.

Methods: The list of registered nonprescription medicines in Bulgaria, as of January 24th, 2024, was obtained from the Bulgarian Drug Agency's (BDA) website and analyzed. Herbal medicines were identified from the list, and their respective SmPCs were investigated. Data concerning the effects on human fertility, usage in women of childbearing potential, and specific recommendations for use during pregnancy and breastfeeding were extracted and evaluated.

Results: A total of 92 nonprescription herbal medicines were included in the BDA list as of January 24th, 2024. Among these, 44.57% were contraindicated (not recommended) for use during pregnancy and breastfeeding, 51.08% lacked sufficient information, and only 4.35% were allowed to be used in these special populations.

Conclusions: The majority of registered herbal medicines lack comprehensive safety information for pregnancy and breastfeeding. This knowledge gap may contribute to the inappropriate use of these products by pregnant and lactating women and perpetuate the misconception of their absolute safety.