'Harmful' or 'excipients of concern'? Rethinking terminology and risk in pediatric excipients.

Abstract

Introduction: Excipients, though often overshadowed by active pharmaceutical ingredients, are essential for the successful formulation of medicinal products. They serve critical roles, such as enhancing drug stability, ensuring proper delivery, and facilitating patient compliance. However, the perception of excipients has become increasingly polarized, with some being labeled as 'Harmful' or 'Dangerous' without a thorough and balanced analysis of contributing factors.

Areas covered: This commentary seeks to address this growing concern. A targeted PubMed and Embase literature search was conducted for relevant publications that categorize excipients as dangerous, often without consideration of contextual factors like patient age group, dosage form, disease severity, and exposure levels to the excipients in question. This blanket labeling, instead of providing a well-rounded analysis of risk-versus-benefit and safety data for the pediatric population, may spread fear rather than help clinicians make informed decisions. By analyzing the methodologies and assumptions underlying these studies, this commentary highlights the gaps and biases that may lead to miscommunication and unwarranted fear in the healthcare community.

Expert opinion: Shifting from terms such as 'harmful,' 'hazardous,' or 'dangerous' to 'excipients of concern' reflects a more balanced, evidence-based approach. It recognizes the complexities of excipient use, enabling informed decisions prioritizing safety and efficacy.