Delayed Hypersensitivity Reactions Caused by Drug Excipients: A Literature Review

Area of Science:

• Pharmacology
• Clinical Allergy
• Drug Formulation

Background:

• Excipients, defined by the European Medicines Agency (EMA), are non-active components of pharmaceutical products.
• Delayed hypersensitivity reactions (DHRs) to drug excipients have been documented, but their prevalence remains unquantified.
• Allergic reactions to excipients can manifest with varying severity, from cutaneous issues to life-threatening systemic responses.

Purpose of the Study:

• To conduct a comprehensive literature review on allergies to pharmaceutical excipients.
• To document reported DHRs associated with specific medication types and their excipients.
• To identify excipients most frequently implicated in DHRs for different drug classes.

Main Methods:

• Systematic literature search for reported cases of DHRs attributed to pharmaceutical excipients.
• Classification of reported cases by medication type and implicated excipient.
• Alphabetical sorting of cases to facilitate identification of common excipient-medication associations.

Main Results:

• The review compiled documented instances of DHRs linked to pharmaceutical excipients.
• A categorized list of medications and their associated excipients causing DHRs was generated.
• Analysis aimed to highlight excipients with higher reported frequencies of DHRs within specific drug formulations.

Conclusions:

• Pharmaceutical excipients can elicit delayed hypersensitivity reactions with diverse clinical presentations.
• Further research is needed to establish the prevalence of DHRs caused by drug excipients.
• Identifying frequently implicated excipients may aid in risk assessment and formulation development.