Hypersensitivity to Excipients in Drugs: An EAACI Position Paper

Area of Science:

• Pharmacology
• Allergy and Immunology
• Drug Development

Background:

• Excipients, inactive compounds in pharmaceuticals, can cause drug hypersensitivity reactions (DHR).
• Excipient-related DHR are frequently overlooked, potentially causing recurrent anaphylaxis to various medications.
• Identifying excipient hypersensitivity is vital for patient safety and effective treatment.

Purpose of the Study:

• To provide practical recommendations for suspecting, diagnosing, and managing excipient hypersensitivity.
• To highlight common culprit excipients implicated in DHR.
• To establish evidence-based guidelines for diagnostic testing of excipient allergies.

Main Methods:

• Extensive literature review on excipient hypersensitivity.
• Incorporation of collective expert experience where literature was limited.
• Analysis of product monographs to identify potential excipient triggers.
• Review of diagnostic testing strategies including skin, in vitro, and provocation tests.

Main Results:

• Excipient hypersensitivity should be suspected in patients with unexplained anaphylaxis to multiple unrelated drugs.
• Commonly implicated excipients include polyethylene glycol, methylcelluloses, gelatine, povidone, and mannitol.
• Diagnostic evaluation involves reviewing drug formulations and performing specific tests with pure excipients.

Conclusions:

• Accurate diagnosis and management of DHR require consideration of excipient involvement.
• Specific diagnostic approaches for excipient hypersensitivity are essential.
• Consensus-based recommendations for excipient-specific testing are provided to guide clinical practice.