Symptoms Associated With Gadolinium Exposure: Different Patterns and Rates Between Linear and Macrocyclic...

Area of Science:

• Pharmacovigilance
• Radiology
• Contrast Media Safety

Background:

• Patients receiving multiple gadolinium-based contrast agent (GBCA) administrations may experience symptoms associated with gadolinium exposure (SAGE).
• Understanding the safety profiles of different GBCA types is crucial for clinical practice.

Purpose of the Study:

• To analyze pharmacovigilance data on SAGE patterns associated with linear and macrocyclic GBCAs.
• To compare the incidence and types of SAGE symptoms between linear and macrocyclic GBCAs.

Main Methods:

• Utilized FDA Adverse Event Reporting System (FAERS) data from 2014-2019.
• Analyzed SAGE preferred terms (PTs) for 3 linear and 3 macrocyclic GBCAs in patients with 3+ SAGE symptoms.
• Calculated SAGE weights and analyzed 3-PT combinations, comparing with iodinated contrast media.

Main Results:

• Linear GBCAs had significantly higher SAGE weights (20%-24%) than macrocyclic GBCAs (5%-9%).
• Prevalent 3-PT combinations for linear GBCAs occurred 152-164 times, versus 1-13 for macrocyclic GBCAs.
• Identified distinct SAGE patterns for different GBCA types; common symptoms included pain, arthralgia, and headache.

Conclusions:

• Macrocyclic GBCAs demonstrate a significantly lower SAGE burden compared to linear GBCAs.
• SAGE occurrence with macrocyclic GBCAs was comparable to iodinated contrast media, suggesting potential negligibility.
• Further research and routine pharmacovigilance are warranted to establish causality.