What does real-world data reveal about cangrelor's safety? An analysis of FDA adverse event reporting system (FAERS) database.

Abstract

Background: Cangrelor is used to reduce thrombotic events in adults undergoing percutaneous coronary intervention, but real-world safety data is limited. This study analyzes adverse events (AEs) related to cangrelor using the FDA adverse event reporting system (FAERS) database.

Methods: We employed statistical techniques such as the reporting odds ratio, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker to analyze the data from the FAERS database.

Results: Out of a total of 15,011,506 case reports, 209 events were related to cangrelor. Thirty-one preferred term (PT) describing AEs were identified, affecting eight organ systems. The most reported PT was off-label use (n = 163). Several unexpected AEs not listed in the drug labeling emerged, including cardiac arrest, and cardiac failure. Although percutaneous coronary intervention was the most common indication (35.4%), numerous events were associated with off-label use, particularly for conditions such as acute myocardial infarction, antiplatelet therapy, and anticoagulant therapy.

Conclusion: Our research reveals both anticipated and unexpected AEs, providing important new information on the safety profile of cangrelor. Furthermore, we have discovered certain problems pertaining to product applications. It is recommended that manufacturers clearly highlight indications and usage instructions, and medical personnel closely follow drug administration protocols.