Real-World Pharmacovigilance Analysis of Adverse Events Associated with Liposomal Bupivacaine and Bupivacaine.

Abstract

Purpose: Liposomal bupivacaine, a novel formulation of bupivacaine, is increasingly employed for the long-lasting pain relief. The primary goal of this study was to conduct a thorough safety evaluation of liposomal bupivacaine and bupivacaine.

Patients and methods: This study analyzed adverse events (AEs) associated with liposomal bupivacaine and bupivacaine using the FDA Adverse Event Reporting System (FAERS) database from Q1 2004 to Q2 2024. Reports were screened for signal detection, focusing on the onset time and disproportionality analysis to identify positive safety signals. We evaluated the AEs associated with liposomal bupivacaine and bupivacaine. Then, we further categorized them according to the Important Medical Event Terms List (IME list).

Results: The analysis revealed 8,023 AE reports in total. Liposomal bupivacaine had 58 positive safety signals, 24 of which were off-label and listed in the IME list. These signals were primarily associated with cardiac (eg, cardiogenic shock), gastrointestinal (eg, paralytic ileus), and neurological disorders. Bupivacaine generated 107 safety signals, with 49 being off-label but also on the IME list. These signals mainly affected the fetus (eg, fetal bradycardia), respiratory system (eg, respiratory depression), and nervous system (eg, neurotoxicity).

Conclusion: This study identified unexpected AEs associated with liposomal bupivacaine and bupivacaine. Physicians must exercise particular caution when administering liposomal bupivacaine due to its associated risks. Monitoring for delayed analgesia-related AEs may enhance the safe use of this medication for pain management.