Local anesthetics systemic toxicity association with exparel (bupivacaine liposome)- a pharmacovigilance evaluation

Abstract

Background: Local anesthetic systemic toxicity (last) is a rare life threatening complication usually from intra-arterial or intravenous injection leading to systemic absorption of regional anesthesia drug. the objective of this research was to statistically quantify the association between exparel (bupivacaine liposome) injectable suspension and last.

Methods: Adverse Event Reporting System database of FDA, which houses public and industry submitted adverse event case reports, was queried and analyzed to quantify the passive pharmacovigilance signal for Local Anesthetic Systemic Toxicity as associated with use of bupivacaine Liposome.

Results: A dis-proportionality analysis of the signals yielded a significant association between Local Anesthetic Systemic Toxicity and Exparel. The Chi-Squared with Yates' correction was 596.66 and Proportional Reporting Ratio was 6.23 [95% CI: 5.41-7.18]).

Conclusion: The health care provider, including anesthetists, should be made aware that as with bupivacaine HCl, Local Anesthetic Systemic Toxicity, including seizures and cardiac arrest, could be induced by Exparel as well.

Keywords: Pharmacovigilance analysis; adverse events; bupivacaine liposomal; exparel.