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Expert Opin Drug Saf · Jun 2018
Local anesthetics systemic toxicity association with exparel (bupivacaine liposome)- a pharmacovigilance evaluation.
- Nitish Aggarwal.
- a Ohio State University Wexner Medical Center , Columbus , OH , USA.
- Expert Opin Drug Saf. 2018 Jun 1; 17 (6): 581-587.
BackgroundLocal 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.MethodsAdverse 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.ResultsA 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]).ConclusionThe 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.
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