title: The safety of liposome bupivacaine, a novel local analgesic formulation.
abstract: OBJECTIVE
  Pooled safety data from 10 randomized, double-blind studies of liposome bupivacaine, a novel local analgesic formulation, were examined.
  
  
  METHODS
  Eight hundred twenty-three patients received liposome bupivacaine (dose, 66 to 532 mg) given locally at the surgical site in 5 different settings (hemorrhoidectomy, bunionectomy, breast augmentation, total knee arthroplasty, and hernia repair); 446 received bupivacaine HCl (dose, 75 to 200 mg) and 190 received placebo. Adverse events (AEs) were monitored for up to 36 days after administration.
  
  
  RESULTS
  Overall, 48% of patients were men and 21% were 65 years and older. Incidence of AEs was 62% for patients receiving liposome bupivacaine, versus 75% and 43% for patients receiving bupivacaine HCl and placebo, respectively. The most common AEs (incidence >10%) in the liposome bupivacaine arms were nausea, constipation, and vomiting. One death was reported in the liposome bupivacaine group and 1 in the bupivacaine HCl group; both deemed unrelated to study drug. Serious AEs were reported in 2.7% of patients receiving liposome bupivacaine, versus 5.4% and 1.1% of those receiving bupivacaine HCl and placebo, respectively. In both the liposome bupivacaine and bupivacaine HCl groups, 6% of patients experienced a cardiac AE; these were primarily tachycardia (4% vs. 5%, respectively) and bradycardia (2% vs. 1%, respectively). Overall incidence of treatment-related cardiac AEs was <1%; all were associated with liposome bupivacaine. All of these events were assessed by investigators as possibly related to study drug; all were mild or moderate in severity, and none required therapeutic intervention.
  
  
  CONCLUSIONS
  Liposome bupivacaine exhibited acceptable tolerability across 823 patient exposures.
authors: *Department of Anesthesiology, Thomas Jefferson University, Philadelphia, PA †Department of Anesthesiology, Yale School of Medicine, New Haven, CT ‡Pacira Pharmaceuticals, Inc., Parsippany, NJ §Rebecca and John Moores Cancer Center, La Jolla, CA.
authors: Eugene R
authors: ER
authors: Viscusi
authors: Raymond
authors: R
authors: Sinatra
authors: Erol
authors: E
authors: Onel
authors: Sonia L
authors: SL
authors: Ramamoorthy
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D001145:Arrhythmias, Cardiac / Q000139:chemically induced / Q000453:epidemiology; D002045:Bupivacaine / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy*; D010149:Postoperative Pain / Q000188:drug therapy; D012737:Sex Factors
chemical_list: D000779:Anesthetics, Local; D008081:Liposomes; D002045:Bupivacaine