Reports of death with use of propofol (Diprivan) for nonprocedural (long-term) sedation and literature review

Anesthesiology

Volumn 105, Issue 5, 2006, Pages 1047-1051

  Wysowski, Diane K ^a   Pollock, Martin L ^b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

LORAZEPAM; PROPOFOL;

ANESTHESIA; ARTICLE; BRADYCARDIA; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DOSE RESPONSE; DRUG DOSE REGIMEN; DRUG SAFETY; DRUG USE; EMULSION; FEMALE; FEVER; FOOD AND DRUG ADMINISTRATION; HEART ARREST; HEART ARRHYTHMIA; HEART FAILURE; HUMAN; HYPERKALEMIA; HYPERTHERMIA; HYPERTRIGLYCERIDEMIA; HYPOTENSION; KIDNEY FAILURE; LIVER DYSFUNCTION; LIVER FAILURE; LONG TERM CARE; MALE; MEDICAL ERROR; METABOLIC ACIDOSIS; MORTALITY; MOTOR DYSFUNCTION; MULTIPLE ORGAN FAILURE; POLYNEUROPATHY; PRIORITY JOURNAL; RESPIRATORY FAILURE; RHABDOMYOLYSIS; RISK FACTOR; SEDATION; SEPSIS; TREMOR; UNITED STATES; UNSPECIFIED SIDE EFFECT; WEAKNESS;

ACIDOSIS; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; CARDIOVASCULAR SYSTEM; CHILD; HUMANS; HYPNOTICS AND SEDATIVES; HYPOTENSION; INFUSIONS, INTRAVENOUS; MORTALITY; PROPOFOL; RISK FACTORS; SAFETY; SYNDROME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33750434512     PISSN: 00033022     EISSN: 15281175     Source Type: Journal    
DOI: 10.1097/00000542-200611000-00027     Document Type: Article

References (71)

1. Parke TJ, Stevens JE, Rice AS, Greenaway CL, Bray RJ, Smith PJ, Waldmann CS, Verghese C: Metabolic acidosis and fatal myocardial failure after propofol infusion in children: Five case reports. BMJ 1992; 305:613-6
2. Bray RJ: Fatal myocardial failure associated with a propofol infusion in a child (letter). Anaesthesia 1995; 50:94
3. Plotz FB, Waalkens HJ, Verkade HJ, Strengers JLM, Knoester H, Mandema JM: Fatal side effects of continuous propofol infusion in children may be related to malignant hyperthermia (letter). Anaesth Intensive Care 1996; 24:724
4. Bray RJ: Propofol infusion syndrome in children. Paediat Anaesth 1998; 8:491-9
5. Hanna JP, Ramundo ML: Rhabdomyolysis and hypoxia associated with prolonged propofol infusion in children. Neurology 1998; 50:301-3
6. Canivet JL, Gustad K, Leclercq P, Damas P, Lamy M: Massive ketonuria during sedation with propofol in a 12 year old girl with severe head trauma. Acta Anaesthesiol Belg 1994; 45:19-22
7. van Straaten EA, Hendriks JJE, Ramsey G, Vos GD: Rhabdomyolysis and pulmonary hypertension in a child, possibly due to long-term high-dose propofol infusion (letter). Intensive Care Med 1996; 22:997
8. Strickland RA, Murray MJ: Fatal metabolic acidosis in a pediatric patient receiving an infusion of propofol in the intensive care unit: Is there a relationship? Crit Care Med 1995; 23:405-9
9. Barclay K, Williams AJ, Major E: Propofol infusion in children (letter). BMJ 1992; 305:953
10. El-Ebiary M, Torres A, Ramirez J, Xaubert A, Rodriguez-Roisin R: Lipid deposition during the long-term infusion of propofol. Crit Care Med 1995; 23:1928-30
11. Mehta N, DeMunter C, Habibi P, Nadel S, Britto J: Short-term propofol infusions in children (letter). Lancet 1999; 354:866-7
12. Cray SH, Robinson BH, Cox PN: Lactic academia and bradyarrhythmia in a child sedated with propofol. Crit Care Med 1998; 26:2087-92
13. Perrier ND, Baerga-Varela Y, Murray MJ: Death related to propofol use in an adult patient. Crit Care Med 2000; 28:3071-4
14. Cremer OL, Moons KGM, Bouman EA, Kruijswijk JE, de Smet AMGA, Kalkman CJ: Long-term propofol infusion and cardiac failure in adult head-injured patients (research letter). Lancet 2001; 357:117-8
15. Cannon ML, Glazier SS, Bauman LA: Metabolic acidosis, rhabdomyolysis, and cardiovascular collapse after prolonged propofol infusion. J Neurosurg 2001; 95:1053-6
16. Okamoto MP, Kawaguchi DL, Amin AN: Evaluation of propofol infusion syndrome in pediatric intensive care. Am J Health Syst Pharm 2003; 60:2007-14
17. Kang TM: Propofol infusion syndrome in critically ill patients. Ann Pharmacother 2002; 36:1453-6
18. Abrahams JM, Reiter GT, Acker MA, Sinson GP: Propofol (letter). J Neurosurg 2002; 96:1160-1
19. Holzki J, Aring C, Gillor A: Death after re-exposure to propofol in a 3-year-old child: A case report. Pediatr Anesth 2004; 14:265-70
20. Casserly B, O'Mahony E, Timm EG, Haqqie S, Eisele G, Urizar R: Propofol infusion syndrome: An unusual cause of renal failure. Am J Kidney Dis 2004; 44:E98-101
21. Baumeister FA, Oberhoffer R, Liebhaber GM, Kunkel J, Eberhardt J, Holthausen H, Peters J: Fatal propofol infusion syndrome in association with ketogenic diet. Neuropediatrics 2004; 35:250-2
22. Withington DE, Decell MK, Al Ayed T: A case of propofol toxicity: Further evidence for a causal mechanism. Pediatr Anesth 2004; 14:505-8
23. Kill C, Leonhardt A, Wulf H: Lactic acidosis after short-term infusion of propofol for anaesthesia in a child with osteogenesis imperfecta. Paediatr Anaesth 2003; 13:823-6
24. Sochala C, Van Deenen D, De Ville A, Govaerts MJM: Heart block following propofol in a child. Paediatr Anaesth 1999; 9:349-51
25. Koch M, De Backer D, Vincent J-L: Lactic acidosis: An early marker of propofol infusion syndrome? (letter). Intensive Care Med 2004; 30:522
26. Cornfield DN, Tegtmeyer K, Nelson MD, Milla CE, Sweeney M: Continuous propofol infusion in 142 critically ill children. Pediatrics 2002; 110:1177-81
27. Martin PH, Murthy BVS, Petros AJ: Metabolic, biochemical and haemodynamic effects of infusion of propofol for long-term sedation of children undergoing intensive care. Br J Anaesthesia 1997; 79:276-9
28. Vardi A, Salem Y, Padeh S, Paret G, Barzilay Z: Is propofol safe for procedural sedation in children? A prospective evaluation of propofol versus ketamine in pediatric critical care. Crit Care Med 2002; 30:1231-6
29. Rigby-Jones AE, Nolan JA, Priston MJ, Wright PMC, Sneyd JR, Wolf AR: Pharmacokinetics of propofol infusions in critically ill neonates, infants, and children in an intensive care unit. ANESTHESIOLOGY 2002; 97:1393-400
30. Stelow EB, Johari VP, Smith SA, Crosson JT, Apple FS: Propofol-associated rhabdomyolysis with cardiac involvement in adults: Chemical and anatomic findings. Clin Chem 2000; 46:577-81
31. Badr A, Mychaskiw GII, Eichhorn JH: Metabolic acidosis associated with a new formulation of propofol. ANESTHESIOLOGY 2001; 94:536-8
32. Kelly DF: Propofol-infusion syndrome (editorial). J Neurosurg 2001; 95:925-6
33. Friedman JA, Manno E, Fulgham JR: Propofol (letter). J Neurosurg 2002; 96:1161-2
34. Ernest D, French C: Propofol infusion syndrome: Report of an adult fatality. Anaesth Intensive Care 2003; 31:316-9
35. Machata AM, Gonano C, Birsan T, Zimpfer M, Spiss CK: Rare but dangerous adverse effects of propofol and thiopental in intensive care. J Trauma 2005; 58:643-5
36. Marinella MA: Lactic acidosis associated with propofol (letter). Chest 1996; 109:292
37. Burow BK, Johnson ME, Packer DL: Metabolic acidosis associated with propofol in the absence of other causative factors. ANESTHESIOLOGY 2004; 101:239-41
38. Salengros J-C, Velghe-Lenelle C-E, Bollens R, Engelman E, Barvais L: Lactic acidosis during propofol-remifentanil anesthesia in an adult. ANESTHESIOLOGY 2004; 101:241-3
39. Funston JS, Prough DS: Two reports of propofol anesthesia associated with metabolic acidosis in adults (editorial). ANESTHESIOLOGY 2004; 101:6-8
40. Johnson ME, Cravens GT: Incidence of propofol infusion (abstract). ANESTHESIOLOGY 2005; 103:A-673
41. Liolios A, Guerit JM, Scholtes JL, Raftopoulos C, Hantson P: Propofol infusion syndrome associated with short-term large-dose infusion during surgical anesthesia in an adult. Anesth Analg 2005; 100:1804-6
42. Politis P, Zakynthinos E, Kotanidou A, Andrianakis I, Roussos C: Propofol use in head injury patients (letter). Lancet 2001; 357:1710
43. Cremer OL, Moons KGM, Kalkman CJ: Propofol use in head-injury patients (letter). Lancet 2001; 357:1709-10
44. Watson WA, Litovitz TL, Klein-Schwartz W, Rodgers GC Jr, Youniss J, Reid N, Rouse WG, Rembert RS, Borys D: 2003 annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med 2004; 22:335-404
45. Leisure GS, O'Flaherty J, Green L, Jones DR: Propofol and postoperative pancreatitis. ANESTHESIOLOGY 1996; 84:224-7
46. Hug CC Jr, McLeskey CH, Nahrwold ML, Roizen MF, Stanley TH, Thisted RA, Walawander CA, White PF, Apfelbaum JL, Grasela TH: Hemodynamic effects of propofol: Data from over 25,000 patients. Anesth Analg 1993; 77:S21-9
47. McLeskey CH, Walawander CA, Nahrwold ML, Roizen MF, Stanley TH, Thisted RA, White PF, Apfelbaum JL, Grasela TH, Hug CC Jr: Adverse events in a multicenter phase IV study of propofol: Evaluation by anesthesiologists and postanesthesia care unit nurses. Anesth Analg 1993; 77:S3-9
48. Apfelbaum JL, Grasela TH, Hug CC Jr, McLeskey CH, Nahrwold ML, Roizen MF, Stanley TH, Thisted RA, Walawander CA, White PF: The initial clinical experience of 1819 physicians in maintaining anesthesia with propofol: Characteristics associated with prolonged time to awakening. Anesth Analg 1993; 77:S10-4
49. Prasad A, Worrall BB, Bertram EH, Bleck TP: Propofol and midazolam in the treatment of refractory status epilepticus. Epilepsia 2001; 42:380-6
50. Niermeijer J-MF, Uiterwaal CSPM, van Donselaar CA: Propofol in status epilepticus: Little evidence, many dangers? J Neurol 2003; 250:1237-40
51. Wolf AR, Mychaskiw G II, Potter F: Propofol infusion in children: When does an anesthetic tool become an intensive care liability? (editorial). Pediatr Anesth 2004; 14:435-8
52. Johnson ME: Metabolic acidosis due to propofol infusion (letter). ANESTHESIOLOGY 2005; 102:698
53. James MFM, Reyneke CJ, Whiffler K: Heart block following propofol: A case report. Br J Anaesth 1989; 62:213-5
54. Dorrington KL: Asystole with convulsion following a subanaesthetic dose of propofol plus fentanyl. Anaesthesia 1989; 44:658-9
55. Guise PA: Asystole following propofol and fentanyl in an anxious patient. Anaesth Intensive Care 1991; 19:116-8
56. Warden JC, Pickford DR: Fatal cardiovascular collapse following propofol induction in high-risk patients and dilemmas in the selection of a short-acting induction agent. Anaesth Intensive Care 1995; 23:485-7
57. Reed MD, Blumer JL: Propofol bashing: The time to stop is now! (letter). Crit Care Med 1996; 24:175-7
58. Wooltorton E: Propofol: Contraindicated for sedation of pediatric intensive care patients. CMAJ 2002; 167:507
59. Hatch DJ: Propofol-infusion syndrome in children. Lancet 1999; 353:1117-18
60. Dearlove O, Dobson A: Does propofol cause deaths in children? (letter). Anaesthesia 1995; 50:916
61. Bray RJ: Propofol-infusion syndrome in children (letter). Lancet 1999; 353:2074
62. Bray RJ: Propofol infusion for ICU sedation in children (letter). Anaesthesia 2002; 57:521
63. Murdoch SD, Cohen AT: Propofol-infusion syndrome in children (letter). Lancet 1999; 353:2074-5
64. Felmet K, Nguyen T, Clark RS, Orr D, Carcillo J: The FDA warning against prolonged sedation with propofol in children remains warranted (letter). Pediatrics 2003; 112:1002-3
65. Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA, Murray MJ, Peruzzi WT, Lumb PD, Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM) American Society of Health-System Pharmacists (ASHP) American College of Chest Physicians: Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med 2002; 30:119-41
66. Wysowski DK, Swartz L: Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: The importance of reporting suspected reactions. Arch Intern Med 2005; 165:1363-9
67. Markovitz BP: Continuous propofol infusion in 142 critically ill children (letter). Pediatrics 2003; 112:1460-1
68. Brussel T, Theissen JL, Vigfusson G, Lunkenheimer PP, Van Aken H, Lawin P: Hemodynamic and cardiodynamic effects of propofol and etomidate: Negative inotropic properties of propofol. Anesth Analg 1989; 69:35-40
69. Zhou W, Fontenot HJ, Wang S-N, Kennedy RH: Propofol-induced alterations in myocardial β-adrenoreceptor binding and responsiveness. Anesth Analg 1999; 89:604-8
70. Schenkman KA, Yan S: Propofol impairment of mitochondrial respiration in isolated perfused guinea pig hearts determined by reflectance spectroscopy. Crit Care Med 2000; 28:172-7
71. Wolf A, Weir P, Segar P, Stone J, Shield J: Impaired fatty acid oxidation in propofol infusion syndrome (letter). Lancet 2001; 357:606-7