Benefit-Risk Assessment of Transdermal Fentanyl for the Treatment of Chronic Pain

Drug Safety

Volumn 26, Issue 13, 2003, Pages 951-973

  Kornick, Craig A ^a,b   Santiago Palma, Juan ^a   Moryl, Natalia ^a   Payne, Richard ^a   Obbens, Eugenie A M T ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b Riverside Spine and Pain Physicians   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALCOHOL; ANESTHETIC AGENT; ANTICONVULSIVE AGENT; ANTIHISTAMINIC AGENT; CENTRAL DEPRESSANT AGENT; CODEINE; DEXTROPROPOXYPHENE; DIAMORPHINE; DIHYDROMORPHINE; FENTANYL; HYDROCODONE; HYDROMORPHONE; LEVORPHANOL; METHADONE; MORPHINE; MORPHINE SULFATE; MUSCLE RELAXANT AGENT; NALOXONE; OPIATE; OPIATE ANTAGONIST; OXYCODONE; OXYMORPHONE; PETHIDINE; PHENOTHIAZINE; SEDATIVE AGENT; TRANQUILIZER;

AGITATION; AMNESIA; ANOREXIA; ANOXIA; ANXIETY DISORDER; APNEA; ASTHENIA; BRADYCARDIA; BRAIN DISEASE; CANCER PAIN; CHRONIC PAIN; CLINICAL TRIAL; COGNITIVE DEFECT; COMA; CONFUSION; CONSTIPATION; DELIRIUM; DEPRESSION; DIARRHEA; DRUG CONTRAINDICATION; DYSPEPSIA; DYSPNEA; EDEMA; EMPHYSEMA; ERYTHEMA; EUPHORIA; FLATULENCE; GAIT DISORDER; HALLUCINATION; HEADACHE; HEART ARRHYTHMIA; HEMOPTYSIS; HICCUP; HUMAN; HYPOTENSION; HYPOVENTILATION; INSOMNIA; NAUSEA; NERVOUSNESS; ORTHOSTATIC HYPOTENSION; PAPULE; PARANOID PSYCHOSIS; PARESTHESIA; PATIENT COMPLIANCE; PATIENT SATISFACTION; PHARYNGITIS; PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE; RASH; RESPIRATION DEPRESSION; REVIEW; RISK BENEFIT ANALYSIS; SIDE EFFECT; SKIN IRRITATION; SOMNOLENCE; SPEECH DISORDER; SWEATING; SYNCOPE; THORAX PAIN; TREMOR; VERTIGO; VOMITING; WITHDRAWAL SYNDROME; XEROSTOMIA;

ADMINISTRATION, CUTANEOUS; ANALGESICS, OPIOID; BODY WEIGHT; CHRONIC DISEASE; FEMALE; FENTANYL; HUMANS; MALE; PAIN; RISK ASSESSMENT; SEX FACTORS;

EID: 0142186036     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200326130-00004     Document Type: Review

References (119)

1. Woodroofe MA, Hays H. Fentanyl transdermal system: pain management at home. Can Fam Physician 1997; 43: 268-72
2. Ahmedzai S, Brooks D. Transdermal fentanyl versus sustained-release oral morphine in cancer pain: preference, efficacy, and quality of life. J Pain Symptom Manage 1997; 13: 254-61
3. Payne R, Mathias SD, Pasta DJ, et al. Quality of life and cancer pain: satisfaction and side effects with transdermal fentanyl versus oral morphine. J Clin Oncol 1998; 16: 1588-93
4. McCarber BH, Barkin RL. Long-acting opioids for chronic pain: pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia. Am J Ther 2001; 8: 181-6
5. Reisine T, Pasternak G. Opioid analgesics and antagonists. In: Molinoff PB, Ruddon RW, editors. Goodman and Gilman's the pharmacological basis of therapeutics. New York (NY): McGraw-Hill, 1996: 543-544
6. Bovill JG. Which potent opioid? Important criteria for selection. Drugs 1987; 33: 520-30
7. Mather LE. Clinical pharmacokinetics of fentanyl and its newer derivatives. Clin Pharmacokinet 1983; 8 (5): 422-46
8. Simmonds MA, Payne R, Richenbacher J, et al. TTS fentanyl in the management of pain in patients with cancer [abstract]. Proc Am Soc Clin Oncol 1989; 8: 324
9. Zech D, Grond S, Lynch J, et al. Transdermal fentanyl and initial dose-finding with patient-controlled analgesia in cancer pain: a pilot study with 20 terminally ill cancer patients. Pain 1992; 50: 293-301
10. Grond S, Zech D, Lehmann K, et al. Transdermal fentanyl in the long-term treatment of cancer pain: a prospective study of 50 patients with advanced cancer of the gastrointestinal tract or the head and neck region. Pain 1997; 69: 191-8
11. Simpson K, Edmonson EA, Constant CE, et al. Transdermal fentanyl as treatment for chronic low back pain. J Pain Symptom Manage 1997; 14: 218-24
12. Dellemijn PL, Van Duijn H, Vanneste JA. Prolonged treatment with transdermal fentanyl in neuropathic pain. J Pain Symptom Manage 1998; 16: 220-9
13. Allan L, Hays H, Jensen NH, et al. Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain. BMJ 2001; 322: 1154-8
14. Miser AW, Narang PK, Dothage JA, et al. Transdermal fentanyl for pain control in patients with cancer. Pain 1989; 37: 15-21
15. Gupta SK, Southam M, Gale R, et al. System functionality and physiochemical model of fentanyl transdermal system. J Pain Symptom Manage 1992; 7 (3 Suppl.): S17-26
16. Lehmann KA, Zech D. Transdermal fentanyl: clinical pharmacology. J Pain Symptom Manage 1992; 7: S8-16
17. Janssen Pharmaceutica. Duragesic® (fentanyl transdermal system) [package insert]. Titusville (NJ): Janssen Pharmaceutica Products, L.P., 2001
18. Varvel JR, Shafer SL, Hwang SS, et al. Absorption characteristics of transdermally administered fentanyl. Anesthesiology 1989; 70: 928-34
19. Roberge RJ, Krenzelok EP, Mrvos R. Transdermal drug delivery system exposure outcomes. J Emerg Med 2000; 18: 147-51
20. Roy SD, Flynn GL. Transdermal delivery of narcotic analgesics: pH, anatomical, and subject influences on cutaneous permeability of fentanyl and sufentanil. Pharm Res 1990; 7: 842-7
21. Rung GW, Riemondy S. The effect of skin temperature on transdermal fentanyl therapy [abstract]. Anesth Analg 1993; Suppl. 76: 363
22. Southam MA. Transdermal fentanyl therapy: system design, pharmacokinetics, and efficacy. Anticancer Drugs 1995; 6 Suppl. 3: 29-34
23. Holley FO, Van Steennis C. Postoperative analgesia with fentanyl: pharmacokinetics and pharmacodynamics of constant-rate IV and transdermal delivery. Br J Anaesth 1988; 60; 608-13
24. Gourlay GK, Kowalski SR, Plummer JL, et al. The transdermal administration of fentanyl in the treatment of postoperative pain: pharmacokinetics and pharmacodynamic effects. Pain 1989; 37: 193-202
25. Gourlay GK, Kowalski SR, Plummer JL, et al. The efficacy of transdermal fentanyl in the treatment of postoperative pain: a double-blind comparison of fentanyl and placebo systems. Pain 1990; 20: 21-8
26. Broome IJ, Wright BM, Bower S, et al. Postoperative analgesia with transdermal fentanyl following lower abdominal surgery. Anaesthesia 1995; 50: 300-3
27. Estéve M, Levron JC, Flaisler B, et al. Does aging modify pharmacokinetics of transdermal fentanyl? [abstract]. Anesthesiology 1991; 75 (3A): A705
28. Plezia PM, Kramer TH, Linford J, et al. Transdermal fentanyl: pharmacokinetics and preliminary clinical evaluation. Pharmacotherapy 1989; 9: 2-9
29. Van Bastelaere M, Rolly G, Van Peer A. Pharmacokinetic behavior of transdermal fentanyl [abstract]. Br J Anaesth 1993; 70 Suppl. 1: 75
30. Portenoy RK, Southam MA, Gupta SK, et al. Transdermal fentanyl for cancer pain: repeated dose pharmacokinetics. Anesthesiology 1993; 78: 36-43
31. Payne R. Transdermal fentanyl: suggested recommendations for clinical use. J Pain Symptom Manage 1992; 7: S40-4
32. Duthie DJR, Rowbotham DJ, Wyld R, et al. Plasma fentanyl concentrations during transdermal delivery of fentanyl to surgical patients. Br J Anaesth 1988; 60: 614-8
33. Von Bormann B. Clinical experience. In: Lehmann KA, Zech D, editors. Transdermal fentanyl. Berlin: Springer, 1991: 119-40
34. Barkin RL, Barkin D. Pharmacologic management of acute and chronic pain: focus on drug interactions and patient-specific pharmacotherapeutic selection. South Med J 2001; 94: 756-70
35. Scholz J, Steinfath M, Schulz M. Clinical pharmacokinetics of alfentanil, fentanyl, and sufentanil: an update. Clin Pharmacokinet 1996; 31 (4): 275-92
36. Grond S, Radbruch L, Lehmann KA. Clinical pharmacokinetics of transdermal opioids: focus on transdermal fentanyl. Clin Pharmacokinet 2000; 38 (1): 59-89
37. Thompson JP, Bower S, Liddle AM, et al. Perioperative pharmacokinetics of transdermal fentanyl in elderly and young adult patients. Br J Anaesth 1998; 81: 152-4
38. Collins JJ, Dunkel IJ, Gupta SK, et al. Transdermal fentanyl in children with cancer pain: feasibility, tolerability, and pharmacokinetic correlates. J Pediatr 1999; 134: 319-23
39. Scott JC, Stanski DR. Decreased fentanyl and alfentanil dose requirements with age: a simultaneous pharmacokinetic and pharmacodynamic evaluation. J Pharmacol Exp Ther 1987; 240: 159-66
40. Hammack JE, Mailliard JA, Loprinzi CL, et al. Transdermal fentanyl in the management of cancer pain in ambulatory patients: an open-label pilot study. Pain 1996; 12: 234-40
41. Donner B, Zenz M, Strumpf M, et al. Long-term treatment of cancer pain with transdermal fentanyl. J Pain Symptom Manage 1998; 15: 168-75
42. Herbst LH, Strause LG. Transdermal fentanyl use in home-care patients with chronic cancer pain. J Pain Symptom Manage 1992; 7 Suppl. 3: S54-7
43. Slover R. Transdermal fentanyl: clinical trial at the University of Colorado Health Sciences Center. J Pain Symptom Manage 1992; 7 Suppl. 3: S45-7
44. Sloan PA, Moulin DE, Hayes H. A clinical evaluation of transdermal therapeutic system fentanyl for the treatment of cancer pain. J Pain Symptom Manage 1998; 16: 102-11
45. Maves TJ, Barcellos WA. Management of cancer pain with transdermal fentanyl: phase IV trial, University of Iowa. J Pain Symptom Manage 1992; 7 Suppl. 3: S58-62
46. Simmonds MA, Richenbacher J. Transdermal fentanyl: long-term analgesic studies. J Pain Symptom Manage 1992; 7: S36-9
47. Coyle N, Adelhart J, Foley KM, et al. Character of terminal illness in the advanced cancer patient: pain and other symptoms during the last four weeks of life. J Pain Symptom Manage 1990; 5: 83-93
48. Galer BS, Coyle N, Pasternak GW, et al. Individual variability in the response to different opioids: report of five cases. Pain 1992; 49: 87-91
49. de Stoutz ND, Bruera E, Suarez-Almazor M. Opioid rotation for toxicity reduction in terminal cancer patients. J Pain Symptom Manage 1995; 10: 378-84
50. Bruera E, Pereira J, Watanabe S, et al. Opioid rotation in patients with cancer pain: a retrospective comparison of dose ratios between methadone, hydromorphone, and morphine. Cancer 1996; 78: 852-7
51. Mercadante S. Opioid rotation for cancer pain: rationale and clinical aspects. Cancer 1999; 86: 1856-66
52. Ahmedzai S, Allan E, Fallon M, et al. Transdermal fentanyl in cancer pain. J Drug Dev 1994; 6: 93-7
53. Slappendel R, Lako SJ, Crul BJP. Gastrointestinal side effects diminish after switch over from morphine to transdermal fentanyl [abstract P1004], Ann Oncol 1994; 5 Suppl. 8: 200
54. Hanks GW, de Conno F, Cherny N, et al. Morphine and alternative opioids in cancer pain: the EAPC recommendations. Br J Cancer 2001; 84; 587-93
55. Kornick CA, Santiago-Palma J, Khojainova N. A safe and effective method of converting cancer patients from intravenous to transdermal fentanyl. J Pain 2001; 2 Suppl. 1: S35
56. Fudin J, Toledo-Binette C, Kupiak DM, et al. Quicker dosage adjustment for transdermal fentanyl. Am J Health Syst Pharm 1997; 54: 87-8
57. Vielvoye-Kerkmeer AP, Mattern C, Uitendaal MP. Transdermal fentanyl in opioid-naive cancer pain patients: an open trial using transdermal fentanyl for the treatment of chronic cancer pain in opioid-naïve patients and a group using codeine. J Pain Symptom Manage 2000; 19: 185-92
58. Radbruch L, Sabatowski R, Petzke F, et al. Transdermal fentanyl for the management of cancer pain: a survey of 1005 patients. Palliat Med 2001; 15: 309-21
59. Wong JO, Chiu GL, Tsao CJ, et al. Comparison of oral controlled-release morphine with transdermal fentanyl in terminal cancer pain. Acta Anaesthesiol Sin 1997; 35: 25-32
60. Elsner F, Radbruch L, Sabatowski R, et al. Switching opioids to transdermal fentanyl in a clinical setting. Schmerz 1999; 13: 273-8
61. Portenoy RK. Chronic opioid therapy in nonmalignant pain. J Pain Symptom Manage 1990; 5: S46-62
62. Acute Pain Management Guideline Panel. Acute pain management: operative or medical procedures and trauma: clinical practice guideline. Rockville (MD): Agency for Health Care and Policy Research, Public Health Service, US Department of Health and Human Services; 1992 Feb. AHCPR publication #92-0032
63. Jacox A, Carr DB, Payne R, et al. Management of cancer pain: clinical practice guideline 9. Rockville (MD): Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services; 1994 Mar. AHCPR publication no. 4-0592
64. Moulin D, Iezzi A, Amireh R, et al. Randomized trial of oral morphine for chronic non-cancer pain. Lancet 1996; 347: 143-7
65. Portenoy RK, Foley KM. Chronic use of opioid analgesics in non-malignant pain: report of 38 cases. Pain 1986; 25: 171-86
66. Portenoy R. Opioid therapy for chronic nonmalignant pain: a review of the critical issues. J Pain Symptom Manage 1996; 11: 203-17
67. Turk DC. Clinicians' attitude about prolonged use of opioids and the issue of patient heterogeneity. J Pain Symptom Manage 1996; 11: 218-30
68. Brena SF, Sanders SH. Opioids in nonmalignant pain: questions in search of answers. Clin J Pain 1991; 7: 342-5
69. Burchman SL, Pagel PS. Implementation of a formal treatment agreement for outpatient management of chronic pain with opioid analgesics. J Pain Symptom Manage 1995; 10: 556-63
70. Bannwarth B. Risk-benefit assessment of opioids in chronic non-cancer pain. Drug Saf 1999; 21 (4): 283-96
71. Schofferman J. Long-term use of opioid analgesics for the treatment of chronic pain of nonmalignant origin. J Pain Symptom Manage 1993; 8: 279-88
72. Barkin RL, Lubenow TR, Bruehl S, et al. Management of chronic pain: part I and part II. Dis Mon 1996; 42: 385-456
73. Milligan K, Lanteri-Minet M, Borchert K, et al. Evaluation of long term efficacy and safety of transdermal fentanyl in the treatment of chronic noncancer pain. J Pain 2001; 2: 197-204
74. Sandier AN, Baxter AD, Katz J, et al. A double-blind, placebo-controlled trial of transdermal fentanyl after abdominal hysterectomy: analgesic, respiratory, and pharmacokinetic effects. Anesthesiology 1994; 81: 1169-80
75. Bulow HH, Linnemann M, Berg H, et al. Respiratory changes during treatment of postoperative pain with high dose transdermal fentanyl. Acta Anaesthesiol Scand 1995 Aug; 39 (6): 835-9
76. Food and Drug Administration (FDA). Fentanyl transdermal system approved for chronic pain. JAMA 1990; 264: 1802
77. Vecchione A. Fentanyl linked to patient death in Nevada hospital. Hospital Pharmacist Report 1995; 12: 11
78. A woman sues over painkiller patch [newspaper article]. Persxx Times 1993 Nov 15: 4B
79. Strupp C, Sudhoff T, Germing U, et al. Transdermal fentanyl during high-dose chemotherapy and autologous stem cell support. Oncol Rep 2000; 7: 659-61
80. Mantovani G, Currell L, Macció A, et al. Prevention of nausea and vomiting (N&V) in cancer patients receiving high-dose cisplatin: assessment of the potential antiemetic activity of transdermal fentanyl (TTS-F) compared to standard antiemetic treatment in acute and delayed N&V: first clinical report. Anticancer Res 1999; 19: 3495-502
81. Korte W, de Stoutz N, Morant R. Day-to-day titration to initiate transdermal fentanyl in patients with cancer pain: short-and long-term experiences in a prospective study of 39 patients. J Pain Symptom Manage 1996; 11: 139-46
82. Jeal W, Benfield P. Transdermal fentanyl: a review of its pharmacological properties and therapeutic efficacy in pain control. Drugs 1997; 53 (1); 109-38
83. Breitbart W, Chandler S, Eagel B, et al. An alternative algorithm for dosing transdermal fentanyl for cancer-related pain. Oncology 2000; 14: 695-705
84. Foley KM. The treatment of cancer pain. N Engl J Med 1985; 313: 84-95
85. Ashburn MA, Lipman AG. Management of pain in the cancer patient. Anesth Analg 1993; 76: 402-16
86. Lawlor P, Turner K, Hanson J, et al. Dose ratio between morphine and hydromorphone in patients with cancer pain: a retrospective study. Pain 1997; 72: 79-85
87. Lawlor PG, Turner KS, Hanson J, et al. Dose ratio between morphine and methadone in patients with cancer pain: a retrospective study. Cancer 1998; 82: 1167-73
88. Kornick CA, Santiago-Palma J, Schulman G, et al. A safe and effective method for converting patients from transdermal to intravenous fentanyl for the treatment of acute cancer-related pain. Cancer 2003; 97: 3121-4
89. Payne R, Chandler S, Einhaus M. Guidelines for the clinical use of transdermal fentanyl. Anticancer Drugs 1995; 6 Suppl. 3: 50-3
90. Donner B, Zenz M, Tryba M, et al. Direct conversion from oral morphine to transdermal fentanyl: a multicenter study in patients with cancer pain. Pain 1996; 64: 527-34
91. Brooks D. Day-to-day titration of transdermal fentanyl is unwise [letter; comment]. Support Care Cancer 1995; 3: 210-1
92. Marquardt KA, Tharratt RS, Musallam NA. Fentanyl remaining in a transdermal system following three days of continuous use. Ann Pharmacother 1995; 29: 969-71
93. The TTS Fentanyl Multicentre Study Group. Transdermal fentanyl in cancer pain. J Drug Dev 1994; 6: 93-7
94. Payne R. Factors influencing quality of life in cancer patients: the role of transdermal fentanyl in the management of pain. Semin Oncol 1998; 25 (3 Suppl. 7): 47-53
95. Radbruch L, Sabatowski R, Loick G, et al. Constipation and the use of laxatives: a comparison between transdermal fentanyl and oral morphine. Palliat Med 2000; 14: 111-9
96. Alsahaf MH, Stockwell M. Respiratory failure due to the combined effects of transdermal fentanyl and epidural bupivacaine/diamorphine following radical nephrectomy. J Pain Symptom Manage 2000; 20: 210-3
97. Bernstein KZ, Klausner MA. Potential dangers related to transdermal fentanyl (Duragesic) when used for postoperative pain [letter; comment]. Dis Colon Rectum 1994; 37: 1339-40
98. Bernstein KJ. Inappropriate use of transdermal fentanyl for acute postoperative pain [letter]. J Oral Maxillofac Surg 1994; 52: 896
99. Rose PG, Macfee MS, Boswell MV. Fentanyl transdermal system overdose secondary to cutaneous hyperthermia. Anesth Analg 1993; 77: 390-1
100. Frölich M, Giannotti A, Modell JH. Opioid overdose in a patient using a fentanyl patch during treatment with a warming blanket. Anesth Analg 2001; 93: 647-8
101. Newshan G. Heat-related toxicity with the fentanyl transdermal patch. J Pain Symptom Manage 1998; 16: 277-8
102. Hardwick Jr WE, King WD, Palmisano PA. Respiratory depression in a child unintentionally exposed to transdermal fentanyl patch. South Med 1997; 90: 962-4
103. Klockgether-Radke A, Hildebrandt J. Opioidintoxikation. Unsachgemässe Anwendung von transdermalem Fentanyl. Anaesthesist 1997; 46: 428-9
104. Flannagan LM, Butts JD, Anderson WH. Fentanyl patches left on dead bodies: potential source of drug for abusers. J Forensic Sci 1996; 41: 320-1
105. Marquardt KA, Tharratt RS. Inhalation abuse of fentanyl patch. Clin Toxicol 1994; 32: 75-8
106. DeSio JM, Bacon DR, Peer G, et al. Intravenous abuse of transdermal fentanyl therapy in a chronic pain patient. Anesthesiology 1993; 79: 1139-41
107. Kramer C, Tawney M. A fatal overdose of transdermally administered fentanyl. J Am Osteopath Assoc 1998; 98: 385-6
108. Edinboro LE, Poklis A, Trautman D, et al. Fatal fentanyl intoxication following excessive transdermal application. J Forensic Sci 1997; 42: 741-3
109. Davies AN, Bond C. Transdermal fentanyl and the opioid withdrawal syndrome [letter]. Palliat Med 1996; 10: 348
110. Higgs CM, Vella-Brincat J. Withdrawal with transdermal fentanyl [letter; comment]. J Pain Symptom Manage 1995; 10: 4-5
111. Zenz M, Donner B, Strumpf M. Withdrawal symptoms during therapy with transdermal fentanyl (fentanyl TTS)? J Pain Symptom Manage 1994; 9: 54-5
112. Han PKJ, Arnold R, Bond G, et al. Myoclonus secondary to withdrawal from transdermal fentanyl: case report and literature review. J Pain Symptom Manage 2002; 23: 66-72
113. Kuzma PJ, Kline MD, Stamatos JM, et al. Acute toxic delirium: an uncommon reaction to transdermal fentanyl. Anesthesiology 1995; 83: 869-71
114. Steinberg RB, Gilman DE, Johnson III F. Acute toxic delirium in a patient using transdermal fentanyl. Anesth Analg 1992; 75: 1014-6
115. Song CW, Chelstron LM, Sevit SH, et al. Effects of temperature on blood circulation with laser Doppler method. Int J Radiat Oncol Biol Phys 1989; 17: 1041-7
116. US Department of Health and Human Services. The 2001 DAWN report: narcotic analgesics [online]. Available from URL: http://www.samhsa.gov/oas/ dawn.htm [Accessed 2003 Aug 26]
117. Calis KA, Kohler DR, Corso DM. Transdermally administered fentanyl for pain management. Clin Pharm 1992; 11: 22-36
118. Ferrell BR, Griffith H. Cost issues related to pain management: report from the cancer pain panel of the agency for healthcare policy and research. J Pain Symptom Manage 1994; 9: 221-34
119. Neighbors DM, Bell TJ, Wilson J, et al. Economic evaluation of the fentanyl transdermal system for the treatment of chronic moderate to severe pain. J Pain Symptom Manage 2001; 21: 129-43