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

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Abstract

Transdermal fentanyl is effective and well tolerated for the treatment of chronic pain caused by malignancy and non-malignant conditions when administered according to the manufacturer’s recommendations. Compared with oral opioids, the advantages of transdermal fentanyl include a lower incidence and impact of adverse effects (constipation, nausea and vomiting, and daytime drowsiness), a higher degree of patient satisfaction, improved quality of life, improved convenience and compliance resulting from administration every 72 hours, and decreased use of rescue medication. Transdermal fentanyl is a useful analgesic for cancer patients who are unable to swallow or have gastrointestinal problems.

Transdermal fentanyl forms a depot within the upper skin layers before entering the microcirculation. Therapeutic blood levels are attained 12–16 hours after patch application and decrease slowly with a half-life of 16–22 hours following removal. Patients with chronic pain should be titrated to adequate relief with short-acting oral or parenteral opioids prior to the initiation of transdermal fentanyl in order to prevent exacerbations of pain or opioid-related adverse effects. Transdermal fentanyl can then be initiated based on the 24-hour opioid requirement once adequate analgesia has been achieved.

The prolonged elimination of transdermal fentanyl can become problematic if patients develop opioid-related adverse effects, especially hypoventilation. Adverse effects do not improve immediately after patch removal and may take many hours to resolve. Patients who experience opioid-related toxicity associated with respiratory depression should be treated immediately with an opioid antagonist such as naloxone and closely monitored for at least 24 hours. Because of the short half-life of naloxone, sequential doses or a continuous infusion of the opioid antagonist may be necessary. Transdermal fentanyl should be administered cautiously to patients with pre-existing conditions such as emphysema that may predispose them to the development of hypoventilation.

Transdermal fentanyl is indicated only for patients who require continuous opioid administration for the treatment of chronic pain that cannot be managed with other medications. It is contraindicated in the management of acute and postoperative pain, as pain may decrease more rapidly in these circumstances than fentanyl blood levels can be adjusted, leading to the development of life-threatening hypoventilation.

Cognitive and physical impairments such as confusion and abnormal co-ordination can occur with transdermal fentanyl. Therefore, patients should be instructed to refrain from driving or operating machinery immediately following the initiation of transdermal fentanyl, or after any dosage increase. Patients may resume such activities once the absence of these potential adverse effects is documented.

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References

  1. Woodroofe MA, Hays H. Fentanyl transdermal system: pain management at home. Can Fam Physician 1997; 43: 268–72

    Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  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

    Article  Google Scholar 

  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

    Google Scholar 

  6. Bovill JG. Which potent opioid? Important criteria for selection. Drugs 1987; 33: 520–30

    Article  PubMed  CAS  Google Scholar 

  7. Mather LE. Clinical pharmacokinetics of fentanyl and its newer derivatives. Clin Pharmacokinet 1983; 8(5): 422–46

    Article  PubMed  CAS  Google Scholar 

  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

    Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  Google Scholar 

  12. Dellemijn PL, Van Duijn H, Vanneste JA. Prolonged treatment with transdermal fentanyl in neuropathic pain. J Pain Symptom Manage 1998; 16: 220–9

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  14. Miser AW, Narang PK, Dothage JA, et al. Transdermal fentanyl for pain control in patients with cancer. Pain 1989; 37: 15–21

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  16. Lehmann KA, Zech D. Transdermal fentanyl: clinical pharmacology. J Pain Symptom Manage 1992; 7: S8–16

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  19. Roberge RJ, Krenzelok EP, Mrvos R. Transdermal drug delivery system exposure outcomes. J Emerg Med 2000; 18: 147–51

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  21. Rung GW, Riemondy S. The effect of skin temperature on transdermal fentanyl therapy [abstract]. Anesth Analg 1993; Suppl. 76: 363

    Google Scholar 

  22. Southam MA. Transdermal fentanyl therapy: system design, pharmacokinetics, and efficacy. Anticancer Drugs 1995; 6Suppl. 3: 29–34

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  Google Scholar 

  26. Broome IJ, Wright BM, Bower S, et al. Postoperative analgesia with transdermal fentanyl following lower abdominal surgery. Anaesthesia 1995; 50: 300–3

    Article  PubMed  CAS  Google Scholar 

  27. Esteve M, Levron JC, Flaisler B, et al. Does aging modify pharmacokinetics of transdermal fentanyl? [abstract]. Anesthesiology 1991; 75(3A): A705

    Article  Google Scholar 

  28. Plezia PM, Kramer TH, Linford J, et al. Transdermal fentanyl: pharmacokinetics and preliminary clinical evaluation. Pharmacotherapy 1989; 9: 2–9

    PubMed  CAS  Google Scholar 

  29. Van Bastelaere M, Rolly G, Van Peer A. Pharmacokinetic behavior of transdermal fentanyl [abstract]. Br J Anaesth 1993; 70Suppl. 1: 75

    Google Scholar 

  30. Portenoy RK, Southam MA, Gupta SK, et al. Transdermal fentanyl for cancer pain: repeated dose pharmacokinetics. Anesthesiology 1993; 78: 36–43

    Article  PubMed  CAS  Google Scholar 

  31. Payne R. Transdermal fentanyl: suggested recommendations for clinical use. J Pain Symptom Manage 1992; 7: S40–4

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  33. Von Bormann B. Clinical experience. In: Lehmann KA, Zech D, editors. Transdermal fentanyl. Berlin: Springer, 1991: 119–40

    Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  35. Scholz J, Steinfath M, Schulz M. Clinical pharmacokinetics of alfentanil, fentanyl, and sufentanil: an update. Clin Pharmacokinet 1996; 31(4): 275–92

    Article  PubMed  CAS  Google Scholar 

  36. Grond S, Radbruch L, Lehmann KA. Clinical pharmacokinetics of transdermal opioids: focus on transdermal fentanyl. Clin Pharmacokinet 2000; 38(1): 59–89

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  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

    CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  42. Herbst LH, Strause LG. Transdermal fentanyl use in home-care patients with chronic cancer pain. J Pain Symptom Manage 1992; 7Suppl. 3: S54–7

    Article  PubMed  CAS  Google Scholar 

  43. Slover R. Transdermal fentanyl: clinical trial at the University of Colorado Health Sciences Center. J Pain Symptom Manage 1992; 7Suppl. 3: S45–7

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  45. Maves TJ, Barcellos WA. Management of cancer pain with transdermal fentanyl: phase IV trial, University of Iowa. J Pain Symptom Manage 1992; 7Suppl. 3: S58–62

    Article  PubMed  CAS  Google Scholar 

  46. Simmonds MA, Richenbacher J. Transdermal fentanyl: long-term analgesic studies. J Pain Symptom Manage 1992; 7: S36–9

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  51. Mercadante S. Opioid rotation for cancer pain: rationale and clinical aspects. Cancer 1999; 86: 1856–66

    Article  PubMed  CAS  Google Scholar 

  52. Ahmedzai S, Allan E, Fallon M, et al. Transdermal fentanyl in cancer pain. J Drug Dev 1994; 6: 93–7

    Google Scholar 

  53. Slappendel R, Lako SJ, Crul BJP. Gastrointestinal side effects diminish after switch over from morphine to transdermal fentanyl [abstract P1004]. Ann Oncol 1994; 5Suppl. 8: 200

    Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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; 2Suppl. 1: S35

    Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  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-naive patients and a group using codeine. J Pain Symptom Manage 2000; 19: 185–92

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  60. Elsner F, Radbruch L, Sabatowski R, et al. Switching opioids to transdermal fentanyl in a clinical setting. Schmerz 1999; 13: 273–8

    Article  PubMed  CAS  Google Scholar 

  61. Portenoy RK. Chronic opioid therapy in nonmalignant pain. J Pain Symptom Manage 1990; 5: S46–62

    Article  PubMed  CAS  Google Scholar 

  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

    Google Scholar 

  64. Moulin D, Iezzi A, Amireh R, et al. Randomized trial of oral morphine for chronic non-cancer pain. Lancet 1996; 347: 143–7

    Article  PubMed  CAS  Google Scholar 

  65. Portenoy RK, Foley KM. Chronic use of opioid analgesics in non-malignant pain: report of 38 cases. Pain 1986; 25: 171–86

    Article  PubMed  CAS  Google Scholar 

  66. Portenoy R. Opioid therapy for chronic nonmalignant pain: a review of the critical issues. J Pain Symptom Manage 1996; 11: 203–17

    Article  PubMed  CAS  Google Scholar 

  67. Turk DC. Clinicians’ attitude about prolonged use of opioids and the issue of patient heterogeneity. J Pain Symptom Manage 1996; 11: 218–30

    Article  PubMed  CAS  Google Scholar 

  68. Brena SF, Sanders SH. Opioids in nonmalignant pain: questions in search of answers. Clin J Pain 1991; 7: 342–5

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  70. Bannwarth B. Risk-benefit assessment of opioids in chronic non-cancer pain. Drug Saf 1999; 21(4): 283–96

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  72. Barkin RL, Lubenow TR, Bruehl S, et al. Management of chronic pain: part I and part II. Dis Mon 1996; 42: 385–456

    Article  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  74. Sandler 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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  76. Food and Drug Administration (FDA). Fentanyl transdermal system approved for chronic pain. JAMA 1990; 264: 1802

    Google Scholar 

  77. Vecchione A. Fentanyl linked to patient death in Nevada hospital. Hospital Pharmacist Report 1995; 12: 11

    Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  84. Foley KM. The treatment of cancer pain. N Engl J Med 1985; 313: 84–95

    Article  PubMed  CAS  Google Scholar 

  85. Ashburn MA, Lipman AG. Management of pain in the cancer patient. Anesth Analg 1993; 76: 402–16

    PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  Google Scholar 

  89. Payne R, Chandler S, Einhaus M. Guidelines for the clinical use of transdermal fentanyl. Anticancer Drugs 1995; 6Suppl. 3: 50–3

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  91. Brooks D. Day-to-day titration of transdermal fentanyl is unwise [letter; comment]. Support Care Cancer 1995; 3: 210–1

    Article  PubMed  CAS  Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  93. The TTS Fentanyl Multicentre Study Group. Transdermal fentanyl in cancer pain. J Drug Dev 1994; 6: 93–7

    Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  98. Bernstein KJ. Inappropriate use of transdermal fentanyl for acute postoperative pain [letter]. J Oral Maxillofac Surg 1994; 52: 896

    Article  PubMed  CAS  Google Scholar 

  99. Rose PG, Macfee MS, Boswell MV. Fentanyl transdermal system overdose secondary to cutaneous hyperthermia. Anesth Analg 1993; 77: 390–1

    PubMed  CAS  Google Scholar 

  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

    Article  PubMed  Google Scholar 

  101. Newshan G. Heat-related toxicity with the fentanyl transdermal patch. J Pain Symptom Manage 1998; 16: 277–8

    Article  PubMed  CAS  Google Scholar 

  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

    Article  Google Scholar 

  103. Klockgether-Radke A, Hildebrandt J. Opioidintoxikation. Unsachgemässe Anwendung von transdermalem Fentanyl. Anaesthesist 1997; 46: 428–9

    Article  PubMed  CAS  Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  105. Marquardt KA, Tharratt RS. Inhalation abuse of fentanyl patch. Clin Toxicol 1994; 32: 75–8

    Article  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  107. Kramer C, Tawney M. A fatal overdose of transdermally administered fentanyl. J Am Osteopath Assoc 1998; 98: 385–6

    PubMed  CAS  Google Scholar 

  108. Edinboro LE, Poklis A, Trautman D, et al. Fatal fentanyl intoxication following excessive transdermal application. J Forensic Sci 1997; 42: 741–3

    PubMed  CAS  Google Scholar 

  109. Davies AN, Bond C. Transdermal fentanyl and the opioid withdrawal syndrome [letter]. Palliat Med 1996; 10: 348

    PubMed  CAS  Google Scholar 

  110. Higgs CM, Vella-Brincat J. Withdrawal with transdermal fentanyl [letter; comment]. J Pain Symptom Manage 1995; 10: 4–5

    Article  PubMed  CAS  Google Scholar 

  111. Zenz M, Donner B, Strumpf M. Withdrawal symptoms during therapy with transdermal fentanyl (fentanyl TTS)? J Pain Symptom Manage 1994; 9: 54–5

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  Google Scholar 

  113. Kuzma PJ, Kline MD, Stamatos JM, et al. Acute toxic delirium: an uncommon reaction to transdermal fentanyl. Anesthesiology 1995; 83: 869–71

    Article  PubMed  CAS  Google Scholar 

  114. Steinberg RB, Gilman DE, Johnson III F. Acute toxic delirium in a patient using transdermal fentanyl. Anesth Analg 1992; 75: 1014–6

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  PubMed  CAS  Google Scholar 

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Acknowledgements

Craig Kornick, M.D., and Natalia Moryl, M.D., were sponsored by the National Cancer Institute’s Psychiatry and Pain Research Training Grant (T32-CA09461), Department of Health and Human Services, Public Health Service. Juan Santiago-Palma, M.D., was sponsored in part by the Hale Matthews Foundation and a supportive care and rehabilitation fund of the Henry and Lucy Moses Foundation. We acknowledge Glenn Schulman, Pharm.D., in the Department of Pharmacy at Memorial Sloan-Kettering Cancer Center for his assistance in the construction of the average wholesale price table. We appreciate the assistance of Kristan Hahn in the preparation of the manuscript.

Richard Payne M.D. is a member of Janssen’s Chronic Pain Scientific Advisory Board. Craig Kornick, M.D., Natalia Moryl, M.D. and Richard Payne M.D. have received honororia from Janssen Pharmaceutica for speaking engagements.

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Authors and Affiliations

  1. Department of Neurology, Memorial Sloan-Kettering Cancer Center, Pain and Palliative Care Service, New York, New York, USA

    Craig A. Kornick, Juan Santiago-Palma, Natalia Moryl, Richard Payne & Eugenie A.M.T. Obbens

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  1. Craig A. Kornick
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  2. Juan Santiago-Palma
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  3. Natalia Moryl
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  4. Richard Payne
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  5. Eugenie A.M.T. Obbens
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Correspondence to Craig A. Kornick.

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Riverside Spine and Pain Physicians, P.L. Suite 4-5, 4339 Roosevelt Blvd, Jacksonville, FL 32210, USA.

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Kornick, C.A., Santiago-Palma, J., Moryl, N. et al. Benefit-Risk Assessment of Transdermal Fentanyl for the Treatment of Chronic Pain. Drug-Safety 26, 951–973 (2003). https://doi.org/10.2165/00002018-200326130-00004

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