Propoxyphene and the risk of out-of-hospital death

Pharmacoepidemiology and Drug Safety

Volumn 22, Issue 4, 2013, Pages 403-412

  Ray, Wayne A ^a   Murray, Katherine T ^b,d   Kawai, Vivian ^d   Graham, David J ^e   Cooper, William O ^d   Hall, Kathi ^a   Michael Stein, Charles ^c,d  

^a Division of Pharmacoepidemiology   (United States)

^b Division of Cardiology   (United States)

^c Rheumatology (CMS)   (United States)

^d VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

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

Author keywords

Cardiovascular; Pharmacoepidemiology; Propoxyphene; Sudden death

Indexed keywords

DEXTROPROPOXYPHENE; HYDROCODONE;

ADULT; AGED; ARTICLE; CARDIOVASCULAR MORTALITY; COHORT ANALYSIS; DRUG SAFETY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAID; PRESCRIPTION; PRIORITY JOURNAL; REFERENCE DATABASE; RETROSPECTIVE STUDY; SIDE EFFECT; SUDDEN DEATH;

ADULT; AGED; ANALGESICS, OPIOID; COHORT STUDIES; DEATH, SUDDEN, CARDIAC; DEXTROPROPOXYPHENE; FEMALE; HUMANS; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; RISK;

EID: 84875809348     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3411     Document Type: Article

References (48)

1. Obafunwa JO, Busuttil A, Al-Oqleh AMAH. Dextropropoxyphene-related deaths - a problem that persists? Int J Leg Med 1994; 106: 315-318.
2. Li-Wan-Po A, Zhang WY. Systematic overview of co-proxamol to assess analgesic effects of addition of dextroporpoxyphene to paracetamol. BMJ 1997; 315: 1565-1571.
3. Hawton K, Simkin S, Deeks J. Co-proxamol and suicide: a study of national mortality statistics and local non-fatal self poisonings. BMJ 2003; 326: 1006-1008.
4. Afshari R, Good AM, Maxwell SRJ, Bateman DN. Co-proxamol overdose is associated with a 10-fold excess mortality compared with other paracetamol combination analgesics. Br J Clin Pharmac 2005; 60: 444-447.
5. Afshari R, Maxwell S, Dawson A, Bateman DN. ECG abnormalities in co-proxamol (paracetamol/dextropropoxyphene) poisoning. Clin Toxicol 2005; 43: 255-259.
6. Heaney RM. Left bundle branch block associated with propoxyphene hydrochloride poisoning. Ann Emerg Med 1983; 12: 780-782.
7. Whitcomb DC, Gilliam FR, Starmer CF, Grant AO. Marked QRS complex abnormalities and sodium channel blockade by propoxyphene reversed with lidocaine. J Clin Invest 1989; 84: 1629-1636.
8. Committee on the Safety of Medicines of the United Kingdom. Overdose risk prompts UK withdrawal of propoxyphene combination. J Pain Pallliative Care Pharmacotherapy 2006; 20: 49-50.
9. Bateman ND, Sandilands EA. European medicines evaluation agency bans dextroporpoxyphene: a landmark decision for clinical toxicology? Clin Toxicol 2009; 47: 783.
10. FDA News Release. Xanodyne Agrees to Withdraw Propoxyphene from the U.S. Market. FDA 2010;888-INFO-FDA.
11. Paulozzi L, Ryan GW. Opioid analgesics and rates of fatal drug poisoning in the United States. Am J Prev Med 2006; 31: 506-511.
12. Okie S. A flood of opioids, a rising ride of deaths. N Engl J Med 2010; 363: 1981-1985.
13. Hudson P, Barringer M, McBay AJ. Fatal poisoning with propoxyphene: report from 100 consecutive cases. South Med J 1977; 70: 938-942.
14. Wetli CV, Bednarczyk LR. Deaths related to propoxyphene overdose: a ten-year assessment. South Med J 1980; 73: 1205-1209.
15. Jonasson B, Jonasson U, Saldeen T. The manner of death among fatalities where dextropropoxyphene caused or contributed to death. Forensic Sci Int 1998; 96: 181-187.
16. Jonasson U, Jonasson B, Saldeen T. Correlation between prescription of various dextropropoxyphene preparations and their involvement in fatal poisonings. Forensic Sci Int 1999; 103: 125-132.
17. Man CY. Overdose of dologesic with a fatal outcome: a case report. Hong Kong J Emerg Med 2001; 8: 207-211.
18. Hawton K, Simkin S, Gunson K, et al. A multicentre study of coproxamol poisoning suicides based on coroners' records in England. Br J Clin Pharmac 2004; 59: 207-212.
19. Jang DH, Hoffman RS, Nelson LS, Chu J, Bhanot K, Bagley W. Fatal outcome of a propoxyphene/acetaminophen (Darvocet) overdose: should it still be used in the United States? Ann Emerg Med 2011; 57: 421-422.
20. Madsen PS, Strom J, Reiz S, Sorensen MB. Acute propoxyphene self-poisoning in 222 consecutive patients. Acta Anaesthesiol Scand 1984; 28: 661-665.
21. Holland DR, Steinberg MI. Electrophysiologic properties of propoxyphene and norpropoxyphene in canine cardiac conducting tissues in vitro and in vivo. Toxicol Appl Pharmacol 1979; 47: 123-133.
22. Wu C, Fry CH, Henry J. The mode of action of several opioids on cardiac muscle. Exp Physiol 1997; 82: 261-272.
23. Amsterdam EA, Rendig SV, Henderson GL, Mason DT. Depression of myocardial contractile function by propoxyphene and norpropoxyphene. J Cardiovasc Pharmacol 1981; 3: 129-138.
24. Seyler DE, Borowitz JL, Maickel RP. Calcium channel blockade by certain opioids. Fundam Appl Toxicol 1983; 3: 536-542.
25. Roden DM. Drug-induced prolongation of the QT interval. N Engl J Med 2004; 350: 1013-1022.
26. Kannankeril P, Roden DM, Darbar D. Drug-induced long QT syndrome. Pharmacol Rev 2010; 62: 760-781.
27. Ray WA. Population-based studies of adverse drug effects. N Engl J Med 2003; 349: 1592-1594.
28. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996; 125: 605-613.
29. Von Korff M, Saunders K, Ray GT, et al. De facto long-term opioid therapy for noncancer pain. Clin J Pain 2008; 24: 521-527.
30. Chung CP, Murray KT, Stein CM, Hall K, Ray WA. A computer case definition for sudden cardiac death. Pharmacoepidemiol Drug Saf 2010; 19: 563-572.
31. Ray WA, Griffin MR. Use of Medicaid data for pharmacoepidemiology. Am J Epidemiol 1989; 129: 837-849.
32. Liberthson RR. Sudden death from cardiac causes in children and young adults. N Engl J Med 1996; 334: 1039-1044.
33. Glynn RJ, Schneeweiss S, Sturmer T. Indications for propensity scores and review of their use in pharmacoepidemiology. Basic Clin Pharmacol Toxicol 2006; 98: 253-259.
34. Marcus FI, Cobb LA, Edwards JE, et al. Mechanism of death and prevalence of myocardial ischemic symptoms in the terminal event after acute myocardial infarction. Am J Cardiol 1988; 61: 8-15.
35. Hinkle LE, Thaler HT. Clinical classification of cardiac deaths. Circulation 1982; 65: 457-464.
36. Siscovick DS, Raghunathan TE, Psaty BM, et al. Diuretic therapy for hypertension and the risk of primary cardiac arrest. N Engl J Med 1994; 330: 1852-1857.
37. Albert CM, Hennekens CH, O'Donnell CJ, et al. Fish consumption and risk of sudden cardiac death. JAMA 1998; 279: 23-28.
38. Kawai VK, Murray KT, Stein CM, et al. Validation of a computer case definition for sudden cardiac death in opioid users. BMC Research Notes 2012; 5: 473.
39. Landen MG, Castle S, Nolte KB, et al. Methodological issues in the surveillance of poisoning, illicit drug overdose, and heroin overdose deaths in New Mexico. Am J Epidemiol 2011; 157: 273-278.
40. Paulozzi LJ, Xi Y. Recent changes in drug poisoning mortality in the United States by urban-rural status and by drug type. Pharmacoepidemiol Drug Saf 2008; 17: 997-1005.
41. Dunn KM, Saunders KW, Rutter CM, et al. Opioid prescriptions for chronic pain and overdose. Ann Intern Med 2010; 152: 85-92.
42. Arnold SF. Mathematical Statistics. Prentice-Hall 1990;157.
43. Adler A, Viskin S, Bhuiyan ZA, Eisenberg E, Rosso R. Propoxyphene-induced torsades de pointes. Hear Rhythm 2011; 8: 1952-1954.
44. Landry JA, Smyer MA, Tubman JG, Lago DJ, Roberts J, Simonson W. Validation of two methods of data collection of self-reported medicine use among the elderly. Gerontologist 1988; 28: 672-676.
45. West SL, Savitz DA, Koch G, Strom BL, Guess HA, Hartzema A. Recall accuracy for prescription medications: self-report compared with database information. Am J Epidemiol 1995; 142: 1103-1110.
46. Johnson RE, Vollmer WM. Comparing sources of drug data about the elderly. J Am Geriatr Soc 1991; 39: 1079-1084.
47. Ray WA. Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol 2003; 158: 915-920.
48. Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research. (1st edn, London: Arnold, 2000.