Zohydro™ approval by food and drug administration: Controversial or frightening?

Pain Physician

Volumn 17, Issue 4, 2014, Pages

  Manchikanti, Laxmaiah ^a,b   Atluri, Sairam ^c   Candido, Kenneth D ^d   Boswell, Mark V ^e   Simopoulos, Thomas T ^f   Grider, Jay S ^g   Falco, Frank J E ^h,i   Hirsch, Joshua A ^j  

^a PAIN MANAGEMENT CENTER OF PADUCAH   (United States)

^b UNIVERSITY OF LOUISVILLE   (United States)

^c Tri State Spine Care Institute   (United States)

^d UNIVERSITY OF ILLINOIS   (United States)

^e University of Louisville School of Medicine   (United States)

^f BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^g UNIVERSITY OF KENTUCKY   (United States)

^h Mid Atlantic Spine and Pain Physicians   (United States)

ⁱ TEMPLE UNIVERSITY HOSPITAL   (United States)

^j MASSACHUSETTS GENERAL HOSPITAL   (United States)

more..

Author keywords

Addiction; Chronic non cancer pain; Dependency; Food and drug administration; Medical necessity; Misuse; Opioids; Tolerance; Zohydro

Indexed keywords

HYDROCODONE BITARTRATE; HYDROMORPHONE; MORPHINE SULFATE; MORPHINE SULFATE PLUS NALTREXONE; OPIATE; OXYCODONE; OXYMORPHONE; PARACETAMOL; PLACEBO; TAPENTADOL; HYDROCODONE; NARCOTIC ANALGESIC AGENT;

ANALGESIA; ARTHRALGIA; ARTICLE; CHRONIC PAIN; CLINICAL TRIAL (TOPIC); CONSTIPATION; DIARRHEA; DIZZINESS; DRUG APPROVAL; DRUG COST; DRUG DEPENDENCE; DRUG EFFICACY; DRUG FORMULATION; DRUG MISUSE; DRUG OVERDOSE; DRUG RESPONSE; DRUG SAFETY; DRUG USE; FATIGUE; FOOD AND DRUG ADMINISTRATION; HEADACHE; HEALTH CARE COST; HEALTH CARE POLICY; HEALTH STATISTICS; HUMAN; INSOMNIA; INTENTION TO TREAT ANALYSIS; NAUSEA; PAIN; PHARYNGITIS; PRESCRIPTION; PRESCRIPTION DRUG DIVERSION; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SINUSITIS; SOMNOLENCE; SYSTEMATIC REVIEW (TOPIC); UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VOMITING; XEROSTOMIA; CLINICAL PRACTICE; EPIDEMIC; LEGAL ASPECT; OPIATE ADDICTION; PATIENT SAFETY; REVIEW; STATISTICS; UNITED STATES;

ANALGESICS, OPIOID; CHRONIC PAIN; DRUG APPROVAL; EPIDEMICS; HEALTH POLICY; HUMANS; HYDROCODONE; OPIOID-RELATED DISORDERS; PATIENT SAFETY; PHYSICIAN'S PRACTICE PATTERNS; PRESCRIPTION DRUG MISUSE; UNITED STATES;

EID: 84904664481     PISSN: 15333159     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (82)

1. United States Food and Drug Administration. www.fda.gov.
2. United States Food and Drug Administration. About FDA: History. www.fda.gov/aboutfda/whatwedo/history/default.htm
3. Henderson D. Panel: FDA needs more power, funds. Boston Globe. September 23, 2006
4. Institute of Health of the National Academies, Committee on the Assessment of the US Drug Safety System. The Future of Drug Safety: Promoting and Protecting the Health of the Public. The National Academies Press, Washington, DC, 2006
5. Carpenter DP. The political economy of FDA drug review: Processing, politics, and lessons for policy. Health Aff (Millwood) 2004; 23:52-63
6. Friedman M, Friedman R. Who protects the consumer? In: Free to Choose. Harvest House, Eugene, 1980, pp 203-210
7. TAKE IT TO THE LIMITS: Milton Friedman on Libertarianism. Transcript from television show filmed February 10, 1999. The Hoover Institute.
8. DiMasi JA. The value of improving the productivity of the drug development process: Faster times and better decisions. Pharmacoeconomics 2002; 20:1-10
9. Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. JAMA 2014; 311:368-377
10. Epstein RA. The FDA's misguided regulation of stem-cell procedures: How administrative overreach blocks medical innovation. Manhattan Institute for Policy Research; September 2013. www.manhattan-institute.org/html/lpr_17.htm#.U7WTNPVOUdU
11. Candido KD, Knezevic NN, Chang Chien GC, Deer TR. The Food and Drug Administrations recent action on April 23, 2014 failed to appropriately address safety concerns about epidural steroid use. Pain Physician 2014; 17:E509-E524
12. Manchikanti L, Candido KD, Simopoulos T, Abdi S, Singh V, Gharibo CG, Boswell MV, Benyamin RM, Falco FJE, Helm II S, Grider JS, Diwan S, Staats PS, Hirsch JA. Epidural steroid warning controversy still dogging FDA. Pain Physician 2014; 17:E451-E474
13. U.S. Food and Drug Administration. News Release. FDA approves extendedrelease, single-entity hydrocodone product. October 25, 2013. www.fda.gov/newsevents/newsroom/pressannouncements/ucm372287.htm
14. Smith S. New pain pill's approval: Genuinely frightening. CNN Health, February 26, 2014. www.cnn.com/2014/02/26/health/zohydro-approval/
15. Loftus P. Doctors split on Zohydro, a longer-lasting painkiller. Wall Street Journal. May 26, 2014
16. McCarthy M. FDA chief defends Zohydro approval as US states rebel. BMJ 2014; 348:g2939
17. Letter to Margaret Hamburg, Commissioner, U.S. Food and Drug Administration, from The Fed Up! Coalition RE: New Drug Application NDA 202880, Zohydro ER, February 26, 2014
18. Olsen Y, Sharfstein JM. Chronic pain, addiction, and zohydro. N Engl J Med 2014 Apr 23. [Epub ahead of print].
19. McCarthy M. US bill would force FDA to withdraw approval of new pain drug Zohydro. BMJ 2014; 348:g2195
20. McCarthy M. FDA is urged to reverse its approval of new pain drug Zohydro ER. BMJ 2014; 348:g1894
21. House Appropriations/FDA Subcommittee Hearing RE: Act to Ban Zohydro, Thursday, March 27, 2014
22. Letter to Honorable Hal Rogers, United States House of Representatives, from American Society of Interventional Pain Physicians, RE: Support for The Act to Ban Zohydro, March 24, 2014
23. S.2134 -Act to Ban Zohydro, introduced by Senator Joe Manchin III, March 13, 2014
24. Murphy JP. Understanding the uproar over Zohydro ER. MedpageTODAY's Kevin-MD.com, March 30, 2014
25. Manchikanti L, Falco FJ, Hirsch JA. Opioid prescribing. Ann Intern Med 2014; 160:737
26. Manchikanti L, Abdi S, Atluri S, Balog CC, Benyamin RM, Boswell MV, Brown KR, Bruel BM, Bryce DA, Burks PA, Burton AW, Calodney AK, Caraway DL, Cash KA, Christo PJ, Damron KS, Datta S, Deer TR, Diwan S, Eriator I, Falco FJE, Fellows F, Geffert S, Gharibo CG, Glaser SE, Grider JS, Hameed H, Hameed M, Hansen H, Harned ME, Hayek SM, Helm II S, Hirsch JA, Janata JW, Kaye AD, Kaye AM, Kloth DS, Koyyalagunta D, Lee M, Malla Y, Manchikanti KN, McManus CD, Pampati V, Parr AT, Pasupuleti R, Patel VB, Sehgal N, Silverman SM, Singh V, Smith HS, Snook LT, Solanki DR, Tracy DH, Vallejo R, Wargo BW. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2 -Guidance. Pain Physician 2012; 15:S67-S116
27. Manchikanti L, Benyamin R, Datta S, Vallejo R, Smith HS. Opioids in chronic noncancer pain. Expert Rev Neurother 2010; 10:775-789
28. Manchikanti L, Helm II S, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician 2012; 15:ES9-ES38
29. United States hydrocodone and oxycodone consumption statistics as reported by the International Narcotics Board in 2012
30. Manchikanti L, Atluri S, Hansen H, Benyamin RM, Falco FJE, Helm II S, Kaye AD, Hirsch JA. Opioids in chronic noncancer pain: Have we reached a boiling point yet? Pain Physician 2014; 17:E1-E10
31. Centers for Disease Control and Prevention (CDC). Vital signs: Overdoses of prescription opioid pain relievers and other drugs among women-United States, 1999-2010. MMWR Morb Mortal Wkly Rep 2013; 62:537-542
32. United States Centers for Disease Control and Prevention. National Center for Injury Prevention and Control. Division of Unintentional Injury Prevention. Policy Impact: Prescription Painkiller Overdoses. November 2011. www.cdc.gov/homeandrecreationalsafety/pdf/policyimpact-prescriptionpainkillerod.pdf
33. Centers for Disease Control and Prevention (CDC). Vital Signs: Overdoses of prescription opioid pain relievers-United States, 1999-2008. MMWR Morb Mortal Wkly Rep 2011; 60:1487-1992
34. Kenan K, Mack, K, Paulozzi L. Trends in prescriptions for oxycodone and other commonly used opioids in the United States, 2000-2010. Open Medicine 2012; 6:E41
35. Atluri S, Sudarshan G, Manchikanti L. Assessment of the trends in medical use and misuse of opioid analgesics from 2004 to 2011. Pain Physician 2014; 17:E119-E128
36. Paulozzi LJ, Mack KA, Hockenberry JM. Vital Signs: Variation among states in prescribing of opioid pain relievers and benzodiazepines -United States, 2012. MMWR 2014; 63:1-6
37. Boudreau D, Von Korff M, Rutter CM, Saunders K, Ray GT, Sullivan MD, Campbell CI, Merrill JO, Silverberg MJ, Banta-Green C, Weisner C. Trends in long-term opioid therapy for chronic non-cancer pain. Pharmacoepidemiol Drug Saf 2009; 18:1166-1175
38. United Nations Office on Drugs and Crime. Ensuring availability of controlled medications for the relief of pain and preventing diversion and abuse: Striking the right balance to achieve the optimal public health outcome. Discussion paper based on a scientific workshop. UNODC, Vienna, Austria, January 18-19, 2011. www.unodc.org/docs/treatment/Pain/Ensuring_availability_of_controlled_medications_FINAL_15_March_CND_version.pdf
39. Thielke SM, Turner JA, Shortreed SM, Saunders K, Leresche L, Campbell CI, Weisner CC, Korff MV. Do patient-perceived pros and cons of opioids predict sustained higher-dose use? Clin J Pain 2014; 30:93-101
40. Centers for Disease Control and Prevention. CDC grand rounds: Prescription drug overdoses -a U.S. epidemic. MMWR Morb Mortal Wkly Rep 2012; 61:10-13
41. Jones CM, Mack KA, Paulozzi LJ. Pharmaceutical overdose deaths, United States, 2010. JAMA 2013; 309:657-659
42. United States Government Accountability Office: Report to Congressional Requesters. Prescription Pain Reliever Abuse, December 2011. www.gao.gov/assets/590/587301.pdf
43. Von Korff M. Commentary on Boscarino et al. Understanding the spectrum of opioid abuse, misuse and harms among chronic opioid therapy patients. Addiction 2010; 105:1783-1784
44. Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, Blow FC. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA 2011; 305:1315-1321
45. Atluri SL, Akbik H, Sudarshan G. Prevention of opioid abuse in chronic non-cancer pain: An algorithmic, evidence-based approach. Pain Physician 2012; 15:ES177-ES189
46. United States Centers for Disease Control and Prevention. Public Health Grand Rounds -Prescription drug overdoses: An American epidemic. February 18, 2011 www.cdc.gov/cdcgrandrounds/archives/2011/01-february.htm
47. Dublin S, Walker RL, Jackson ML, Nelson JC, Weiss NS, Von Korff M, Jackson LA. Use of opioids or benzodiazepines and risk of pneumonia in older adults: A population-based case-control study. J Am Geriatr Soc 2011; 59:1899-1907
48. Paulozzi LJ, Budnitz DS, Xi Y. Increasing deaths from opioid analgesics in the United States. Pharmacoepidemiol Drug Saf 2006; 15:618-627
49. Gomes T, Mamdani MM, Dhalla IA, Paterson JM, Juurlink DN. Opioid dose and drug-related mortality in patients with nonmalignant pain. Arch Int Med 2011; 171:686-691
50. Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M. Opioid prescriptions for chronic pain and overdose: A cohort study. Ann Int Med 2010; 152:85-92
51. Saunders KW, Dunn KM, Merrill JO, Sullivan M, Weisner C, Braden JB, Psaty BM, Von Korff M. Relationship of opioid use and dosage levels to fractures in older chronic pain patients. J Gen Int Med 2010; 25:310-315
52. Miller M, Sturmer T, Azrael D, Levin R, Solomon DH. Opioid analgesics and the risk of fractures in older adults with arthritis. J Am Geriatr Soc 2011; 59:430-438
53. Manchikanti L, Cash KA, Malla Y, Pampati V, Fellows B. A prospective evaluation of psychotherapeutic and illicit drug use in patients presenting with chronic pain at the time of initial evaluation. Pain Physician 2013; 16:E1-E13
54. Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies -Tackling the opioid-overdose epidemic. N Engl J Med 2014 Apr 23. [Epub ahead of print].
55. Lee D, Armaghani S, Archer KR, Bible J, Shau D, Kay H, Zhang C, McGirt MJ, Devin C. Preoperative opioid use as a predictor of adverse postoperative self-reported outcomes in patients undergoing spine surgery. J Bone Joint Surg Am 2014; 96:e89
56. Beaudoin FL, Straube S, Lopez J, Mello MJ, Baird J. Prescription opioid misuse among ED patients discharged with opioids. Am J Emerg Med 2014; 32:580-585
57. Svendsen K, Fredheim OM, Romundstad P, Borchgrevink PC, Skurtveit S. Persistent opioid use and socio-economic factors: A population-based study in Norway. Acta Anaesthesiol Scand 2014; 58:437-445
58. Degenhardt L, Charlson F, Mathers B, Hall WD, Flaxman AD, Johns N, Vos T. The global epidemiology and burden of opioid dependence: Results from the global burden of disease 2010 study. Addiction 2014 Mar 25. [Epub ahead of print].
59. Helmerhorst GT, Vranceanu AM, Vrahas M, Smith M, Ring D. Risk factors for continued opioid use one to two months after surgery for musculoskeletal trauma. J Bone Joint Surg Am 2014; 96:495-499
60. Berecki-Gisolf J, Collie A, McClure RJ. Prescription opioids for occupational injury: Results from workers' compensation claims records. Pain Med 2014 Mar 18. [Epub ahead of print].
61. Sites BD, Beach ML, Davis MA. Increases in the use of prescription opioid analgesics and the lack of improvement in disability metrics among users. Reg Anesth Pain Med 2014; 39:6-12
62. Degenhardt L, Whiteford HA, Ferrari AJ, Baxter AJ, Charlson FJ, Hall WD, Freedman G, Burstein R, Johns N, Engell RE, Flaxman A, Murray CJ, Vos T. Global burden of disease attributable to illicit drug use and dependence: Findings from the Global Burden of Disease Study 2010. Lancet 2013; 382:1564-1574
63. Sehgal N, Colson J, Smith HS. Chronic pain treatment with opioid analgesics: Benefits versus harms of long-term therapy. Expert Rev Neurother 2013; 13:1201-1220
64. Krumova EK, Bennemann P, Kindler D, Schwarzer A, Zenz M, Maier C. Low pain intensity after opioid withdrawal as a first step of a comprehensive pain rehabilitation program predicts long-term nonuse of opioids in chronic noncancer pain. Clin J Pain 2013; 29:760-769
65. Ashworth J, Green DJ, Dunn KM, Jordan KP. Opioid use among low back pain patients in primary care: Is opioid prescription associated with disability at 6-month follow-up? Pain 2013; 154:1038-1044
66. Radcliff K, Freedman M, Hilibrand A, Isaac R, Lurie JD, Zhao W, Vaccaro A, Albert T, Weinstein JN. Does opioid pain medication use affect the outcome of patients with lumbar disc herniation? Spine (Phila Pa 1976) 2013; 38:E849-E860
67. Glazier RE, Kling RN. Recent trends in substance abuse among persons with disabilities compared to that of persons without disabilities. Disabil Health J 2013; 6:107-115
68. Johnson EM, Lanier WA, Merrill RM, Crook J, Porucznik CA, Rolfs RT, Sauer B. Unintentional prescription opioid-related overdose deaths: Description of decedents by next of kin or best contact, Utah, 2008-2009. J Gen Intern Med 2013; 28:522-529
69. Jamison RN, Edwards RR, Liu X, Ross EL, Michna E, Warnick M, Wasan AD. Relationship of negative affect and outcome of an opioid therapy trial among low back pain patients. Pain Pract 2013; 13:173-181
70. Franklin GM, Mai J, Turner J, Sullivan M, Wickizer T, Fulton-Kehoe D. Bending the prescription opioid dosing and mortality curves: Impact of the Washington State opioid dosing guideline. Am J Ind Med 2012; 55:325-331
71. Cifuentes M, Powell R, Webster B. Shorter time between opioid prescriptions associated with reduced work disability among acute low back pain opioid users. J Occup Environ Med 2012; 54:491-496
72. FDA Commissioner Margaret A. Hamburg statement on prescription opioid abuse. Silver Spring, MD, Food and Drug Administration, April 3, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391590.htm
73. Institute of Medicine (IOM). Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. The National Academies Press, Washington, DC, June 29, 2011. www.iom.edu/~/media/Files/Report%20Files/2011/Relieving-Pain-in-America-ABlueprint-for-Transforming-Prevention-Care-Education-Research/Pain%20Research%202011%20Report%20Brief.pdf
74. Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain 2012; 13:715-724
75. Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD. Expenditures and health status among adults with back and neck problems. JAMA 2008; 299:656-664. Erratum in: JAMA 2008; 299:2630
76. Martin BI, Turner JA, Mirza SK, Lee MJ, Comstock BA, Deyo RA. Trends in health care expenditures, utilization, and health status among US adults with spine problems, 1997-2006. Spine (Phila Pa 1976) 2009; 34:2077-2084
77. United States Government Accountability Office: Report to Congressional Requesters. Nurse Anesthetists Billed for Few Chronic Pain Procedures; Implementation of CMS Payment Policy Inconsistent. February 2014. www.gao.gov/assets/670/660740.pdf
78. Fauber J. MedPage Today/Milwaukee Journal Sentinel series triggers senate investigation. Medpage Today, May 9, 2012
79. FDA Center for Drug Evaluation and Research, Summary Review for Regulatory Action RE: Zohydro ER, Division Director's Review and Summary Basis for Approval, October 25, 2013
80. Manchikanti L, Singh V, Caraway DL, Benyamin RM. Breakthrough pain in chronic non-cancer pain: Fact, fiction, or abuse. Pain Physician 2011; 14:E103-E117
81. www.tylenolprofessional.com/acetaminophen-safety.html
82. Manchikanti L, Hirsch JA, Cohen SP, Heavner JE, Falco FJE, Diwan S, Boswell MV, Candido KD, Onyewu O, Zhu J, Sehgal N, Kaye AD, Benyamin RM, Helm II S, Singh V, Datta S, Abdi S, Christo PJ, Hameed H, Hameed M, Vallejo R, Pampati V, Racz GB, Raj PP. Assessment of methodologic quality of randomized trials of interventional techniques: Development of an interventional pain management specific instrument. Pain Physician 2014; 17:E263-E290.