Post-marketing experience with an opioid nasal spray for migraine: Lessons for the future

Cephalalgia

Volumn 26, Issue 2, 2006, Pages 89-97

  Loder, E ^a,b  

^a HARVARD MEDICAL SCHOOL   (United States)

^b and Red Sox Foundation and Massachusetts General Hospital Home Base Program   (United States)

Author keywords

Addiction; Butorphanol nasal spray; Migraine; Postmarketing surveillance

Indexed keywords

BUTORPHANOL;

CLINICAL TRIAL; DISEASE COURSE; DISEASE EXACERBATION; DRUG DELIVERY SYSTEM; DRUG FORMULATION; FOOD AND DRUG ADMINISTRATION; HUMAN; MIGRAINE; NEUROTOXICITY; REVIEW; RISK ASSESSMENT; SIDE EFFECT; UNITED STATES;

ADMINISTRATION, INTRANASAL; ANALGESICS, OPIOID; BUTORPHANOL; DRUG APPROVAL; FORECASTING; HUMANS; MIGRAINE DISORDERS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33644964729     PISSN: 03331024     EISSN: 14682982     Source Type: Journal    
DOI: 10.1111/j.1468-2982.2005.00951.x     Document Type: Review

References (50)

1. Gillis JC Benfield P Goa KL. Transnasal butorphanol. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in acute pain management Drugs 1995 50 157 75
2. Fisher MA Glass S. Butorphanol (Stadol): a study in problems of current drug information and control Neurology 1997 48 1156 60
3. Controlled Substances Act, Title II, Section 801. Comprehensive Drug Abuse Prevention and Control Act of 1970
4. Evans WS Bowen JN Gordano FL Clark B A case of stadol dependence JAMA 1985 253 2191 2
5. Brown GR. Stadol dependence: another case JAMA 1985 254 910
6. Smith SG Davis WM. Nonmedical use of butorphanol and diphenhydramine JAMA 1984 252 1010
7. Migraine drug can be addictive Beloit Daily News Monday 16 June 1997
8. Migraines, stadol, addiction and more Des Moines Register 16 June 1997 2a
9. Frankel A. ATLA's War Room The American Lawyer 16 October 2000
10. Accessed at on 28 January 2004
11. Accessed at on 6 December 2004.
12. Accessed at on 6 December 2004.
13. Accessed at. on 5 December 2004
14. Butorphanol now in Schedule IV Pharm Today 1997 3 1
15. Gilman AG Goodman LS Gilman A. The pharmacological basis of therapeutics 6th edn New York Macmillan Publishing Co. 1980 494
16. Drug Abuse Advisory Committee, FDA, 1 June 1978. Proceedings obtainable through the Freedom of Information Act. Reported by Fisher MA et al. (see Footnote 3).
17. Jasinski DR Preston KL. Abuse liability of butorphanol Bristol-Myers report CHU-G-23505 1988
18. Sullivan JT Preston KL Testa MP Jasinski DR. Relative abuse liability and pharmacodynamics of transnasal and intramuscular butorphanol NIDA Res Monogr 1991 105 452
19. Jaskinski DR. Human pharmacology of narcotic antagonists J Clin Pharmacol 1979 7 287S 290S
20. Caplan LR Thomas C Banks G. Central nervous system complications of addiction to 'T's and blues' Neurology 1982 32 623 828
21. United States Code. 21 USC 811(b). 1997
22. Public Citizen Comments on Stadol. Public Citizen's Health Research Group's comments on: Schedules of Controlled Substances: Proposed Placement of Butorphanol into Schedule IV The Consumer Law News August 11 1997.
23. Gillis JC Benfield P Goa KL. Transnasal butorphanol: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in acute pain management Drugs 1995 50 157 75
24. Preston KL Sullivan JT Testa M Jasinski DR Psychopharmacology and abuse potential of transnasal butorphanol Alc Drug Depend 1994 35 159 67
25. Smith SG Davis WM. Non-medical use of butorphanol and diphenhydramine JAMA 1984 252 1010
26. Austin RP. Diversion of butorphanol Am J Hosp Pharm 1983 40 1306
27. Butorphanol nasal spray package insert Physician's desk reference edition 55th edn. Montvale Medical Economics Co. 2001
28. Brands B Sproule B Marshman J, eds. Drugs and drug abuse - a reference text 3rd edn Toronto Addiction Research Foundation 1998
29. Hoffert MJ Couch JR Diamond S Elkind AH Goldstein J Kohlerman NJ et al. Transnasal butorphanol in the treatment of acute migraine Headache 1995 35 65 9
30. Robbins L. Letter to the editor Headache 1994 33 220
31. 'Spray's claims false, suit says' Augusta Chronicle 7 March 1998
32. 183 F.R.D. 520 (N.D. Ill 1998). Decided 18 November 1998
33. Stadol advertisement N Engl J Med 1998 323 338
34. Package insert for butorphanol nasal spray Physician's desk reference Montvale Medical Economics Co. 2002
35. ®) in the outpatient treatment of severe pain from migraine headache. Presented at the American Pain Society 22nd Annual Scientific Meeting, Chicago, 20-23 March, 2003
36. Singer RS Actiq (Oral fentanyl citrate) in the outpatient treatment of ER-bound migrane patients Headache 2004 42 40
37. Landy S. Oral transmucosal fentanyl citrate (OTFC) for the outpatient treatment of migraine headache pain. Abstract presented at the 22nd Annual Scientific Meeting of the American Pain Society 20-23 March 2003
38. Prescribing information for oral transmucosal fentanyl citrate. Accessed at on 28 January 2004
39. Therapeutic spotlight: crisis management of severe migraine. Alternatives to emergency room care Neurol Rev Suppl. August 2003
40. Singer RS Oral transmucosal fentanyl citrate in the outpatient treatment of severe pain from migraine headaches The Pain Clinic 2004 6 10 13
41. Loder E. Opioids in chronic nonmalignant pain - has the pendulum swung too far? N Engl Pain Assoc Newsletter 1999 4 14
42. Saper JR. The role of chronic opioid therapy in managing chronic daily headache: a roundtable discussion. Presented at the Annual Scientific Meeting of the American Headache Society, Seattle, WA, 2002
43. Rothrock J. The role of chronic opioid therapy in managing chronic daily headache: a roundtable discussion. Presented at the Annual Scientific Meeting of the American Headache Society, Seattle, WA, 2002
44. Mao J Sung B Ji R Lim G Chronic morphine induces down regulation of spinal glutamate transporters: implications in morphine tolerance and abnormal pain sensitivity J Neurosci 2002 22 8312 23
45. Mao J Sung B Ru-Rong J Lim G Neuronal apoptosis associated with morphine tolerance: evidence for an opioid-induced neurotoxic mechanism J Neurosci 2002 22 7650 61
46. Robbins L. Tramadol for tension-type headache. Letter to the editor Headache 2004 44 192 3
47. MaassenVanDenBrink A Reekers M Bax WA Ferrari MD Saxena PR. Coronary side-effect potential of current and prospective antimigraine drugs Circulation 1998 98 25 30
48. Wood AJJ. Thrombotic thrombocytopenic purpura and clopidogrel - a need for new approaches to drug safety (Editorial) N Engl J Med 2000 342 1824 6
49. Accessed at on 29 June 2005
50. Accessed at on 29 June 2005