Food and drug administration's obesity drug guidance document: A short history

Circulation

Volumn 125, Issue 17, 2012, Pages 2156-2164

  Colman, Eric ^a  

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

Author keywords

Cholesterol; Diabetes mellitus, type 2; Hypertension; Lipids; Obesity

Indexed keywords

ANTILIPEMIC AGENT; ANTIOBESITY AGENT; DEXFENFLURAMINE; FENFLURAMINE; LEPTIN; METHAMPHETAMINE; PHENTERMINE; PLACEBO; RIMONABANT; SIBUTRAMINE; TETRAHYDROLIPSTATIN;

ADVISORY COMMITTEE; BODY MASS; CARDIOVASCULAR DISEASE; DISEASE ASSOCIATION; DRUG APPROVAL; DRUG EFFICACY; FOOD AND DRUG ADMINISTRATION; HUMAN; LIFESTYLE MODIFICATION; LONG TERM CARE; OBESITY; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; WEIGHT GAIN; WEIGHT REDUCTION;

ADOLESCENT; ADULT; ADVISORY COMMITTEES; AGED; ANTI-OBESITY AGENTS; BARIATRIC MEDICINE; BODY MASS INDEX; CHILD; CONGRESSES AS TOPIC; CYCLOBUTANES; DIABETES MELLITUS, TYPE 2; DRUG APPROVAL; DRUG DISCOVERY; FEMALE; HISTORY, 20TH CENTURY; HISTORY, 21ST CENTURY; HUMANS; MALE; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; OBESITY; OUTCOME ASSESSMENT (HEALTH CARE); PIPERIDINES; PRACTICE GUIDELINES AS TOPIC; PYRAZOLES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REFERENCE STANDARDS; SAFETY-BASED DRUG WITHDRAWALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84860330219     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.111.028381     Document Type: Review

References (76)

1. Ogden C, Carrol M, Curtin L, McDowell M, Tabak C, Flegal K. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006;295:1549-1555.
2. Brown C, Higgins M, Donato K, Rohde F, Garrison R, Obarzanek E, Ernst N, Horan M. Body mass index and the prevalence of hypertension and dyslipidemia. Obes Res. 2000;8:605-619.
3. Wilson P, D'Agostino R, Sullivan L, Parise H, Kannel W. Overweight and obesity as determinants of cardiovascular risk: the Framingham experience. Arch Intern Med. 2002;162:1867-1872.
4. Poirier P, Giles T, Bray G, Hong Y, Stern J, Pi-Sunyer X, Eckel R. Obesity and cardiovascular disease: pathophysiology, evaluation, and effect of weight loss. Circulation. 2006;113:898-918.
5. Basen-Engquist K, Chang M. Obesity and cancer risk: recent review and evidence. Curr Oncol Rep. 2011;13:71-76.
6. Manninen P, Riihimaki H, Heliovaara M, Makela P. Overweight, gender, and knee osteoarthritis. Int J Obes Relat Metab Disord. 1996;20:595-597.
7. Gabay O, Berenbaum F. Adipokines in arthritis: new kids on the block. Curr Rheum Dis. 2009;5:226-232.
8. Ferini-Strambi L, Fantini ML, Castronovo C. Epidemiology of obstructive sleep apnea syndrome. Minerva Med. 2004;95:187-202.
9. Puhl R, Heuer C. The stigma of obesity: a review and update. Obesity (Silver Spring). 2009;17:941-964.
10. Trogdon J, Finkelstein E, Feagan C, Cohen J. State-and payer-specific estimates of annual medical expenditures attributable to obesity. Obesity (Silver Spring). 2012;20:214-220.
11. Colman E. Anorectics on trial: a half-century of federal regulation of prescription appetite suppressants. Ann Intern Med. 2005;143:380-385.
12. Rasmussen N. America's first amphetamine epidemic 1929-1971. Am J Public Health. 2008;98:974-985.
13. Health implications of obesity: National Institutes of Health Consensus Development Conference. Ann Intern Med. 1985;103:981-982.
14. Zhang Y, Proenca R, Maffei M, Barone M, Leopold L, Friedman JM. Positional cloning of the mouse obese gene and its human homologue. Nature. 1994;372:425-432.
15. US Food and Drug Administration. Proceedings of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting. Silver Spring, MD: US Food and Drug Administration; 1995.
16. Bray G. Presented at: Endocrinologic and Metabolic Drugs Advisory Committee Meeting; January 19-20, 1995; Silver Spring, MD.
17. Darga L, Carrol-Michals L, Botsford S, Lucas C. Fluoxetine's effect on weight loss in obese subjects. Am J Clin Nutr. 1991;54:321-325.
18. Guy-Grand B, Crepald G, Lefebvre P, Apfelbaum M, Gries A, Turner P. International trial of long-term dexfenfluramine in obesity. Lancet. 1989; 2:1142-1145.
19. Weintraub M. Long-term weight control study: conclusions. Clin Pharmacol Ther. 1992;51:642-646.
20. Cara J. Presented at: Endocrinologic and Metabolic Drugs Advisory Committee Meeting; January 19-20, 1995; Silver Spring, MD.
21. Siris E. Presented at: Endocrinologic and Metabolic Drugs Advisory Committee Meeting; January 19-20, 1995; Silver Spring, MD.
22. Troendle G. Presented at: Endocrinologic and Metabolic Drugs Advisory Committee Meeting; January 19-20, 1995; Silver Spring, MD.
23. US Food and Drug Administration. 1996 Guidelines for the Clinical Evaluation of Weight-Control Drug. Silver Spring, MD: US Food and Drug Administration; 1996.
24. Burton B, Foster W, Hirsch J, Van Itallie T. Health implications of obesity: an NIH consensus development conference. Int J Obes. 1985; 85:155-169.
25. Goldstein D. Beneficial health effects of modest weight loss. Int J Obes. 1992;16:397-415.
26. US Food and Drug Administration. Medical officer review of dexfenfluramine. 1995. New Drug Application No. 20-344.
27. US Food and Drug Administration. Medical officer review of sibutramine 1996. New Drug Application No. 20-632; 1996.
28. US Food and Drug Administration. Medical officer review of orlistat. 1999. New Drug Application No. 20-766.
29. Davis R, Faulds D. Dexfenfluramine: an updated review of its therapeutic use in the management of obesity. Drugs. 1996;52:696-724.
30. Rossner S, Sjostrom L, Noack R, Meinders A, Noseda G. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity: European Orlistat Obesity Study Group. Obes Res. 2000;8:49-61.
31. McNeely W, Goa K. Sibutramine. A review of its contribution to the management of obesity. Drugs. 1998;56:1093-1124.
32. Ricaurte G, Molliver M, Martello M, Katz J, Wilson M, Martello A. Dexfenfluramine neurotoxicity in brains of non-human primates. Lancet. 1991;338:1487-1488.
33. Abenhaim L, Moride Y, Brenot F, Rich S, Benichou J, Kurz X, Higenbottam T, Oakley C, Wouters E, Aubier M, Simonneau G, Begaud B. Appetite-suppressant drugs and the risk of primary pulmonary hypertension: International Primary Pulmonary Hypertension Study Group. N Engl J Med. 1996;335:609-616.
34. US Food and Drug Administration. Proceedings of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting. Silver Spring, MD: US Food and Drug Administration; 1995.
35. Melia A, Koss-Twardy S, Zhi J. The effect of orlistat, an inhibitor of dietary fat absorption, on the absorption of vitamins A and E in healthy volunteers. J Clin Pharmacol. 1996;36:647-653.
36. Zhi J, Melia A, Koss-Twardy S, Arora S, Patel I. The effect of orlistat, an inhibitor of dietary fat absorption, on the pharmacokinetics of betacarotene in healthy volunteers. J Clin Pharmacol. 1996;36:152-159.
37. Connolly H, Crary J, McGoon M, Hensrud D, Edwards B, Edwards W, Schaff H. Valvular heart disease associated with fenfluraminephentermine. N Engl J Med. 1997;337:581-588.
38. FDA announces withdrawal fenfluramine and dexfenfluramine. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/ucm179871.htm. Accessed July 6, 2011.
39. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: Public Health Service. Bethesda, MD: National Institutes of Health, National Heart, Lung, and Blood Institute; 1998. NIH publication No. 98-4083.
40. World Health Organization. Physical status: the use and interpretation of anthropometry: report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
41. Manson J, Stampfer M, Hennekens C, Willet W. Body weight and longevity: a reassessment. JAMA. 1987;257:353-358.
42. Troiano R, Frongillo E, Sobal J, Levisky D. The relationship between body weight and mortality: a quantitative analysis of combined information from existing studies. Int J Obes Relat Metab Disord. 1996;1: 63-75.
43. US Food and Drug Administration. Proceedings of the Endocrinologic and Metabolic Drugs Advisory Committee. Silver Spring, MD: US Food and Drug Administration; 2004.
44. Flegal K. Presented at: Endocrinologic and Metabolic Drugs Advisory Committee Meeting; September 8, 2004; Silver Spring, MD.
45. Atkinson R. Presented at: Endocrinologic and Metabolic Drugs Advisory Committee Meeting; September 8, 2004; Silver Spring, MD.
46. Wierman M. Presented at: Endocrinologic and Metabolic Drugs Advisory Committee Meeting; September 8, 2004; Silver Spring, MD.
47. US Food and Drug Administration. Developing products for weight management: draft guidance. http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/ucm064981.htm. Accessed July 6, 2011.
48. Hauptman J, Lucas C, Boldrin M, Collins H. Orlistat in the long-term treatment of obesity in primary care settings. Arch Fam Med. 2000;9: 160-167.
49. Diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention: draft guidance. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM071624. pdf. Accessed October 28, 2011.
50. Diabetes mellitus: evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM071627.pdf. Accessed October 28, 2011.
51. Fixed-combination prescription drugs for humans. Code of Federal Regulations. Title 21, Pt 300.50, 2011.
52. Baptista T, Zarate J, Joober R, Colasante C, Beaulieu S, Paez X, Hernandez L. Drug-induced weight gain, an impediment to successful pharmacotherapy: focus on antipsychotics. Curr Drug Targets. 2004;5: 279-299.
53. Newcomer J. Second-generation antipsychotics and metabolic effects: a comprehensive literature review. CNS Drugs. 2005;19(suppl 1):1-93.
54. McDonagh M, Peterson K, Carson S, Fu R, Thakurta S. Drug Class Review: Atypical Antipsychotic Drugs: Final Update 3 Report. Portland, OR: Oregon Health and Science University; 2010.
55. Seghatol F, Rigolin V. Appetite suppressants and valvular heart disease. Curr Opin Cardiol. 2002;17:486-492.
56. Fitzgerald L, Burn T, Brown B, Patterson J, Corjay M, Valentine P, Sun J, Link J, Abbaszade I, Hollis J, Largent B, Hartig P, Hollis P, Meunier P, Robichaud A, Robertson D. Possible role of valvular serotonin 5-HT(2B) receptors in the cardiopathy associated with fenfluramine. Mol Pharmacol. 2000;57:75-81.
57. Pagotto U, Marsicano G, Cota D, Lutz B, Pasquali R. The emerging role of the endocannabinoid system in endocrine regulation and energy balance. Endocr Rev. 2006;27:73-100.
58. US Food and Drug Administration. Briefing Document for the Endocrinologic and Metabolic Drugs Advisory Committee Meeting. Silver Spring, MD: US Food and Drug Administration; June 13, 2007.
59. US Food and Drug Administration. Transcript for the Endocrinologic and Metabolic Drugs Advisory Committee Meeting; Silver Spring, MD: US Food and Drug Administration; June 13, 2007.
60. European Medicines Agency. Public statement on Accomplia (rimonabant). Withdrawal of the marketing authorization in the European Union. http://www.ema.europa.eu/docs/en-GB/document-library/Public-statement/2009/11/ WC500012189.pdf. Accessed April 8, 2012.
61. Topol E, Bousser M, Fox K, Creager M, Despres J, Easton J, Hamm C, Montalescot G, Steg P, Pearson T, Cohen E, Gaudin C, Job B, Murphy J, Bhatt D. Rimonabant for Prevention of Cardiovascular Events (CRESCENDO): a randomized, multicentre, placebo-controlled trial. Lancet. 2010;376:517-523.
62. Jame W, Caterson I, Coutinho W, Finer N, Van Gall L, Maggioni A, Torp-Pedersen C, Sharma A, Shepard G, Rode R, Renz C. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med. 2010;363:905-917.
63. US Food and Drug Administration. Transcript for the Endocrinologic and Metabolic Drugs Advisory Committee Meeting. Silver Spring, MD: US Food and Drug Administration; September 15, 2010.
64. US Food and Drug Administration. Transcript for the Endocrinologic and Metabolic Drugs Advisory Committee Meeting. Silver Spring, MD: US Food and Drug Administration; September 15, 2010.
65. Norris S, Zhang X, Avenell A, Gregg E, Schmid C, Lau J. Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2005:CD004095.
66. Ferland A, Poirier P, Series F. Sibutramine versus continuous positive airway pressure in obese obstructive sleep apnea patients. Eur Respir J. 2009;34:694-701.
67. Lindholm A, Bixo M, Bjorn I, Wolner-Hanssen P, Eliasson M, Larsson A, Johnson O, Poromaa I. Effect of sibutramine on weight reduction in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2008;89:1221-1228.
68. Di Francesco V, Sacco T, Zamboni M, Bissoli L, Zoico E, Mazzali G, Minniti A, Salanitri T, Cancelli F, Bosello O. Weight loss and quality of life improvements in obese subjects treated with sibutramine: a double-blind randomized multicenter study. Ann Nutr Metab. 2007;51: 75-81.
69. Memorandum to the file, NDA 20-632, Meridia (sibutramine hydrochloride monohydrate). October 4, 2010. http://www.fda.gov/downloads/Drugs/DrugSafety/ UCM228795.pdf. Accessed July 6, 2011.
70. Abbott to voluntarily withdraw Meridia (sibutramine) in the U.S. http://www.abbott.com/news-media/press-releases/Press-Release-0908.htm. Accessed April 8, 2012.
71. Availability for public disclosure of data and information in an application or abbreviated application. Code of Federal Regulations. Title 21, Pt 314.430 (d)(1).
72. US Food and Drug Administration. Proceedings From the Endocrinologic and Metabolic Drugs Advisory Committee Meeting. http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM224180.pdf. Accessed October 20, 2011.
73. US Food and Drug Administration. Proceedings from the Endocrinologic and Metabolic Drugs Advisory Committee Meeting. http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM232443.pdf. Accessed October 20, 2011.
74. US Food and Drug Administration. Proceedings from the Endocrinologic and Metabolic Drugs Advisory Committee Meeting. http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM239926.pdf. Accessed October 20, 2011.
75. Powell A, Apovian C, Aronne L. New drug targets for the treatment of obesity. Clin Pharmacol Ther. 2011;90:40-51.
76. McCallister E. Obesity reset. Biocentury. http://www.biocentury.com/ promotions/obesity/next-generation-of-obesity-drugs-unlikely-to-reachregulators- before-2014.htm. Accessed April 8, 2012.