Академический Документы
Профессиональный Документы
Культура Документы
The Amphetamines
Lesses, M.F. and Myerson A. Benzedrine sulfate as an aid in the treatment of obesity. 1938 New Engl J Med; 218:119124 Benzedrine (amphetamine sulfate) approved by the FDA in 1939 Desoxyephedrine approved in 1943 Obesity indication for desoxyephedrine approved in 1947 The sympathomimetic amines have been found of value, when administered under the supervision of a physician, as an adjunct to the dietary management of obesity warned against its use in persons with cardiovascular disease, hypertension, or insomnia and in those who were neurotic or hyperexcitable. Amphetamines: amphetamine sulfate, desoxyephedrine (methamphetamine), dextroamphetamine, amphetamine + barbiturate
Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004
An Epidemic
Widespread illicit use and abuse of amphetamines 1958 3.5 billion tablets 1967 8 billion tablets 1967 23 million prescriptions (80% female) Most commonly prescribed for obesity Drug Abuse Control Amendments of 1965 Increased record keeping throughout the system of manufacture, distribution, prescription, and sale Controlled Substances Act of 1970 Schedules 1-5
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Phentermine + Fenfluramine
Phentermine stimulant Fenfluramine sedative Long-term studies in the 1980s by Weintraub et al. The rise of Phen-Fen
1992
1996
Phentermine
Fenfluramine
2,000,000
69,000
Committee
11,000,000
7,000,000
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Regulatory Shift
1992 regulatory responsibility for obesity drugs transferred from the Division of Neuropharmacology Drugs to the Division of Metabolic and Endocrine Drugs Effective drug treatment requires long-term or indefinite use Pre-approval studies should therefore be long-term Jan. 1995 Advisory Committee discusses the Obesity Guidance document
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Summary
Benefits: defining or quantitating the efficacy of weight-loss drugs has been problematic 1940s-1960s: ???? 1960s: statistically significantly more weight loss 1990s: clinically significant weight loss is 5% Risks: safety issues have dominated the regulatory history of the weight-loss drugs Illicit use and abuse Primary pulmonary hypertension Cardiac valvulopathy Blood pressure and pulse
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Conclusion
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