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DRUG RECORD

 

DIETHYLPROPION

OVERVIEW
Diethylpropion

 

Introduction

Diethylpropion is a sympathomimetic amine and anorectic agent used for the short-term therapy of obesity. Diethylpropion has not been linked to either serum enzyme elevations or to clinically apparent acute liver injury.

 

Background

Diethylpropion (Dye eth" il proe' pee on) is a structural analogue to amphetamine and has similar activity in suppressing appetite, but has few of the other central nervous system effects of amphetamines and less abuse potential. Diethylpropion was approved as a therapy for obesity in the United States in 1959 and is recommended only for short-term use (less than 12 weeks). Diethylpropion is available by prescription as 25 mg immediate-release and 75 mg controlled release tablets in generic forms and formerly under the trade name Tenuate. The usual dose is 75 mg daily either as 25 mg (immediate-release) 1 hour before meals or 75 mg (controlled-release) once daily. Diethylpropion is a Schedule IV controlled substance, meaning that it has a proven but low potential for abuse and has an accepted medical use. Common side effects include nervousness, excitability, insomnia, headache, dry mouth, sweating, nausea, constipation, and thirst. Rare severe adverse events include atrial fibrillation, acute psychosis and pulmonary hypertension.

 

Hepatotoxicity

Diethylpropion has not been linked to an increased rate of serum enzyme elevations during therapy; however, actual results of ALT monitoring during diethylpropion therapy have rarely been reported. Despite long-term availability and wide use of diethylpropion, there have been no published reports linking it to clinically apparent acute liver injury.

 

Mechanism of Injury

The safety of diethylpropion is perhaps linked to its rapid urinary excretion. Nevertheless, it is extensively metabolized in the liver and some of the metabolites are biologically active.


 

Drug Class: Weight Loss Agents

 

 

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PACKAGE INSERT
PRODUCT INFORMATION
Weight Loss Agents

 

SUMMARY & COMPLETE LABELING
Diethylpropion

 

REPRESENTATIVE TRADE NAMES
Diethylpropion – Generic, Tenuate®

DRUG CLASS
Weight Loss Agents

COMPLETE LABELING

FDA product labeling at DailyMed, National Library of Medicine, NIH

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CHEMICAL FORMULA AND STRUCTURE
Weight Loss Agents

 

DRUG CAS REGISTRY NUMBER MOLECULAR FORMULA STRUCTURE
Diethylpropion 90-84-6 C13-H19-N-O Diethylpropion Chemical Structure

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REFERENCES
Diethylpropion

 

References Last Updated: 22 July 2013

  1. Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 483-91.  (Expert review of hepatotoxicity published in 1999; diethylpropion is not discussed).

  2. Westfall TC, Westfall DP. Adrenergic agonists and antagonists. In, Brunton LL, Chabner BA, Knollman BC, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill, 2011, pp. 277-334. (Textbook of pharmacology and therapeutics; diethylpropion is discussed as a sympathomimetic agent used for weight loss).

  3. Carney DE, Tweddell ED. Double blind evaluation of long acting diethylpropion hydrochloride in obese patients from a general practice. Med J Aust 1975; 1: 13-5. PubMed Citation  (102 obese patients enrolled in controlled trial of diethylpropion vs placebo for 16 weeks with subsequent cross-over; there were no serious adverse events and side effects were mild and transient; no mention of ALT elevations or hepatotoxicity).

  4. Altschuler S, Conte A, Sebok M, Marlin RL, Winick C. Three controlled trials of weight loss with phenylpropanolamine. Int J Obes 1982; 6: 549-56. PubMed Citation  (Controlled trial of phenylpropanolamine-caffeine vs placebo vs mazindol vs diethylpropion in 201 obese patients; adverse reactions included dry mouth, diarrhea, constipation and diuresis; no serious adverse events and no mention of ALT elevations or hepatotoxicity).

  5. Parsons WB Jr. Controlled-release diethylpropion hydrochloride used in a program for weight reduction. Clin Ther 1981; 3: 329-35. PubMed Citation  (49 obese patients were treated with placebo vs diethylpropion for 12 weeks; side effects included headaches, dry mouth, nervousness and nausea; no serious adverse events or liver injury occurred; ALT monitoring was not done).

  6. Bray GA. A concise review on the therapeutics of obesity. Nutrition 2000 16: 953-60. PubMed Citation  (Review of drug treatment of obesity; hepatotoxicity is not discussed).

  7. Haddock CK, Poston WS, Dill PL, Foreyt JP, Ericsson M. Pharmacotherapy for obesity: a quantitative analysis of four decades of published randomized clinical trials. Int J Obes Relat Metab Disord 2002; 26: 262-73. PubMed Citation  (Meta-analysis of published studies of anti-obesity medications; diethylpropion was evaluated in 13 studies published between 1965-83; no discussion of side effects).

  8. Colman E. Anorectics on trial: a half century of federal regulation of prescription appetite suppressants. Ann Intern Med 2005; 143: 380-5. PubMed Citation  (History of the approval of medications for obesity from initial agents approved in 1947 to sibutramine in 1997; diethylpropion was first approved in 1959, before the Kefauver-Harris amendment requiring proof of efficacy from controlled trials).

  9. Li Z, Maglione M, Tu W, Mojica W, Arterburn D, Shugarman LR, Hilton L, et al. Meta-analysis: pharmacologic treatment of obesity. Ann Intern Med 2005; 142: 532-46. PubMed Citation  (Systematic review of efficacy and safety of medications for obesity; diethylpropion was evaluated in 9 placebo-controlled trials of therapy for 6 to 52 weeks and was associated with modest additional weight loss; no data on adverse events were reported but evidently there were no serious adverse events attributed to therapy).

  10. Bray GA. Drug Insight: appetite suppressants. Nat Clin Pract Gastroenterol Hepatol 2005; 2: 89-95. PubMed Citation  (Review of the mechanism of action and clinical efficacy of drugs that suppress appetite including sympathomimetic agents [amphenatmine, phentermine, sibutramine], serotonin reuptake inhibitors [bupropion, fenfluramine, fluoxetine], GABAergic agents [topiramate, zonisamide], cannabinoid antagonists [rimonabant] and various peptides [leptin, neuropeptide Y, melanocortin-4]). 

  11. Ioannides-Demos LL, Proietto J, Tonkin AM, McNeil JJ. Safety of drug therapies used for weight loss and treatment of obesity. Drug Saf 2006; 29: 277-302. PubMed Citation  (Review of safety of drug therapy of obesity; the only mention of liver adverse events was “a case of reversible hepatotoxicity associated with sibutramine”). 

  12. Cercato C, Roizenblatt VA, Leança CC, Segal A, Lopes Filho AP, Mancini MC,Halpern A. A randomized double-blind placebo-controlled study of the long-term efficacy and safety of diethylpropion in the treatment of obese subjects. Int J Obes (Lond) 2009;33: 857-65. PubMed Citation(Randomized controlled trial of diethylpropion vs placebo for 24 weeks and open label use thereafter; common side effects were dry mouth, insomnia, constipation, headache and dizziness; no serious adverse events or hepatotoxicity).

  13. Kang JG, Park CY. Anti-Obesity Drugs: A Review about Their Effects and Safety. Diabetes Metab J 2012; 36: 13-25. PubMed Citation.  (Review of the safety and efficacy of current and potentially future medications for obesity; mentions that no serious adverse events have been reported in controlled trials of diethylpropion).

 

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OTHER REFERENCE LINKS
Diethylpropion

 

  1. PubMed logoRecent References on Diethylpropion

  2. Clinical Trials logoTrials on Diethylpropion

  3. TOXLINE logoTOXLINE Citations on Diethylpropion

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