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Diet Drugs

Definition

Diet drugs are medications that may help obese people lose weight when the drugs are used together with a program of diet and exercise. Historically, many drugs have been used as weight loss aids, and some ineffective products have been marketed with claims of helping in a program of weight loss.

Purpose

All diet drugs are intended to reduce caloric intake or increase calorie usage, however the methods vary.

Description

Appetite suppressants (anorexiants).

Most FDA-approved weight loss drugs suppress appetite by affecting one or more neurotransmitters in the brain. These are hormones control appetite and mood. The model for these drugs is amphetamine, although there are many closely related drugs including the botanical product epehdrine. The mechanism of action of amphetamines on appetite suppression is not fully understood. It is known that amphetamines and amphetiamine-like drugs cause the release of nor-epinephrine and dopamine. Although they are stimulants, amphetamines do not increase the basal metabolic rate, the rate at which the body uses energy while in a resting state. Phenylpropanolamine had been approvel by the United States Food & Drug Administration as an over-the-counter aid to diet in 1983, but this approval was withdrawn after several reports of hemorrhagic stroke associated with use of the drug.

Most weight loss drugs are approved for only a few weeks, and weight rapidly returns once the drug is discontinued. Long-term studies do indicate that continued use of weight loss drugs may be effective in maintaining weight loss, but in most cases long-term studies have not been conducted to adequately demonstrate safety. This was a particular problem with amphetamine and its derivatives, which are classified as controlled substances. Sibutramine, sold under the brand name Meridia, was approved by the FDA in 1997 for use up to two years. Safety and efficacy beyond two years has not been established. Sibutramine reduces appetite by inhibiting the reuptake of norepinephrine, dopamine, and serotonin. One study found that patients taking sibutramine lost an average of 7–10 lb (3–5 kg) more over one year than those on a low-calorie diet alone.

High fiber foods have also been advocated as appetite syppressants. A typical example is gluco-mannan, a dietary fiber derived from the root of the elephant yam or konjac plant, which is native to Asia. The theory behind use of foods that contain non-digestable fiber had been that these foods caused abdominal distention, swelling of the stomach, which was believed to cause a feeling of fullness, without increasing calorie intake. Studies and reviews of the effects of glucomannan and other non-nutritive fiber products such as bran have had varying results, but several of these studies have been encouraging. One Norwegian study compared three different kinds of fiber along with a highly calorie restricted diet and reported “Glucomannan induced body weight reduction in healthy overweight subjects, whereas the addition of guar gum and alginate did not seem to cause additional loss of weight.” A British study reviewed the effects of guar gum, a fiber which is often used as a thickening agent in food products, for its value in weight reduction. The researchers concluded that guar gum was not effective in aiding weight loss and the risks associated with taking guar gum outweight its benefits. It appears that fiber, or the stomach expansion which fiber causes, is not adequate to reduce calorie intake. If there is a special benefit to glucomannan as indicated by the positive studies, its mechanism of action has not been explained.

Past evidence indicated that elevated blood glucose reduced appetite. This belief was the basis for the claim that sweets before meals would ruin an appetite.

Diet pills approved by the U.S. Food and Drug Administration

Generic nameTrade name(s)Drug typeFDA approval date
Approved for short-term use   
diethylpropionTenuate, Tenuate dospanappetite suppressant1959
phendimetrazineBontril, Plegine, Prelu-2, X-Trozine, Adipostappetite suppressant1982
phentermineAdipex-P, Fastin, Ionamin, Oby-trim, Pro-Fast, Zantrylappetite suppressant1959
Approved for long-term use   
orlistatXenicallipase inhibitor1999
sibutramineMeridiaappetite suppressant1997

SOURCE: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, U.S. Department of Health and Human Services.

Most currently available weight-loss medications are FDA-approved for short-term use, meaning a few weeks, but doctors may prescribe them for longer periods of time. Sibutramine and orlistat are the only weight-loss medications approved for longer-term use in patients who are significantly obese. Their safety and effectiveness have not been established for use beyond two years. (Illustration by GGS Information Services/Thomson Gale.)

High glucose diet aids were marketed based on this concept. One example was the Ayds diet candy, which contained more sugar than regular candy, and was widely marketed in the 1970s. These products were found to be ineffective as an adjunct to diet and exercise in a weight loss regimen. While Ayds was reformulated to contain phenylpropanolamine, the similarity of the name to the disease AIDS eventually drove this product off the market.

Topical anesthetics

In 1983, the Food & Drug Administration approved the use of benzocaine, a topical anesthetic widely used in first aid sprays, as an aid to weight-loss programs. The claim was that benzocaine, in the form of lozenges or gums, would anesthetize the tongue, making food less attractive. More recent studies have failed to show any significant benefit to benzocaine as a weight loss.

Lipase inhibitors

In 1999 the FDA approved orlistat—the first of a new class of anti-obesity drugs called lipase inhibitors—for long-term use. Orlistat, marketed under the brand name Xenical inhibits the pancreatic enzyme lipase that breaks down dietary fat. This decreases the body’s absorption of dietary fat by as much as 30%. The undigested fat is excreted in the stool.

Orlistat is prescribed for overweight or obese patients who also have:

  • high cholesterol
  • diabetes
  • high blood pressure
  • heart disease

On February 7, 2007, the FDA approved orlistat for non-prescription sale.

Other agents

A large number of other agents have been offered for over-the-counter sale as weight loss agents, however they have not been either adequately studied or properly standardized, and so can not be recommended. One typical example is chitosan a fiberous material made of shellfish shells. This material may adsorb fats, preventing their digestion, and thereby reducing caloric intake. Several studies have reported favorably on the effects of chitosan, but a careful analysis of these studies indicates that in the best conducted studies, the overall weight reduction benefits are trivial, and preparations containing chitosan cannot be recommended.

Many of the products marketed as herbal have been found to be adulterated with active drugs, including sibutramine and amphetamine. People taking these agents under the impression that they are safe because they are labeled as natural products may be taking inappropriate doses of active drugs. One Chinese remedy was found to contain Aristolochic acid which was found to be responsible for six deaths due to kidney failure among patients at a Belgian health spa.

Another reviewer examined studies relating to complimentary and alternative treatments for obesity. None of the drugs reviewed appeared to show convincing evidence of value based on published studies, although hyponotherapy did appear to be of potential value in weight reduction. While the overwhelming majority of complimentary and alternative medicines marketed for weight reduction are harmless, the lack.

KEY TERMS

Anorexiant—A drug that causes loss of appetite.

Caloric—Relating to heat or calories, also, full of calories, and so likely to be fattening.

Dopamine—A neurotransmitter and precursor of norepinephrine; found in high concentrations in the brain.

Fiber—Nutrients in the diet which are not digested by enzymes. Insoluable fiber travels through the digestive tract and has a laxative effect.

Glucomannan—A plant substance composed of long chains of the sugars glucose and mannose. It is not digested, and may be ised as a laxative. The material has been claimed to provide a feeling of abdominal and intestinal fullness.

Hemorrhagic—Relating to escape of blood from the vessels. Bleeding.

Homeopathic—Relating to homeopathy, a system of treating diseases by giving people very small doses of natural substances which, in healthy people, cause the same symptoms as the disease being treated.

Norepinephrine—A hormone that constricts blood vessels.

Stroke—The sudden death of brain cells when the blood supply is disrupted either through blockage or bleeding.

Thermogenic—Producing heat. Relating to diet drugs the term is used to indicate a drug which causes increased use of calories without exercise.

of evidence of efficacy makes their use inadvisable since there is no reason to accept any risk.

Some products claim to increase the body’s ther-mogenesis. According to these claims, the body will burn more calories in the resting state, leading to increased weight loss. At one time, thyroid hormone was prescribed for this purpose, but because of the very high risks associated with thyroid, this use has been discontinued. Comparable claims have been made for green tea extract, but the weight loss benefits of these products are not clear. In one study, patients taking green tea had greater weight loss than the subjects in the control group, but on careful review, it was found that patients in the active group were exercising more than patients taking placebo.

Homeopathic remedies have been offered as weight loss products. Homeopathy itself is controversial at best, and there have been no reputable studies indicating that homeopathic remedies have any value in weight reduction.

Starch blockers are products which inhibit the digestion of starch, and so reduce its caloric value. This, in theory, should lead to reduced effective calorie intake, however the value of these products has not been demonstrated. Because these products are made from bean husks, there has been an ongoing dispute in the courts. The manufacturers argue that their products are animal feed, and not subject to regulation as drugs, while the FDA has argued that the intended use of the starch blockers is as a drug, and should be subject to regulation. The courts have been divided on how these products should be defined.

Precautions

Because of the lack of standardization and high frequency of adulteration in some products marketed as herbal or natural weight loss remedies, people choosing to buy products of this type should deal only with a known and reputable supplier.

No weight loss product has demonstrated the ability to induce weight loss without diet, exercise, and behavioral modification. Although orlistat has been approved for long-term use, this is defined as up to two years, and in controlled studies, patients taking the drug showed increases in weight during the second year.

Aftercare

Weight-loss drugs are used as short-term adjuncts to programs of diet, exercise, and behavioral changes, such as portion control, that are intended to maintain lifetime weight goals. These behaviors must be continued after the drugs are discontinued.

Parental concerns

Weight-loss drugs are not normally indicated for children under the age of 16. Children should not use these drugs without proper medical supervision.

BOOKS

Reynolds, J E ed. The Extra Pharmacopoeia, 30th edition. London: The Pharmaceutical Press.

PERIODICALS

Birketvedt, GS, M. Shimshi, T. Erling, and J. Florholmen. “Experiences with three different fiber supplements in weight reduction.” Medical Science Monitor. 11 (January 2005)PI5–8.

Brody, j. “Personal health: pills to aid the dieter: how safe are they?” The New York Times, November 9, 1983.

Gillerot, G, M. Jadoul, VM Arlt, et. al. “Aristolochic acid nephropathy in a Chinese patient: time to abandon the term “Chinese herbs nephropathy”?” American Journal of Kidney Disease (November 2001): E26.

Greenway, F, D. Herber, W. Raum, D Herber, and S. Morales. “Double-blind, randomized, placebo-controlled clinical trials with non-prescription medications for the treatment of obesity.” Obesitye Research (July 1999): 370–8.

Jung J, M. Hermanns-Clausen, and W. Weinmann. “Anorectic sibutramine detected in a Chinese herbal drug for weight loss.” Forensic Sci Int. (September 2006): 221–225.

Keithley, J and B. Swanson. “Glucomannan and obesity: a critical review.” Alternative Therapeutic Health Medicine (Nov-Dec 2005): 30–4.

Ni Mhurchu, C, CA Dunshea-Mooij, D. Bennett, and A. Rodgers. “Chitosan for overweight or obesity.” Cochrane Database Syst Rev (July 2005):CD003892.

Opala, T, P. Rzymski, I. Pischel, et al. “Efficacy of 12 weeks supplementation of a botanical extract-based weight loss formula on body weight, body composition and blood chemistry in healthy, overweight subjects–a randomised double-blind placebo-controlled clinical trial.” European Journal of Medical Research 11 (August 2006): 343.

Pittler, MH and E. Ernst. “Complementary therapies for reducing body weight: a systematic review.” International Journal on Obesity (Lond) (September 2005): 1030–8.

Pittler, MH and E. Ernst. “Guar gum for body weight reduction: meta-analysis of randomized trials.” American Journal of Medicine. 15(June 2001): 724–30.

ORGANIZATIONS

American Obesity Association. 1250 24th Street, NW, Suite 300, Washington, DC 20037. 800-98-OBESE (800-986-2373). <http://www.obesity.org>

Food and Drug Administration. U.S. Department of Health and Human Services, Public Health Service, 5600 Fishers Lane, Rockville, MD 20857. <http://www.fda.gov>

Weight-control Information Network (WIN). National Institute of Diabetes and Digestive and Kidney Diseases. 1 Win Way, Bethesda, MD 20892-3665. 877-946-4627. 202-828-1025. <http://www.niddk.nih.gov/health/nutrit/win.htm>

Samuel D. Uretsky, PharmD


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