Drug therapy is commonly recommended as a treatment option for obese individuals as a supplement to their weight loss program.
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Medications - Issues and Options

The most important thing a person can do to combat obesity is to prevent obesity before it develops. For those who need to treat or manage obesity, there are numerous options to consider. Weight loss and weight management efforts to combat obesity require a balanced combination of behavioral change and medical intervention. Although consuming fewer calories and implementing a regular exercise regimen are essential to the weight-loss process, some individuals dealing with obesity may need to incorporate prescription drug therapy into their weight loss program. Drug therapy is commonly recommended as a weight loss treatment option for persons with either a BMI or Body Mass Index > 30 who have no obesity-related conditions, or a BMI - Body Mass Index > 27 with two or more obesity-related conditions40.

U.S. Food and Drug Administration (FDA)-Approved Medications
Medication for treating obesity, as prescribed and monitored by a physician, may be beneficial for some obese patients and their weight-loss regimen when combined with lifestyle, behavioral and dietary modifications. There are currently two drug types that are approved by the FDA for the long-term treatment of obesity.

Long-term Obesity Treatments41
Sympathomimetic Drugs – These weight loss drugs help treat obesity by suppressing one’s appetite through restricting nerve endings’ ability to pick up norepinephrine and serotonin42. Sibutramine, the generic marketed as Meridia® in the U.S. and Reductil® abroad, is manufactured by Abbott Laboratories.

Lipase Inhibitors – This class of weight loss drugs prevents the action of lipases – the enzymes that break down fat – produced in the pancreas43. Orlistat, the generic marketed as Xenical®, which is manufactured by Roche Pharmaceuticals, is the only weight loss drug approved to alter the way the body responds to fat intake. In February 2004, the FDA approved Xenical’s use for the treatment of obesity among adolescents, thereby making Xenical the first approved weight-loss treatment for children and adolescents in the U.S.

Short-term Obesity Treatments
Other FDA-approved weight loss prescription formulations include Bontril® (phendimetrazine tatrate), manufactured by Carnrick Pharmaceuticals; Tenuate® (diethylpropion), manufactured by Aventis Pharmaceuticals; Didrex® (benzphetamine), manufactured by Pharmacia Corporation/Pfizer; and Lonamin®, Oby-Cap®, Fastin® and Adipex-P® (phentermine), manufactured by several pharmaceutical companies. People treating obesity that have chronic conditions including heart disease, high blood pressure (including hypertension) or thyroid problems (thyroid disease, hypothyroid) should not use these weight loss drugs44.

Future Treatments
Clinical trials for several weight loss drugs that are not yet approved for the treatment of obesity are currently being conducted. For instance, Metformin® was recently found to produce a one to three kg. weight loss over an average of 2.8 years in the randomized, double blind Diabetes Prevention Program (DPP)45. Bupropion, which is marketed as Amfebutamone®, Wellbutrin® and Zyban®, is an anti-depressant and anti-smoking drug that produced significantly more weight loss in a randomized clinical trial than placebo during a one year examination46. Although it was found effective for significant weight loss, Topiramate®, a drug approved for treatment of epilepsy, also produced significant side effects during several trials of six to 12 months duration47. Zonisamide®, an anti-epileptic drug, also produced significant weight loss in a four-month randomized clinical trial48. Most recently, rimonabant administered to patients with dyslipidemia produced significant weight loss in patients, while decreasing triglyceride and increasing HDL-cholesterol levels and reducing blood pressure. The trial, which spanned one year, also demonstrated rimonabant’s potential as an effective treatment to aid in smoking cessation49. This drug has not yet been FDA-approved for any indications.

Over-the Counter (OTC) Weight Loss Treatments
Many OTC weight loss pills contain ephedrine, a compound that encourages weight loss by reducing the patient’s appetite while stimulating the body to produce more heat. One form of this weight loss drug is found in the Chinese plant ma huang and is sold in the U.S. without a doctor’s prescription. There are many other herbal weight loss treatments containing ephedrine marketed to promote weight loss. Ephedrine is not proven safe for the treatment of obesity. Although some preliminary studies had shown that taking supplements containing ephedrine was, at times, associated with weight loss, it is important to note that there are serious side effects associated with this weight loss treatment50. On February 6, 2004, the FDA published a regulation prohibiting the sale of weight loss supplements containing ephedrine. This prohibition took affect April 12, 200451. The Endocrine Society supports this regulation. Individuals are strongly advised to consult with a physician before taking any OTC product for weight loss.

Other OTC weight loss pills, including Dexatrim® and Acutrim®, are now ephedrine free. Although these products could be used in the treatment of obesity and claim to help weight loss by boosting energy levels and stimulating metabolism, there are no published peer-reviewed data to support these weight loss claims.

The Endocrine Society and The Hormone Foundation Address Herbal Remedies and Dietary Weight Loss Supplements for the Treatment of Obesity

Herbal medicines and dietary supplements for weight loss and treating obesity are growing in popularity and acceptance in the U.S. However, few of these weight loss products have been subjected to the type of rigorous research and clinical testing that conventional medicines for treating obesity undergo. Moreover, dietary supplements are not bound by the same regulatory standards as prescription and over-the-counter (OTC) weight loss products.

Products containing ephedrine are among these OTC weight loss medicines. The potential risks of ephedrine in weight loss products have been recognized by the FDA and the scientific community and have led to significant regulation in dosing and manufacturing practices. The Endocrine Society and The Hormone Foundation support the FDA’s proposed rule regarding warning statements for dietary weight loss supplements containing ephedrine alkaloids.

This proposed warning label provides consumers with a fair assessment of the risks associated with the use of ephedrine alkaloids for weight loss based on scientific data. The Society and the Foundation also support the FDA’s efforts to contact ephedra manufactures to notify them that they are in violation of the Federal Food, Drug, and Cosmetic Act by making unsubstantiated weight loss claims on the benefits of ephedra use. Based on the current scientific data, claims of long-term weight loss and increased athletic ability cannot be supported. The Society and the Foundation believe that this scientific evidence is sufficient for new restrictions on products regulated under the Dietary Supplement Health and Education Act (DSHEA).

Further, the Society and the Foundation encourage the U.S. Department of Health and Human Services to support increased research efforts and grant allotments on the effects/benefits of dietary supplements that may prove as treatments for obesity.

Ephedra and other types of weight loss supplements should be used with caution and only after consultation with a healthcare provider.

Herbal medicines and dietary supplements can interact with prescription and OTC medicines. Certain herbals and weight loss supplements may also have side effects that contribute to, or complicate, existing health or obesity-related conditions, such as high blood pressure (hypertension). It is extremely important that patients discuss with their healthcare provider any herbals and weight loss supplements they consume.

Additional research into the impact and effect of herbal medicines and weight loss supplements is required.

NOTE: As of press time, the nationwide FDA ban on supplements containing ephedrine was enacted. Components of this regulation may be amended at a later date.

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