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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.
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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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