Myrlene Staten, M.D., Senior Director of Lederle Laboratories, writes:
"Ideal charcteristics of an antiobesity drug are as follows:
Sadly, even in the age of medical wonders and advancements in technology, no drug exists that fits all these characteristics.
In late 1989, the American Society of Bariatric Physicians appointed a task force to study medications used to decrease appetite and increase metabolism in humans (called "anorectic" medications). The goal of the task force was to establish guidelines for their safe usage. After one year of study, which involved literature review, a polling of the ASBP membership, and input from university-based investigators, a consensus was reached regarding the guidelines. Basically, the guidelines state that it is rational to consider these drugs as part of a complete obesity treatment program after a thorough initial patient evaluation and when the patient is medically-supervised at regular intervals. In addition, for patients who need them, these anorectics may be reasonably and safely used for far in excess of the FDA-approved guidelines of a "few months" and, in some cases, in doses exceeding those suggested in the FDA-approved labeling. The complete and updated guidelines for the use of appetite suppressant (anorectic) medications for the purposes of weight loss can be found at the ASBP web site at this link.
Usage of medications outside the governmental guidelines, which are usually the most conservative recommendations for all drugs, is often done by physicians at their own discretion. This is referred to as "off-label" use. For example, bupropion (Welbutrin™) is FDA approved for the treatment of depression. It is used by psychiatrists and other physicians for smoking cessation, obesity, anxiety, and other uses. Metformin is a drug developed many years ago for the treatment of Type 2 (Adult-Onset) diabetes. It is being used by doctors worldwide for weight loss and other complaints. These are examples of off-label use.
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What is “off-label” use? Although the FDA regulates how a medication can be advertised or promoted by the manufacturer, these regulations do not restrict a doctor’s ability to prescribe the medication for different conditions, in different doses, or for different lengths of time. The practice of prescribing medication for periods of time or for conditions not FDA-approved is known as “off-label” use. While such use often occurs in the treatment of many conditions, you should feel comfortable about asking your doctor if he or she is using a medication or combination of medications in a manner that is not approved by the FDA. The use of more than one weight-loss medication at a time (combined drug treatment) is an example of an off-label use. Using weight-loss medications other than sibutramine or orlistat for more than a short period of time (i.e., more than “a few weeks”) is also considered off-label use. |
Continuing long-term usage should be conditional on the patient achieving a "significant clinical responses." That means, continued usage of the medications depends on the patient losing one pound per week and/or achieving and maintaining a weight loss of at least 10% of the initial weight. Blackburn and Kanders, writing in the American Journal of Cardiology, cited a number of clinical studies and concluded that a 10-15% decrease in body weight is clinically significant. Paramount in any long-term treatment is the physician's responsibility for tailoring the therapy to the individual patient.
There are three general classes of medications currently approved by the FDA for treating obesity. They are:
| Drug Name |
Class |
Year Approved |
Comments |
| sibutramine (Meridia) |
appetite suppressant |
1997 |
- One study of 2 years duration - Once daily administration |
| orlistat (Xenical) |
fat blocker |
1999 |
- High incidence of GI side effects |
| phentermine (Adipex, Ionamine) |
appetite suppressant |
1959 |
- No studies beyond 9 months |
Phentermine is the oldest of the group and the drug with which we have the longest experience. It has few side effects in properly screened patients. The most frequent side effects I see in my practice are dry mouth and constipation. It can, in the first few days of use, cause insomnia, nervousness and, very rarely, palpitations and anxiety. These side effects are, in my experience, very short-lived and resolve within a few days of continued use. If you experience any significant side effects from the medications prescribed in the ABC, please notify the staff immediately. We will guide you directly and individually in the best way to alleviate and minimize them.
Other drugs used for weight management include:
| GENERIC NAME | TRADE NAME(S) |
| Diethylpropion |
Tenuate, Tenuate dospan |
| Mazindol |
Sanorex, Mazanor |
| Phendimetrazine |
Bontril |
Common Questions and Answers about Using Medications for Obesity Treatment:
:
Can medications
replace physical activity or changes in eating habits as a way to lose weight?
No. Studies
show that weight-loss medications work best when combined with a weight-control
program that helps you improve your eating and physical activity habits. Ask
your doctor about ways you can improve your eating plan and become more physically
active.
What medical
conditions or medications might influence my decision to take a weight-loss
drug?
Let your
doctor know if you have any of the following medical conditions, which may
affect which weight-loss drugs you can take, if any:
How long
will I need to take weight-loss medications to treat obesity?
The answer
depends upon whether the medication helps you to lose and maintain weight
and whether you have any side effects. Because obesity is a chronic disease,
any treatment, whether drug or non-drug, may need to be continued for years,
and perhaps a lifetime, to improve health and maintain a healthy weight. However,
like many other types of drugs, there is still little information on how safe
and effective weight-loss medications are for many years of use. At least
one study has shown that intermittent use (one month on medication and one
month off medication) may help some people lose and maintain weight, but more
research is needed.
Will I regain
some weight after I stop taking weight-loss medications?
Probably.
Most studies show that the majority of patients who stop taking weight-loss
medications regain the weight they lost. Maintaining healthy eating and physical
activity habits may help you regain less weight.
Can children
or teens use weight-loss medications?
Orlistat
is currently approved for use in teens age 12 or above. Other weight-loss
medications are not approved for use in children under the age of 16, although
studies in children and teens are ongoing.
Will insurance
cover the cost of weight-loss medication?
Many insurance
companies currently will not pay for weight-loss prescriptions, but this is
changing as insurers begin to recognize obesity as a chronic disease. Contact
your insurance company to find out if prescription weight-loss medication
is covered under your plan. The cost of one month of a prescription can cost
about 60 dollars a month to more than twice this amount. Ask a staff member
at your pharmacy the cost of a 1-month supply of the medication you are considering
taking.
Most patients should not expect to reach an “ideal” body weight using currently available medications. However, even a modest weight loss of 5 to 10 percent of your starting body weight can improve your health.
Together, you and your doctor can make an informed choice as to whether medication can be a useful part of your weight-control program.
Unfortunately, and in an apparent discriminatory manner, most employers commonly exclude prescription drugs for the treatment of obesity from their coverage plans. According to one 2003 survey, 72% of employers excluded coverage of this class of medication class while 19% provided limited coverage. Only 9% provided standard (full) coverage of the medications. The trend in coverage has remained relatively constant for the years 2000, 2001 and 2002 at 69%, 70% and 72%, respectively. In the chart below, you can see that employers were more likely to provide coverage for smoking cessation, infertility, and birth control than they were for the treatment of obesity.
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Common Drug Exclusions |
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|
OTC |
Weight Loss |
Smoking Cessation |
Fertility |
Steroids |
Oral Contraceptives |
|
95% |
72% |
57% |
51% |
44% |
11% |