DRUGS APPROVED BY THE FDA FOR WEIGHT LOSS

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Март 12, 2009

DRUGS APPROVED BY THE FDA FOR LOSS

Drugs approved for use in loss programs can be broken
down into the following categories:

1. Anorexiants (drugs that work on chemicals in the brain)
 a. Amphetamines
1. Benzphetamine (Didrex®)
2. Diethylpriopion (Tenuate®; Tenuate Dospan®)
3. Methamphetamine (Desoxyn®)
4. (Adipex®; Adipex®-P or Ionamin®)
b. Sibutramine ()
2. Lipase Inhibitors (drugs that prevent from being absorbed into the bloodstream)
a. Orlistat®

Drugs that work in the brain are considered appetite suppressants. Amphetamines are approved for use in treating other diseases; their use as a loss drug is considered “off label,” or not approved. Doctors often prescribe drugs for “off-label” use, meaning that the drug is used at a different dose, for a longer time, or for a different medical condition than was approved by the FDA. Off-label prescribing is a common, and legal, practice.

Amphetamines, which have appetite-suppressing effects, are approved by the FDA for loss, but only for shortterm use (12 weeks or less). Only a handful of studies have evaluated their use for periods longer than six months. Scientists do not fully understand how amphetamines and like drugs work. It is believed that these drugs cause the release of norepinephrine and dopamine, two chemical messengers that control hunger, in the brain. In addition, it is thought that amphetamines decrease the sharpness of a person’s senses of smell and taste, which ultimately results in appetite-suppressing properties.

Another benefit of amphetamines is that they allow someone who is or overweight the opportunity and time to learn proper loss techniques, such as and exercise. Because they are addictive, amphetamines are not often recommended for use in loss. Amphetamines and like drugs only bring about a very small amount of loss (3–8% decrease in when compared to placebo). So, since amphetamines are addictive and not very effective for long-term control, they are not recommended for loss.

Amphetamines and like drugs only bring about a very small amount of loss. The usual loss that occurs is only 5 to 10 pounds. Often, the loss effects only last for a few weeks.The way these drugs help induce loss is by providing the patient the time and opportunity he or she needs to learn proper loss techniques.

BENZPHETAMINE (DIDREX®) AND METHAMPHETAMINE (DESOXYN®)

DIDREX

DIDREX

Benzphetamine and methamphetamine are similar to Pills and the FDA 57 both structurally and functionally. They work by stimulating nerves in the brain, which increases heart rate and blood pressure while decreasing appetite. Benzphetamine is prescribed to be taken once a day 30 to 60 minutes before breakfast.Methamphetamine is given in 5-mg doses 30 minutes before each meal. It is important not to increase the dose or take the drug more often then the says. Usually, these drugs are taken for 8 to 12 weeks. An illegal form of methamphetamine called “crank” is made in underground laboratories from over-the-counter drugs such as Sudafed® and sold as a drug of Often, “crank” contains many other illegal compounds that work to produce psychological effects.

People who are and who have diabetes, often find they initially cannot control their blood sugar well. Therefore,
these patients must increase the number of times each day they monitor their blood sugar. Benzphetamine, out of the entire class, causes less stimulant activity; this quality could make it more attractive to doctors. But tolerance
(the body’s ability to resist the effects of the drug) can develop quickly and adequate loss has not been observed beyond six months.

DIETHYLPROPION (TENUATE®; TENUATE DOSPAN®)

Tenuate

Tenuate

Diethylpropion is also similar to in both structure and function. This drug is available in an immediaterelease form (which must be taken more often during the day) and as a controlled-release preparation that is only taken once a day.

The dose of this drug is usually 25 mg taken three times a day before meals; the controlled-release product is taken 75 mg mid-morning. The last dose of diethylpropion should be taken four to six hours before bedtime. Studies have shown that people taking diethylpropion achieve a loss of 17.4 to 19.1 pounds at six to 12 months. This is in comparison to people who took a sugar pill and lost no

(ADIPEX®; ADIPEX®-P OR IONAMIN®)

PHENTERMINE (ADIPEX®; ADIPEX®-P OR IONAMIN®)

(ADIPEX®; ADIPEX®-P OR IONAMIN®)

is similar to both structurally and functionally, but has less potential for It is available in both an immediate-release and sustainedrelease form. The dose is 30 mg once a day in the morning.

Some doctors prescribe smaller doses to be taken with every meal. has been found to be effective for loss, but only when used along with exercise, and other behaviors, such as simply setting up a goal or rewarding loss. Researchers have found that people may not need for long periods of time, but only from time to time. Some people who take end up regaining that they lost, even while still taking the drug, and often stop using it because they feel it is not working.

OF AMPHETAMINES

The largest drawback to the use of amphetamines is the often severe that can occur. All amphetamines can cause nervousness, dry mouth, insomnia, anxiety, elevated heart rate, high blood pressure, and heart palpitations. Another side effect of amphetamines is artificially elevated feelings of selfconfidence. Abusers of amphetamines have a false sense of well-being; they feel like they are invincible and could “conquer the world.”

Another major drawback of amphetamines and like drugs is that because their appetite-suppressive effects do not last long, their loss effects wear off after a short time. This is why physicians prescribe some of them to be used for only a few days at a time, then put the patient on a “drug holiday” for the next few days. This routine allows for the effective use of these drugs over a longer period of time. There are only a few agents approved for use in treating obesity. The fact that these agents are not prescribed frequently reflects the point that they can be potentially dangerous to use.

SIDE EFFECTS OF AMPHETAMINES

OF AMPHETAMINES

Shown here is a picture of phenteramine pills. If this medication, or any of the others discussed in this chapter, is purchased from an illegal Website without a prescription, the pills might not look like this. Pills purchased from Website without a prescription may not contain phenteramine and only contain sugaror, worse, may be laced with other illegal, more potent drugs.

In addition to all of the they can cause, another problem with amphetamines is that people can rapidly develop an addiction to them. The addiction starts because these agents are like speed, an illegal drug that “revs up” the body. It also has the ability to induce a feeling of euphoria, which is what makes the drug so appealing and addictive. Speed makes the heart beat faster, which has the effect of keeping the body moving even when it is extremely fatigued.

Amphetamines offer the appealing benefit of allowing a person to sleep less Figure 5.2 Shown here is a picture of phenteramine pills. If this medication, or any of the others discussed in this chapter, is purchased from an illegal Website without a prescription, the pills might not look like this. Pills purchased from Website without a prescription may not contain phenteramine and only contain sugar or, worse, may be laced with other illegal, more potent drugs. and accomplish more. However, addiction does produce problems in the body. Signs of addiction include:

schizophrenia (a mental disorder)—this is the most
serious sign of addiction

When a person who is addicted to amphetamines suddenly
stops taking the drug, he or she usually experiences unpleasant
withdrawal symptoms, including:

When a person taking amphetamines stops taking them, his or her body may need to adjust. How long these withdrawal symptoms last depends on how long and how often the drug was taken. Often, a person will experience feelings of being extremely tired, weak, and easily confused—these feelings go away in time.

SIBUTRAMINE ()

SIBUTRAMINE (MERIDIA®)

SIBUTRAMINE ()

Sibutramine is approved by the FDA for long-term management of loss; it can be used for approximately one year. Pills and the FDA Sibutramine is a noradrenergic and serotonergic agent, which means that it works by suppressing the neurotransmitters in the brain that control appetite, and by increasing the rate at which food is broken down. Studies have shown that patients taking sibutramine achieve an average loss of 17.6 pounds (8 kg) to 19.8 pounds (9 kg), although some patients have been able to lose more.

The starting dose of sibutramine is usually 10 to 15 mg once a day. The drawback of this drug is that, as with all medications used to treat obesity, the lost eventually reappears unless the patient continues to engage in healthy eating habits and an exercise program.

One study of people who used sibutramine for two years (although the FDA only approved one year of use) showed one possibly positive effect of this drug: continued maintenance. In this study, over 80% of people who took sibutramine for two years kept their constant. Along with the maintained loss, researchers also found that patients were able to decrease the lipid ( in their bloodstream, which has beneficial effects on the of the heart.

Sibutramine use also carries the risk of which include elevated blood pressure, increased heart rate, dry mouth, nausea, and dizziness. of sibutramine can cause dilated pupils, excessive bleeding or bruising, tremor, and anxiety. As with all prescription drugs, it is essential to use sibutramine according a s instructions. The alternative is the possibility of unpleasant and dangerous outcomes.

ORLISTAT ()

ORLISTAT (XENICAL®)

ORLISTAT ()

The last class of loss drugs approved by the FDA is lipase inhibitors. Drugs in this category prevent the body from absorbing into the bloodstream, which creates conditions that make it easier for loss to occur. Clinical studies have shown that lipase inhibitors produce a dose-dependent decrease of (meaning that at low doses, a person sees less loss than would be seen at higher doses). Most patients who take these drugs achieve a loss of 6.6 pounds (3 kg) to 8.8 pounds (4 kg). The usual dose of these drugs is 1three times a day. Patients must be sure to take a multivitamin each day—it has been found that in addition to decreasing the amount of ingested with each meal, lipase inhibitors also block the absorption of essential vitamins in food.

One study undertaken to assess lipase inhibitors in overweight, diabetic patients concluded that these patients not only achieved significant loss but were also better able to control their blood sugar. Other studies have shown that patients who were at high risk for developing diabetes did not do so when taking orlistat; in these patients, excess was the cause of developing diabetes.

The of orlistat are extremely unpleasant. Patients may experience abdominal pain, gas, and discomfort when taking this drug; the abdominal problems that occur are even more intense after the patient eats a high-meal. Since orlistat is a lipase inhibitor, it prevents from being absorbed by the body. Thus, the in food comes out of the body in the stool, causing these

Often, these effects make people stop taking lipase inhibitors almost as soon as they start it. Most patients are unwilling or unable to endure the Patients soon realize that these effects become less intense when they change their and eat foods that are lower in There is not a significant potential with lipase inhibitors. If occurs, the patient experiences even more severe forms of the drug’s already unpleasant and thus people often avoid taking the drug if it is not necessary,
or avoid taking more of it than prescribed.

FRANK
Frank is 44 years old, 5 feet 8 inches tall, and weighs 190 lbs. His BMI is 27 and, thus, he is considered overweight.
Frank is taking a prescription to help manage his diabetes. He also has high blood pressure. His has told him that he must lower his to get his diabetes and high blood pressure under control.
He has tried on his own to He started going to Watchers™ and is walking more. In spite of this, he is not losing any His told him about a prescription medication called , which may help him does not interact with any of the medications he is taking right now.
Frank decided that he would try taking this Although plagued with multiple that affected mainly his bowels, he lost He knew that if he ate fewer fatty foods, the digestive would lessen. He did this and stuck with the medication. He has lost 15 pounds and would like to lose more. Frank has already seen a change in his blood pressure, and his diabetes medicinedosage is lower.

Frank is motivated and wants to He has lost
and does not want to look back on the days when he
was overweight. He wants to continue to lose and maintain
his loss, not only for cosmetic reasons, but because
he realizes the negative effects of being overweight.

GUIDELINES FOR USE OF CONTROL DRUGS

The National Institutes of (NIH) has developed a list of guidelines that should be used when a patient is prescribed a loss drug. If a patient does not meet all criteria for drug therapy, then and exercise should be used instead.loss drugs come with many and contraindications (reasons why the drug should not be used), and they can be addicting and lethal. The NIH guidelines recommend that:

  1. All individuals begin with modification and exercise.
  2. If changes do not bring about loss (10% of initial or 1 pound (0.5 kg) per week), drug therapy may be started.
  3. If the patient does not lose 4.4 pounds (2 kg) in the first four weeks of drug treatment, drug therapy might have to be changed or the dose increased when possible.

There is an increasing interest in loss drugs among doctors and consumers. Because of adverse effects that may occur, it is important for doctors and patients to proceed with drug therapy very cautiously. Drug therapy for overweight and obesity is only based on a small number of clinical trials.loss drugs should only be used as part of a program that includes and physical activity. The patient must be taught to set goals that he or she can achieve and give him- or herself rewards for loss.
Obviously, once a loss drug is no longer being taken, and exercise are the only ways that can be lost. The manufacturers of drugs to treat obesity must continue to work toward developing safer and more effective products.


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