FDA-approved prescription weight-loss medications

Obesity is a chronic disease! In order to lose and maintain that weight, it is necessary to modify one’s diet and engage in regular physical activity. Some people, though, may require additional treatment. This is where prescription weight loss drugs come in.

“Prescription weight-loss medications should be used only by patients who are at increased medical risk because of their weight. They should not be used for cosmetic weight loss. In addition, patients should have previously tried to lose weight through diet and physical activity.”

Prescription weight-loss drugs are approved only for those with:
~A body mass index (BMI) of 30 and above
~A BMI of 27 and above with an obesity-related condition

Most of the FDA-approved weight-loss medications are only supposed to be used for short-term use, meaning a few weeks.

Sibutramine and orlistat are the only weight-loss medications approved for long-term use in patients who are significantly obese. However, their safety and effectiveness have not been established for use beyond 2 years.

Appetite suppressants include sibutramine, phentermine, phendimetrazine, and diethylpropion. The promote weight loss by decreasing appetite and making you feel less hungry. They can also work by increasing the feeling of being full.

In the mid-1990s, doctors prescribed the appetite suppressant Redux ("phen-fen"). However, the drug was taken from the market in 1997 because it caused damage to heart valves!!!

Lipase inhibitors, such as orlistat, work by decreasing the body’s ability to absorb fat by about one-third. It blocks the enzyme lipase, the enzyme that breaks down dietary fat. When fat is not broken down, the body cannot absorb it, so it is eliminated and fewer calories are taken in.

The risks of prescription weight loss drugs - Talk to your doctor about concerns and risks of addiction, developed tolerance, and unpleasant side effects! Also keep in mind existing allergies you have, whether or not you are pregnant or breastfeeding, what other medications you’re taking, and if you have existing medical conditions.

Please click here for more information about FDA’s “New Prescription Drug Approvals” and “Prescription Drug Information.”

http://www.win.niddk.nih.gov/publications/prescription.htm
http://www.webmd.com/diet/guide/weight-loss-prescription-weight-loss-medicine
http://www.fda.gov/CDER/Drug/default.htm

When big was in...

Q: When did the idea that being thin was in and when was the "revolution" of weight suppressants?
A: The early 1960's and 1959 respectively - whether it was the change in individuals perception of themselves or it was the development of the first approved appetite suppressant, phentermine, weight has never been the same. There was a time when carrying extra weight was a sign of prosperity and that of being attractive. In fact, thirty years ago, the Chinese thought of "plumpness" as a sign of prosperity. Additionally, chubby babies were were thought to be symbols of good luck while those individuals who were thin had a difficult time finding someone to marry.

It wasn't much different here in the U.S. Females of the 1950's were curvy with larger busts and hips with the notion that "perfect" was for bust & hips to equal one another. WAIST and BUST were the focus of advertisements and not how much they weighed. Think Marilyn Monroe or Sandra Dee - definately curvy, busty and vivacious. It wasn't until the '60's that Sandra Dee became concerned with her "heaviness" and such, the desire to be thin starts. Who do you think is responsible? My opinion is everyone - from the media, government, consumers, drug companies, everyone! Yet there are few that will stand up to make a change. If we as a whole would take a vested interest and begin education early on of what is "healthy" versus what is "perceived expectations" then and only then might we make a difference.

http://web.mit.edu/lipoff/www/hapr/fall01_health/prosperity.pdf
http://home.att.net/~boomers.fifties.teenmag/1950_history.html

In the beginning...

Introduction of Appetite Suppressants

1959 Phentermine approved by FDA as first RX appetite suppressant
(to date, not withdrawn as there is no cause for heart valve disease)

1973 Fenfluramine approved by FDA as a RX appetite suppressant
(no longer marketed in the U.S. due to heart valve problems)

1990 Metabolife (ephedra)

1994 Congress passed DSHEA Law

1996 Dexfenfluramine (Redux) approved by FDA as a RX appetite suppressant
(no longer marketed in the U.S. due to heart valve problems)

September 1997 FDA withdraws fenfluramine and dexfenfluramine from the US market

2004 FDA bans the sale of dietary supplements containing ephedra

February 2007 FDA approves an OTC "weight loss aid" known as Orlistat

http://www.fda.gov/cder/news/feninfo.htm
http://www.medicinenet.com/
http://www.saveoursupplements.org/fight_for_policies.htmlhttp://en.wikipedia.org/wiki/Metabolife

Why should consumers and nurses be educated about weight loss pills??!

UNFORTUNATELY, despite what the ads say, there are no easy miracle weight loss pills. As Mom always reminds us, "If it sounds too good to be true, then it probably is!"

First, the FDA does not approve weight loss pills before the medications are sold. Also, the FDA can only take action against the drugs that are not safe or make false claims AFTER they've been put on the market.

Many weight loss pills have been recalled because of proven or potential harmful effects. One example is of phen-fen. The Mayo Clinic had first reported that fenfluramine and dexfenfluramine (sold as Redux) were linked to heart valve defects in women who had used the drugs, and the FDA ultimately withdrew the drugs after intense investigation.

In addition, the weight loss drug rimonabant was found to increase the risk for psychiatric disorders, including depression and anxiety. Clinical studies had found that rimonabant was a CB-1 receptor antagonist, which means that it blocked the CB-1 receptor. In turn, this blocked appetite and reduced food intake. Although rimonabant was effective for weight reduction, the FDA understandable did not want consumers developing psychiatric adverse effects and increased risk of suicide.

Another example is when the FDA warned consumers about the Brazilian diet pills. The pills contained active ingredients found in prescription drugs for anxiety, alcohol withdrawal, depression, OCD, panic disorder, and bulimia!!! A couple years later, the FDA warned consumers about 69 tainted weight loss pills that could cause serious and fatal health risks!

Anyone considering the option of weight loss pills should be on the lookout for red flags! Watch out for anything that promises a quick fix. Who runs the website? Is it really telling you about the pill or just trying to sell it? Is the information coming from reliable studies? Is the info up-to-date? If you're still not sure, CHECK IT OUT BEFORE PUTTING IT IN YOUR BODY OR ON YOUR SKIN!!! In fact, the FDA has developed Q&A's to help consumers, healthcare practitioners, and the general public understand the FDA's initiative against weight loss products. Click here to read it!

Remember! A good diet is based on adequate vitamins, minerals, protein, carbohydrates, fiber, a small amount of fat, and PLENTY of water. Several professional organizations (American Dietetic Association, American Heart Association, and Centers for Disease Control and Prevention) have published guidelines and recommendations for successful weight loss. Of course, they all recommend a reduction in calories, foods that are high in nutrients, and physical activity.

Nurses will encounter overweight people in nearly every setting. So, it’s appropriate for nurses to initiate discussions about the importance of maintaining a healthy weight. They also need to be aware of the array miracle weight loss pills in order to educate others. Nurses can participate in health fairs to learn about the potential dangers of weight loss pills and to learn of healthy lifestyle guidelines. Nurses should definitely set a good example of their own health because they can highly influence their patients' lifestyle decisions!



http://www.fda.gov/womens/getthefacts/supplements.html
http://www.fda.gov/consumer/updates/supplements080408.html
http://www.psychiatrictimes.com/display/article/10168/54321
Welch, C.B., from Diabetes Forecast, 4/1998, Vol. 51 Issue 4, 40-46
Christensen, R., Kristensen, P.K., Bartels, E.M., Mitchell, P.B., & Morris, M.J., from Neuropsychiatry Reviews, 12/2007, Vol. 8 Issue 12, 20.
Mitchell, P.B., & Morris, M.J., from The Lancet journal, 11/17/2007, Vol. 370 Issue 9600, 1671-1672.
http://www.fda.gov/bbs/topics/news/2006/NEW01298.html
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html
http://www.fda.gov/fdac/features/1999/699_fraud.html
http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm

Controversy & weight loss drugs in the media

Weight loss is a huge issue for millions of people, and weight loss drugs have always been covered widely by the media. Newspapers magazines and television newscast all have reported the many myths, problem and successes with these over the counter and prescription drugs.

In an article from the New York Times Weight Loss Drugs, "Hoopla and Hype," published April 24, 2007, the many effects and misconception from over the counter weight loss supplements are discussed in detail. This article says that in a telephone survey “more than 60 percent mistakenly thought that all such supplements had been tested and proved safe and effective; 54 percent thought that the Food and Drug Administration approved the remedies.”

The truth is because these drugs use natural ingredients they do not have to submit any evidence of the safety or effectiveness to the food and drug agency because of the Dietary Supplement Health and Education Act that passed in 1994. Can you believe that!?! Millions of people take these supplements hoping they will lose the weight but instead all they gain is high blood pressure and heart problems. Even the prescription drugs have had limited success. You should discuss with your doctor the risk and benefits of these drugs and realize that they are an aid in weight loss and should not be used long term or as your only method of weight loss.

Health Magazine talks to a woman who used a friend's Ritalin (attention deficit hyperactivity disorder medication) to help her loss some weight. Even though she did this without a doctors approval (NOT recommended), some doctors have prescribed many drugs for weight loss that are typically for the treatment of other things, from depression all the way to seizures. Off- label prescribing come with its own set of risk even though these drugs are FDA approved. It is not for the causal dieter and should only be used at the recommendation of your doctor in combination with a healthy diet and exercise.

A Newscast video from abc.com reports that weight loss drugs are ineffective. Long term clinical trials found that obese people on one of three popular weight loss drugs (Meridian, Xenical, and Acomplia) lost only around 10 pounds even with drug treatment. Those on Acomplia had an increase in mental health problems, such as depression and anxiety. Acomplia is only available in Europe and was denied approval by the FDA because of the mental health issues. The approved drugs do have some benefit because a small loss in weight can improve blood sugar and cholesterol levels, but don’t expect a huge change in your appearance.

Have you noticed a common thread though all three of these articles? Doctor’s approval, healthy diet, and exercise. It takes a commitment from you to lose weight. There is not one miracle sit-on-your-behind-while-the-pounds-melt-off drug, but a true lifestyle change to a healthier life. Under the right care, a weight loss drug can AID in your journey to a healthier life - not replace diet and exercise.



New York Times, Weight loss Drugs: Hoopla and Hype
http://www.nytimes.com/2007/04/24/health/24brod.html?_r=1&scp=1&sq=weight%20loss%20drugs&st=cse

Health magazine, The New Diet Pills
http://living.health.com/2007/04/01/the-new-diet-pills/

ABC, Weight Loss Drugs Ineffective
http://abcnews.go.com/search?searchtext=weight%20loss%20drugs&from=0&to=9&type=video

Scientific Data: The straight dope on weight-loss drugs

Despite abundant advertising hype, no drug (and no "natural" herb) offers a magic bullet against obesity. There are some new drugs though that may provide support in a balanced weight-loss program.

"Although Americans would like to have a pill to cure obesity, the best that will ever be available is something that will contribute to a lifestyle effort and make it less of a struggle," says Madelyn Fernstrom, PhD, director of the Weight Management Center of the University of Pittsburgh in Pennsylvania.

By Prescription Only
The three most-prescribed prescription drugs are:
* Xenical (orlistat), approved by the Food and Drug Administration (FDA) in 1999. It interferes with the digestion of fats and prevents about 30 percent of the fat that you eat from being absorbed by your body.
* Meridia (sibutramine), approved in 1997. It boosts the levels of two neurotransmitters--norepinephrine and serotonin--in your brain to moderate hunger cravings and give you a feeling of fullness.
* Phentermine (available under Ionamin and Adipex-P), approved in 1957. Phentermine suppresses appetite by boosting norepinephrine levels. It is approved only for short-term use.

Over-The-Counter Options
The only FDA approved OTC weight-loss drug is Alli, which only works if the consumers follow a strict regimen of diet and exercise.

Beware Herbal Remedies
For the most part, the only diet medications now available without a prescription are herbal and other "natural" preparations. Dietary supplement manufacturers do not have to tell the FDA about adverse effects, and the product labels aren't good either. Conventional physicians and researchers consider most of them useless and some of them dangerous. "Herbal remedies are not well supported at all by clinical-trial data," says Belinda O'Connell, MS, RD, LD, a clinical dietitian at the International Diabetes Center in Minneapolis, Minn.

"Although they may look like medicine, herbal weight-loss remedies are neither effective nor - in some cases - safe," says Madelyn Fernstrom, PhD, of the University of Pittsburgh.

The FDA believes these people were wasting their money and risking their health. "Only a few herbal weight-loss remedies have been tested in clinical trials, generally with no evidence of benefit," notes Samuel Klein, MD, of Washington University in St. Louis, Mo.

For example, Ephedra's potential side effects can include high blood pressure, irregular heartbeat, stroke, and seizures. A scientific measurement of the ingredients of 20 ephedra brands found that in half, the label was wrong by more than 20 percent. One brand had 10 times the amount of ephedrine alkaloids stated on the label. Another had none at all.

"Laxatives and diuretics may make people think they have lost weight, but it's only water weight," says Fernstrom. "They're not thinner, just dehydrated."

CHECK OUT THE FoxNewsChannel VIDEO HERE as well as the video posted below!



Fentress, D., & Agnew, B., from Diabetes Forecast, 4/2002, Vol. 55 Issue 4, 51-55.

Since when have dietary supplements been a hot topic issue? Why? Who all should care?

For decades, the Food and Drug Administration regulated dietary supplements as foods to ensure that their labeling was truthful and not misleading. An important facet of ensuring safety was FDA's evaluation of the safety of all new ingredients, including those used in dietary supplements, under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

However, it's been a hot issue ever since the passing of the Dietary Supplement Health and Education Act in 1994, in which dietary manufacturers must make sure their product is safe and that their label is true and not deceptive. Dietary supplements are not regulated like pharmaceutical drugs or a food item, which means that manufacturers do not have to promise the ingredients of their products. This lack of regulation means that anybody can put their product in the market and could have too much of an ingredient or too little. We all know that having too much of a ingredient can be harmful to our health along with using dietary supplements to substitute for a meal or pills prescribed to us by our doctor. It is important for doctors to know if their patient is taking any of these “natural” supplements to avoid any drug interactions. Even though these supplements are considered “natural,” they may not completely be safe for everybody. It is important for consumers, nurses, and doctors to be aware of the myths regarding these supplements and the harmful effects they have can towards the individual. Can you believe that the use of dietary supplements is worldwide and over half of Americans take them? It is crucial for consumers to consult their nurse or physician regarding any dietary supplement.

http://www.dshedu.com/DSHEA_Legal/dshea.html
http://www.fdareview.org/glossary.shtml
http://www.gain-weight-muscle-fast.com/image-files/dietsupp.gif
http://www.gyroworldwide.com/site_images/Hot-Topic-Logo_v2.jpg

Be proactive and do your research!

To check out a product, FDA health fraud coordinators suggest:

Talk to a doctor or another health professional.
Talk to family members and friends.

Check with the Better Business Bureau or local attorneys generals' offices to see whether complaints have been made about the product.
Check with a health professional group (American Heart Association, American Diabetes Association, National Arthritis Foundation, etc).
Contact the FDA office closest to you, or go to www.fda.gov/ora/fed_state/dfsr_activities/dfsr_pas.html.



http://www.fda.gov/fdac/features/1999/699_fraud.html

Diet danger? How the FDA feels!

FOX News released an informative video on December 23, 2008, regarding the FDA investigation of over 30 weight loss drugs containing hazardous ingredients. Click here to view!

Dr. Robert Ashton warns consumers of weight loss pills that the “ingredients in a lot of these dietary supplements that seem to be coming out of China but it's not actually listed…They can cause problems especially for people with heart related illnesses. So, the bottom line is: Do not take any dietary supplements for weight loss without a doctor's prescription and under his care. Zero. No question about that."

These weight loss pills are often called the natural fat busters and that sort of thing and people think, “Oh, if it's natural it's got to be good for me and not even dangerous."

"Well a lot of things are natural – we always talk about how marijuana and cocaine are natural substances but I don't think they're good for you. So, the answer is the only natural dietary supplement that I recommend is water. Drinking water instead of calorie juices and drinks is probably the best weight loss. Any dietary supplement that has weight loss attached to it, do not take without consulting a doctor.”

http://www.foxnews.com/video-search/m/21707789/diet_danger.htm#q=weight+loss+pills

Meaningful Quotes: What the experts are saying!

Sidney M. Wolfe, M.D., Director of Public Citizen’s Health Research Group, Washington, D.C.: “No diet drug has ever had any evidence of long-term benefit.” He points to previously FDA-approved drugs like Dexatrim, which were eventually yanked off the market. “We’ve always advocated that the only way to lose weight is very slowly,” i.e., about a pound a week through diet and exercise. “Unless you believe in magic, these pills or crash diets don’t work. The history of over-the-counter weight-loss drugs is pretty grim.”

Caren Feingold Tishfield, R.D., Nutritionist at Foodtrainers, New York City, NY: “Historically, weight-loss medications have helped people lose weight, but there are important caveats. “If a weight-loss drug can help someone get on track with living a healthier lifestyle, and [it is] used in the short term, then there’s a place for it.” But the drugs “can't be used in place of changing your diet and exercising.”

CHECK OUT THE ABC News VIDEO HERE ("Diet Pill Myths Debunked")!

http://www.revolutionhealth.com/articles/alli-ticket-to-slim-or-empty-promise/article.2007-06-12.9891775917?ipc=B00497&section=section_00