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Subscribe to RSSBelviq, the first weight loss pill approved by the FDA in 13 years, works by activating a receptor in the brain that helps people feel full after eating. Despite concerns about the drug's safety, the FDA and many doctors feel the drug's benefits outweigh the risks. NBC's Robert Bazell reports.
Federal Food and Drug Administration officials approved a new weight-loss pill Wednesday, giving the nod to Belviq used in combination with a reduced-calorie diet and exercise to combat obesity.
The Arena Pharmaceuticals drug, which also goes by the generic name lorcaserin, is one of three new potential weight-loss treatments the agency is considering and the first new weight-loss medication approved in 13 years. More than two-thirds of adult Americans are overweight or obese.
"Obesity threatens the overall well-being of patients and is a major public health concern," said Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research.
Lorcaserin was initially rejected because of concerns about safety issues, particularly concerns about heart valve problems, but a panel this spring agreed that the drug from Arena in conjunction with the Japanese firm Eisai Inc. was now suitable for use.
The drug works by activating a receptor in the brain that may help a person eat less and feel full after eating smaller amounts of food.
It is approved for use in obese adults with a body mass index or BMI of 30 or greater and in overweight adults with a BMI of 27 or greater if they have at least one weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol. For example, a 5-foot-7 woman who weighed 192 pounds would have a BMI of 30.
The drug was tested in three randomized, placebo-controlled clinical trials involving nearly 8,000 obese and overweight patients, including those with and without type 2 diabetes. They were treated for 52 to 104 weeks. All participants agreed to diet and exercise regimens. Compared with use of a placebo, or sugar pill, patients treated with Belviq for up to one year lost an average of 3 percent to 3.7 percent of their body weight.
Nearly half of patients without diabetes lost at least 5 percent of their body weight, compared with about a quarter of those who took placebos. In people with diabetes, about 38 percent treated with lorcaserin lost 5 percent of their body weight, compared with about 16 percent treated with placebos.
The drug is recommended to be discontinued in patients who fail to lose 5 percent of body weight after 12 weeks of treatment because they appear to be unlikely to achieve "clinically meaningful" weight loss.
Approving lorcaserin will offer big benefits to patients approaching the 30 BMI mark, which increases health risks and decreases the likelihood of future weight loss, said Dr. Jaime Ponce, the new president of the American Society for Metabolic & Bariatric Surgery.
"I think this is great," he said. "Thirteen years without any other medical option."
Select patients treated in a program that includes diet, exercise and medication may be able to lose weight without resorting to surgery, he added.
Arena Pharmaceuticals will be required to conduct six post-marketing studies including a long-term trial to evaluate cardiovascular risks including heart attacks and stroke.
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- Could weight-loss surgery help end diabetes?
- Desperate to qualify for weight-loss surgery, some pile on pounds
A woman who was desperate for lap band weight-loss surgery had to gain weight to meet qualifications for the procedure that would ultimately help her shed the extra pounds. NBC's Kristen Dahlgren reports.
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It is so sad when our Nation wants to sin tax other sins, but not gluttony. And yes, before you say I do not have a heart or compassion, I do. I realize that a small amount of people have health problems that cause them to be obese. However, we as a Nation, are so intent on putting down others for their bad choices and then excusing our own bad choices with lame ass excuses. Do you not think looking for every miracle pill that comes down the pike that has just as many bad health effects as the sins in others they put down is hypocritical? All these "diet" pills are dangerous! Don't do it! Let's stop judging others critically and giving ourselves a pass. Gluttony and laziness in large part causes obesity. Stop with the sodas, sweet teas and switch to water; walk instead of driving everywhere; take the steps; cut your portions; pick healthy snacks and put down the donuts! We need to all be more compassionate to our fellow man. Just because the food "drug" is legal and acceptable, does not make it any less a drug. Isn't it funny that those persons who put down alcoholics are those that do not drink or are former drunks; those who put down smokers are nonsmokers who are fat/alcholics/formers smokers; those who put down the obese are pot smokers/former heavy persons/alcoholics/lazy? People put down others to feel better about their own weakness. Keep trying, you can lose weight and do not take drugs to do it. Keep trying smokers, you can quit, but do not eat more to do it....keep trying alcoholics, you can quit drinking...
2 years from now the headline will read, "Belviq Shown To Cause Cancer, Study Says".
This is great news and it comes with regulations to the patient that they can't use it if they are going to tey to quit eating. I got to lose 10 more pounds and I'll be good to go. However, I am not depending on a miracle drug. My weight loss plan is common sense. If it is white, leave it alone. This means for 12 to 16 weeks you cannot have sugars or starches. I walk a mile at leisure daily, but not all at one time. My dog usually drags me 1/2 that. You always have to have a long term plan. Where do you want to be like next year. And the short term plan. I want drop 20 lbs. You aren't going to be at you long term plan weight for along time, so make short goals to work on. Then after you decide that you have lost most the fat, put about 1/100th of starches back in your diet gradually building up to no more than 1/4. Then ocassionally have the sugars. When people quit eating fats and sugars, then they will be more healthy. If you diet, don't substitute sugar with a diet sugar. diet sugars make you eat more.
It has caused brain tumors in experimental animals, so it is not supposed to be approved for use in humans according to the Delaney Amendment. Leave to the FDA to approve yet another drug that will kill us. I lost 130 pounds and I have kept it off for three years now. It isn't easy, but it can be done without dangerous drugs.
CONGRATULATIONS! I know that wasn't easy!
If they say people should eat less and exercise along with taking the pill, why the hell do they need to take the pill?? Eating less and exercise is all you need. When they come out with a pill that burns Fat without diet and exercise, then That is a weight loss pill otherwise it's the same old crap.
This article doesn't make sense to me. 3-3.7% weight loss in a year? I've been on WeightWatchers since January and I've lost 5% of my weight.
And the pill is prescribed with a low calorie diet and an exercise program? Isn't that the basis of any weight loss program?
And for all those who love to make disparaging remarks about the obese, there is a lot more than eat less/do more to lose weight. Some people drink to mask pain, some people eat. Some people just don't have a handle on nutritious food. It's not always a sign of laziness or gluttony.
this is such GARBAGE!!!! Wake up America and get of yer fat asses and work for it!!!
Bets on how long this lasts before it starts to kill people and they pull it off the shelves amid another round of class action lawsuits? That's happened with every other weight loss drug they've ever approved so it's just a matter of time.
This pill doesn't sound like much of a breakthrough -- did I read the article right? That people taking it lost on a whole 3.7% of their body weight over a year's time? Well, for example, if someone who weighed 200 pounds, that's what? Not quite 8 pounds? Big deal. You go from 200 to 192. You're still fat. That's not even enough of a weight loss to make a person move down to a smaller size in clothing. Sounds like a lot of marketing hype that includes some significant risks (heart valve problems) for not much in the way of actual results -- and if you're supposed to combine it with exercise and a healthier diet, how does anyone know that it's actually the pill causing the weight loss? Maybe just walking a few more minutes daily and eliminating some junk food would have the same results.
I am concerned about the safety of this drug. What are the long-term side effects? Could cause cancer, who knows! Same with all new drugs. It's not safe just because the FDA says it is.
So after a year on this med you only lose approximately 3.5% of your original weight, people would lose more in a year just by regularly skipping a meal.
Skipping meals is a big no-no for weight loss. It slows your metabolism down, and if you don't eat enough, your body goes into starvation mode and starts hoarding all your fat for reserves.
Really? is that why all those starving people in Africa are so fat? because skipping most of their meals is causing their bodies to "hoard fat"?? You can only hoard fat for so long. Eventually your body will start to burn it off for energy. Not saying it's healthy to starve yourself, but most people in this country could use to eat a LOT less.
Jules-
Yes, really.
Of course you can only hoard fat for so long- it's not like I was saying it's a myth that people starve to death...it hoards the fat and starts to break down MUSCLE (which you DON'T want). Don't believe me? LOOK IT UP.
Starving people in Africa quite frequently have extremely bloated abdomens from malnutrition breaking down their bodies....sounds like a great ideal to strive for, jules....(/sarc)
Ummmm, OK. So some people lost 5% of their body weight. On a 200 pound person that's 10 pounds. Yeah, great drug there. Take a long walk a few times a week and you can do that in a week!
"The drug works by activating a receptor in the brain that may help a person eat less and feel full after eating smaller amounts of food."
I thought we already had this, it is called eat more fiber and drink more water...
You guys want me to walk/jog and eat nasty veggies and fruit , no pizza, no fries and no good ol burgers! YOU ARE ALL CRAZY !! We are in America, we have a pill for everything. now shut up and let me watch my reality show in bed.
Like other people have been saying, to lose weight you dont make temporary changes, you make life changes. So if you lose your weight and go back to your old habits it will grow right back on. So im thinking no one likes the thought of eating healthy for the rest of their life, so how about just eat 'as healthy as you can' and adopt exercise instead. Dont worry about how long per day or how hard it gets your heart beating just somthing fun to do once a day that is active. Even if its somthing simple like riding a bicycle, its not much but over time it will help get you into shape and if you enjoy it then your likely to continue. Once your body adjusts to that exercise you will find yourself not losing anymore weight, thats when you kick it up a notch and adjust your daily habit. Unless your happy at that size then just keep on enjoying your daily bike rides :)
For those who are active and still cant lose weight then adopting a meal strategy might help. I've recently started doing 6 meals a day (1 meal every 3 hours from when you get up) and cutting the portions in half for each meal. So you still intake ~2000 calories daily, but just ~330 calories at a time. It is said to help make your body more efficient, boost metabolism. I felt once my body got into the routine of it I began to have more energy and needed less sleep. My diet has also been very carb rich for muscle gain and I found myself losing weight instead of gaining it. More calories for me! :D
There are some interesting and effective weight-loss natural food derivatives available these days. I really like these because I believe in losing weight by giving the body optimal nutrition for the least amount of calories- to a degree. That is better than weird drugs. Some of these supplements include but are not limited to: raspberry ketones, green coffee bean extract, green tea extract, fucoxanthin, and African mango. The FDA would much rather have you take dangerous drugs.
there is a pill for everything in this country.....I am losing weight the old fashioned way, stop eating everything in sight and excersize....I have lost almost 2 pounds this month alone by cutting out all starches and white sugar...eat only non starchy vegetables, no dairy, no bread or pasta, and some kind of protein 3 times a day....also eat fresh fruit and plenty of water.....
That sounds like a variety of Paleo or Atkins...when you start getting headaches you'll know it's time to add some grains and restore balance. Then you'll start gaining weight back. If you don't mind some advice...go for broad balance instead..meat/milk/grains/fruits/vegies with reasonable fat and calorie limits. That will work longterm, most people can't go longterm on the first two styles. I say most...you'll find out if you can in time. Good luck!
I agree with @sweet equity. You have to have some whole grains in your diet. They provide valuable nutrition and keep you feeling full longer. Try brown rice, whole wheat, maybe buckwheat and quinoa - low in carbs. But cutting out "white" flour and sugars is the right thing to do..
Hello all. 2/3 of the US population overweight, hugh? Come to Maine, and this statistic will seem conservative. Of course diet and exercise trump all in staying trim and fit. But much of obesity is culturally stipulated, as are smoking and other poor choices. And that may be harder to influence than any behaviors. Aa.
That should read 20 pounds.....my fingers got away from me.....
This is one more link in a crazy chain...selling us processed food that will not just make us fat but trick our brains into being too hungry, then selling us pills to trick our brains back into feeling full. And who knows the side effects of this new drug? Someday the demise of our culture will be attributed to the inevitable rise of the unscrupulous under a runaway Capitalist system.
If you simply eat healthily, you will be completely full...read, for example, Dr. Covert Bailey's books on Smart Eating. Nothing new btw...balanced foods, appropriate calorie and fat targets for those many who were never taught those basics. Meanwhile, take a trip to Europe and eat their everyday food...and feel the difference. Even our farm and ranch products are inferior...corporate farms, genetic engineering, reduced variety etc
You couldn't be more right. I was born in USSR and then spent some time living in France. Our products are tasteless here. They get artificially "rushed" to get big, fat, ripe, grown, so they can get sold faster. And because we can't taste anything when we eat, we just eat more to get the satisfaction. In France I could have just a slice of baguette with some butter for breakfast and it was delicious. Here you can go to McDs and have a sandwich and some pancakes, and some hashbrowns and just feel like you stuffed your belly, but not really enjoyed good food...
If you just do the math, you realize that 5% is sooo insignificant. So, if a 200-lb person fails to lose 10 lbs in 12 weeks, they're taken off the medication. Hello! With diet and exercise (which is recommended while taking this pill), they should lose that amount or more WITHOUT medication! The percentages in the studies that were done are absurdly low too! What a scam.
Cool a new pill to kill fat people faster....Thank You FDA (Monsantos) !!!! What is it made from Round-Up spray
This pill has the same defect as all the other pills: you have to take it for the rest of your life. If a pill helps you feel full or keeps you from over eating, what is going to happen when you stop taking it? Some will manage out of habit but others who didn't learn discipline will go a binge. Eat a healthy diet, exercise and be motivated to change your life. When ever I want to break from a healthy life style, I just remind myself of what it is like to be fat and if I ever want to fit into the clothes I love and do the things I love, then I can't have that delicious piece of cheesecake. After I changed my eating habits ( for over three weeks ) and I had a hamburger & fries from Wendy's...my stomach gurgled and made very strange noises for the ENTIRE day! That should tell you how HORRIBLE fast food is for your body. Say with me: "If I want a 6-pack and to have a beautiful body...I have to eat right and exercise." Yes, it's hard but remember, it's NOT a race, it's a marathon that lasts for the rest of your life. It takes as long as it's going to take to lose the weight.
Alexandra, that happened to me recently!! I typically buy natural/local/organic and cook myself at home, fresh uncomplicated meals. One day I was in a hurry to grab dinner on my way home from second job, and picked up some McD's after several months of not having any fast food. My stomach DID NOT like that!! it was weird, I had digestive problems for two days after that... I will never have one of those again... I'll still eat burgers but from nice local restaurants that serve 100% beef, locally grown, etc. Fortunately, there is a new crop of such places opening up due to popular demand. But yes, people need to stop concentrating on speedy weight-loss and concentrate on healthy-living, long term solutions. Anything that sounds too good to be true, is. I am so glad I got a friend from work off her constant yo-yo dieting and onto more of a healthy-eating approach. She is committed to losing the weight a healthy way, even if it takes her several years, b/c this is something she can stick with long-term...
I sure do miss the days of Phen fen. I lost weight at morph speed and did manage to keep most of it off once they ripped from the shelves. Guess it worked a little too well for all the others in weight loss industry.
This drug was only intended to be used for 12 weeks at maximum and then discontinued if no or very little weight-loss occurred. Looking at the whole picture, I agree with the comments here that a 3-3.7% annual weight loss is next to nothing, but some patients will take anything at this point to help them out. The main purpose of this drug is to generate billions of dollars in revenue from all the desperate obese people out there who want an easy pill fix rather than facing the idea of having to eat less and exercise. It's sad to see our standard of health drop so low that we accept obese as the norm. Many people have this idea that they once live once (YOLO!!) and life is short so who cares how I eat? Well, many have forgotten that gluttony is a sin and that to have your health really means something in terms of quality of life. What if the food supply was depleted tomorrow to that of a 3rd world country? Maybe we should count our blessings and not eat ourselves into a nation of poor health.