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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.
Related stories:
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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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""Thirteen years without any other medical option."
There are options such as diet and exercise that the government refuses to even consider supporting. The FDA will promote toxic drugs (how many advertisements do you see for lawsuits over death from a prescription drug - when death and other serious side effects are clearly stated, yet still get FDA approval?), yet goes after herbal and alternative remedies like they would cause the plague.
Clearly, drugs aren't the answer to every question.
Instead of approving another drug that will probably be recalled in a few months anyway, shouldn't the FDA just do its job and regulate the ingredients companies and corporations are putting in our food and drinks that are making us fat and sick? I still don't understand why one administration regulates the safety of our food and drugs; is it because foods contain so many additives they no longer fall under the category of food?
Well now that's just plain silly. Who's gonna make money off that? That would actually SAVE money, by knocking out all kinds of harmful additives, and also by likely improving the health of this country. Are you crazy? That's not how things work. Keep people sick and fat, raise the income of the drug companies, medical businesses, etc.
And by that same (and hopefully sarcastic) logic is why I've come to the conclusion that vaccines aren't really healthy :-)
Don't get me started on that one!! It appears that so many diseases were nearly wiped out with the initial vaccines (the ones that actually stopped polio, etc.) that someone had to do something to start a whole new rash of illnesses.
I agree, how is an individual to win a battle when the foe is a conglomerate corporation with millions to spend in R&D to figure out how to make people consume more of their products? The government should be there to be for he people when the manufacturers are not doing things with our interests in mind. Instead the corporation's run government with their PAC money and lobbyists...Just wonderful, the US government who is supposed to be there to help us is are no better than Mexican cops taking payoffs from the drug cartels to keep the guns and drugs flowing.
NOW, I understand the conspiracy theories, because this stuff just doesn't make any sense.
Arena is soaring today on the FDA's approval of Lorcaserin. In case anyone is looking for a sympathy play, ChromaDex's (OTC:CDXC) pterostilbene () and NR () compounds are also related to weight loss and have some great study results.
I have a great weight loss pill for you.
Stop eating enough food for several people
Get off of your fat a$$ and burn some calories
Have your hormones checked
Do you know what a hormone sounds like? HAHAHA
Dear Al,
I can lose weight. You, however, will still be a judgmental moron. You had best hope that you never need anyone's help in your life because if your comments are an example of how you treat them, no one will every come to help you.
Just make a pill that makes me not HUNGRY 24/7.
I have a good friend who said he was always hungry - I didn't get it, because I can easily skip a couple of meals, and he said he couldn't go more than an hour or two without getting hungry. He's tried many diet approaches, and has found that Pritikin (small amount of meat, mostly vegetables and starches) has turned things around for him. He's lost weight and the hunger is totally under control. He said the main thing is that we need a little fat in our diet every day - when he went fat-free, his appetite was out of control. A little fat (mostly olive and coconut oil while cooking) changed something in his brain, and the hunger abated quite a bit.
I've never had a problem with weight, or with hunger, and I've also never cut out fat - keep it balanced.
Just thought this might help you.
it'sme,too;
Thanks for the information. I to don't have a weight problem. I Really have to exercise to keep the weight from the food that I do eat off. Sometimes I just feel like duct taping my mouth. Thanks again.
rfrisch
The pill you re seeking is called Will Power
That's my point - if your brain isn't fed right, your body doesn't respond properly. I always thought it was lack of willpower, because I never had that problem. If you're constantly hungry, you have no willpower.
And this goes back to modern-day food being practically stripped of all nutrients; I smell a conspiracy boiling! Oh, wait.. that's just fumes from all the chemicals in our drinking water...
All these people saying nasty things about overweight people don't know a thing. For the last 30+ years our gov, doctors and everyone on TV and in the bookstores has been telling us to eat a high carb/low fat diet. Yesterday someone finally published a study, that showed that diet was the worst possible diet ever. If the link doesn't show just Google Low Carb Diet Burns the Most Calories.
We've been told the wrong information for decades and we are a fat nation because of it. I know that eating a diet with fat and protein is better for me than eating breads and pastas and other processed foods and yet I have had hammered into my brain that I need a low fat diet to lose weight. It's wrong.
So stop shaming these people, eating carbs is addictive and we've been told to eat them for years. Getting off of them isn't going to be easy.
I wouldn't touch this medication with a 10' pole. It will be like the others, they pull it from the market after a slew of people die from taking it.
More than anything our American lifestyle of sitting, sitting, sitting is taking its toll on a huge sector of our society. To those who laugh and think it's so easy to lose weight, let's hear from you in a few years when you've put on a few pounds. Most Americans gain weight as they get older. The worst part is that we have a whole new generation of kids that is being taught to manage their lives from a sitting position with cell phones, video games, online shopping, tv, etc. We will see heart attach and strokes happening at higher rates among lower and lower aged people (we already are).
You can't just take a walk and eat a little less. To genuinely be healthy and lose weight you have to be willing to give your entire lifestyle a makeover. If you don't, you will always gain back what you lose plus more. Every individual has to make the choice - and it's a hard road but it's your life at stake.
And what happened with the last weight loss pill they okayed? To quote Axl Rose, "Time to Dieeeeeeeeeeeeee!" Eat raw fruits and vegetables people. Drink water too! F#@k pills!
If you've never hd to fight that battle, you can't possibly understand.
It's far easier to laugh at us and make fun of us that for you to try to learn compassion.
I have been on and off diets for most of my adult life. I have gained and lost hundreds of pounds.
But it's a fight, and you feel deprived, and depressed because you feel like a failure if you cant stick with it.
I'm not talking about 10-20 pounds..sure that takes effort but it's not major.
I'm talking about being morbidly obese when you eat the same food as someone who is considered "normal size" and being a fairly active person and still not able to lose weight.
So be fore you judge us. Stop and think BEFORE you speak. There may be more going on than you know. Not all "fat'' people are lazy or stupid.
if it were easy anyone could do it...
besides, rabbits, hippos, moose, and cows are all vegetarians and they aren't skinny..
You are they type of person these pharmaceutical companies are preying on. Watch a documentary titled, "Fat, Sick and Nearly Dead". It shows you the benefits of juicing raw fruits and vegetables. It helped me lost 30lbs in my initial two months and the only side effects are good health and energy. I hate to see these companies making billions while killing innocent people who could have changed their situations through lifestyle changes. I hope you try it and I hope you succeed! :)
AAAGGGGHHHH. I am not overweight because I AM HUNGRY. I am overweight because I eat when I'm hungry, when I'm sad, when I'm happy, when I'm bored...and the list goes on! When will the world realize this fact?
It is not: hungry = overweight If that was the case, I'd be as skinny as a board!
Didn't they approve Allie a few years ago?
Instead of worrying about it, just change your mindset. Women are fine if they are under 200 lbs and men are OK if they are under 300 lbs. Times change. God bless America.
Is that a misprint? 3 - 3.7% of body weight? I can do that tonight if I want to use the wrestler's workout. I want to lose 20-25% of my body weight. No point using a drug that can have unhealthy side effects when really, just like everyone else in my boat, I need to cut down the calories in and ramp up the calories burned. There is no magic pill and there never will be.
Topic: Water table poisoning.
I used to be worried about the amount of birth control medication is urinated into the earth's ecosystem, it would be a tragedy if all animals including people started to have issues with getting pregnant.
Now I have even more to worry about...If this pill sells like sliced bread, is absorbed no better by the human body as other drugs, does not degrade any faster than other drugs, then all animals would lose their hunger and feel fuller on very little food, that would upset the ecosystem to an even greater degree!
My thing is this: Ive watched the show BIGGEST LOSER they work their butts off week after week, and sometimes on the weigh ins they only lose 1 lbs. that is heart breaking!!! its about your motabolism and how it targets your fat!! Id expect to lose 5 pounds every damb time if im going to sweat like those people do!!! I just started SENSA 2 days ago!! im drinking more water, eating salads, no bread or potato, trying to walk, I live in Tuc its HOT!!!!! when i come home from work, last thing I wasnt to do is walk in the 108 temp! no money for a gym. so i do what I can!! wish me luck!!
Check out some fitness DVDs like Insanity and Jillian Michael's 30 Day Shred. Since you watch Biggest Loser, I'd suggest the 30 day shred. I've seen pictures with amazing results from that. Also, look up which foods speed up your metabolism. :) GOOD LUCK!!
Insanity DVD's are for people younger than 30...Nobody in their middle age could perform those moves and not bust themselves up seriously...I have heard this from trainers who have many stories of people not understanding their limitations.
Skunky-
Good to know. 30 DS isn't nearly as intense as insanity, though.
Another option is buying a jump rope. It burns tons of calories! I'd suggest buying some good shoes if you're going to jump rope a lot, though, as the impact can be brutal.
I believe the key words to this drugs success is " All participants agreed to diet and exercise regimens". A dominant problem with obese individuals is they loose inspiration and the required mindset / motivation. Anouther pill that will help you loose weight but give you rectal bleeding probably isnt the answer.
The FDA is a joke and has no cred!
Why are 2/3 of Americans overweight or obese it's because of what we eat. It's cheaper to be fat than thin in this country. We have put so many chemicals in our "food" that it is no longer food. If i can't pronouce it I don't eat it. I'm growing my own veg so no chemicals there I try and eat organic meat etc but it's so expensive (remember when organic food was just called food).
This is for Rusty Trombone. With your personality, I'm sure your trombone is rusty!
I just invented a pill that will make you smarter and do better in school, although it does require you to study in addition to taking the pill.
i am very confused , the new drug over 6 months to one year on the average lost 3% to 3.7% with diet and exercise. They are going to give the drug for 12 weeks and if the patient has not lost 5% of their body weight that they would not do good on the drug? Something sounds wrong here?
Exercise is the key to losing weight and maintaining your ideal weight. I think that is where most people struggle.
Did you read the article? "All participants agreed to diet and exercise regimens." Last time I checked you could achieve the 3-5% weight loss by doing just these things. No magic pill required.
AAAGGGGHHHH. I am not overweight because I AM HUNGRY. I am overweight because I eat when I'm hungry, when I'm sad, when I'm happy, when I'm bored...and the list goes on! When will the world realize this fact?
It is not: hungry = overweight If that was the case, I'd be as skinny as a board!
I don't understand why they keep attacking the brain when it comes to weight loss. What they need to do is develope a drug that attacks fat cells & fat cells ONLY. This would elimate the need to curb hunger & excercise for those who just don't want to excercise. Some of us don't care to have 6 pack abs we just want to fit into our clothes better & not have to shoot up insulin twice a day.
I'm pretty sure they've been trying to develop a drug that attacks fat cells...probably since day one. I imagine it's not a simple task.
This is kind of hilarious. Lose 3% by taking a pill in addition to diet and exercise? People are idiots if they are buying this. It's like the cellulite-reduction cream that tells you to massage it in 20 minutes, 3 times a day. That's an hour-long massage every day. With that kind of massaging, I hardly need the cream to get rid of the cellulite!! Brilliant advertising however, b/c you can't sell "massage your butt for an hour each day." Just like you can't sell "diet and exercise." You gotta give the people a pill or a cream so they feel like they are getting their money's worth. I am 34, 5'7, 118lbs. Have gained 3 lbs since my college days. I do not even exercise regularly. I just take the stairs whenever possible and mostly eat organic/natural whole foods, cooked by myself at home. Soda pop is a big no-no. Don't drink any kind - diet, caffeine-free, etc. That stuff is just awful in every way. There are so many sugars, hormones and pesticides in the food we eat today (also FDA-approved), that they are messing with our metabolism and thyroid function and we don't understand why we can't lose weight even while on a diet. Go natural/organic/unprocessed. Cook for yourself at home. You will notice the difference.