FDA approves obesity pill Belviq for obese, overweight people with weight-related health problems

(CBS News) The obesity pill Belviq (lorcaserin) has been approved by the U.S. Food and Drug Administration to be used in conjunction with diet and exercise as a weight management treatment option. It's the first new long-term weight loss drug to hit the U.S. market in over a decade.

The FDA announced Wednesday that the drug is approved for adults with a body mass index (BMI) of 30 or over - which indicates obesity - or with a BMI of 27 or greater (overweight) who have at least one weight-related health problem such as high blood pressure, Type 2 diabetes or high cholesterol. It is manufactured by Switzerland-based Arena Pharmaceuticals.

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"Obesity threatens the overall well being of patients and is a major public health concern," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a written statement. "The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition."

There are currently two prescription drugs used to treat obesity including the appetite-suppressant phentermine, and orlistat (Xenical), which prevents dietary fat from being absorbed by the intestine. Orlistat is sold over-the-counter as Alli in a lower dose.

The FDA cited three studies of nearly 8,000 overweight and obese patients - with or without Type 2 diabetes - who were treated from 52 weeks to 104 weeks with the drug or a placebo, along with exercise and diet counseling. The studies found about 47 percent of patients without Type 2 diabetes lost at least 5 percent of their body weight compared with about 23 percent of patients treated with placebo. In people with Type 2 diabetes, about 38 percent of patients treated with Belviq lost at least 5 percent of their body weight, compared to 16 percent in patients treated with placebo.

The drug's label will recommend that people stop taking the pill if they don't lose 5 percent of their body weight after 12 weeks of treatment, as those patients are unlikely to achieve meaningful weight loss even with continuing treatment. The drug should also not be taken by pregnant women.

Side effects from Belviq include serotonin syndrome - a potentially life-threatening drug reaction that causes the body to produce too much serotonin and causes symptoms of agitation, diarrhea, heavy sweating, fever, muscle spasms, tremors or mental health changes. People taking antidepressants or migraine drugs that increase serotonin levels may be at an increased risk for this side effect. The drug may also cause "disturbances in attention or memory," the FDA said.

Belviq should be used with caution in people who have congestive heart failure, according to the FDA, but studies found no significant difference in heart valve problems between people taking Belviq and those taking a placebo. Studies of some earlier weight loss pills reported heart valve damage as a potential side effect.

Arena will be required to conduct six postmarketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for major cardiac events such as heart attack and stroke, the FDA said.

In May, a panel of expert advisers to the FDA voted 18-4 with one abstention to recommend the agency approve the pill saying its benefits "outweigh the potential risks when used long term."

The pill was initially rejected by the FDA in 2010, which called any weight loss the drug produces in overweight people who don't have diabetes "marginal." FDA scientists also raised concerns about health issues such as tumors that developed in laboratory animals given the drug.

Earlier this year a rival drug, Vivus Inc.'s Qnexa, won endorsement from an FDA panel after previously being rejected due to safety concerns. The drug's approval is currently pending.

[rachelsteve86]

While suffering from obesity we have been took many steps to get rid from these worst problems, therefore many diet programs as well as diet pills are being intake at regular intervals.

But in somehow intake of diet pills are puts a negative impact on our health, here we can found that scientifically it can proved and FDA also approves the consume of diet pills are now proved effective for human health.
www.medifasthealth.org/blog/working-medifast-coupons/

[DrRudefriend]

The horrific side effects of this "miracle" drug should remind us that there's no magic solution to weight loss, and no such thing as a free lunch. As I discuss in my book, Lose Weight with Dr. Rudefriend, accepting those facts is the first step to changing our minds about food and our weight, and therefore the first step toward doing what's necessary to actually lose weight. As long as we keep telling ourselves that there's a magic solution, we'll never lose it.

[gkierkegaard]

Wow! Talk about misrepresenting the product. The nuances of how something is stated make all the difference in the world.

Here's the exact quote from the FDA site:
Treatment with Belviq may cause serious side effects, including serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors. These include, but are not limited to, drugs commonly used to treat depression and migraine.

Note the word "particularly".

Since Belviq works by targeting a serotonin 2C receptor in the brain, the FDA first warns that there is a general concern for serotonin syndrome--which is true of any drug targeting a serotonin receptor. The FDA then proceeds to state that the real concern is if/when Belviq is mixed with other serotonin targeting drugs: "particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors."

By contrast, the CBS article gives the impression that Belviq clearly acts as an independent agent to create serotonin syndrome, as though, for example, serotonin syndrome (or signals thereof) showed up in the testing phase. Nothing could be further from the truth!

Either this wording is intentional by the author or the author doesn't understand the nuances of writing and logic!

[Bojax39]

"It's the first new long-term weight loss drug to hit the U.S. market in over a decade."

Didn't the last one maim or kill people before being pulled from the market?

FDA approves all kinds of poison while letting people languish in illness when they could be helped by legalizing cannabis.

Morons

[paracsi7]

It seems that I am in their "box" to partake of this drug - however I do not believe in chemically induced weight loss. I have been with the Biggest Loser Club online site and have managed to lose pounds even though it has taken quite some years-from 185 in 2007 to 167 in 2012 - in between there have been losses and gain and plateaus - frustrating but I stuck with it amongst a great support system that included a nutritionist and a fitness expert-and yes I did not always do enough proper exercise everyday. I also have diabetes, high cholesterol, hypothyroidism, so it was important to get a handle on mt life and move to a better style-one was a book called Coach Yourself Thin by Greg Hottinger and Michael Scholtz - a book to learn how to adapt to a healthier lifestyle andovercome all those doubts along the way - second was a personal trainer at a gym in my city who has helped me with routines and made me be consistent - also following a good nutrion plan and making proper food choices - I started in January 2012 and as of June 2012 I have lost 12 pounds, inches, my A1C went to 5.0 from 6.1 (Sept 2011), cholesterol went to 166 from 199 (Sept 2011), and I feel great - the exercise is hard work, lots of effort, and also lots of fun!!!!! So if you truly want to lose weight get up off your BUTTS and get moving - eat good food, quit smoking, watch th alcohol, and you will feel much better and look great - it takes time - if you want a quick fix - sorry they do not work!!!

[magnumdr]

The FDA is one of our Country's biggest drug dealers making so many drugs legal to take for weight loss and other things. People can do without these drugs!. What a drug taking Country we have become. Make all of these non needed drugs illegal and make people stop taking all of these drugs for things we can do ourselves without any help from a drug!

[jtdev1]

Why does one have to spend money losing weight?

I found that I saved a huge amount of money NOT EATING LIKE A PIG.


Nobody has will power anymore and thats the problem.


HFCS yes, is GARBAGE but just don't eat it or anything with it in it.

Fresh Veggies is all you need, No problems.

Just completely STOP all processed FACTORY FOOD and you'll lose that fat and feel better, happier and more energy.

[LinRavenWing]

That is a wonderful idea! Will power is a fantastic thing and everyone should use it. Unfortunately money does not simply fall from the sky and this year more than any other, fresh veggies are costing more and more. What about the minimum wage slave who can barely afford a place to live, which is more than likely a single bedroom unit in some horrific location with very basic amenities, their utilities and a way to and from work? There is no way a person who is in a situation like that can possibly afford all the fresh veggies in the world when they have, what, $20 to live on for the month? Ramen is terrible, but it is better than starving to death.

[mswallace1]

I know that there are many drugs to help people who are overweight, I have had 4 children and now weigh less than I did 25 years ago when I graduated high school and I have used no drugs to get to where I'm at now. I have watched my calorie intake and just cut back and drank lots of water. I have 2 daughters with small children and they to have done this with out drugs and still are losing there baby weight. It can be done with out the drugs you got to know how to do things the right way

[charbmoore]

I still maintain that the problem for most over weight people is not hunger. People who reach the obesity level are not eating because they are hungary. If you have someone determined to diet and exercise, a pill to reduce hunger may be useful, but they still need to find the chemical in the brain that drives some people to eat way beyond hunger satifaction.

[akibeel]

and a year later when this product eats your liver, makes you grow some sort of tumorous cancer they'll recall it...