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Dr. Manny: New FDA approved anti-obesity pill no 'silver bullet'
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The Food and Drug Administration (FDA) approved Arena Pharmaceuticals anti-obesity pill Belviq Wednesday, making it the first federal-approved prescription drug intended to stimulate long-term weight loss in 13 years. The drug is expected to enter the U.S. market within the next decade.
Belviq was originally denied approval in 2010 over concerns that it might cause tumors, but Arena resubmitted its proposal this year with additional data stating that there was little of risk of tumors developing.
Studies conducted by Arena revealed that overweight or obese patients who took Belviq had an average weight loss of 3 to 3.7 percent of their original body weight over the course of a year. Of the patients without diabetes, 47 percent lost at least five percent or more of their weight enough to meet the FDAs effectiveness standards.
I know were in the middle of an obesity epidemic and every effort has to be made to correct this serious medical situation. But while this drug seemed to help in certain patients with the struggle for long-term weight loss, I am still very skeptical that medications are the answer.
I am sure that the FDA has carefully looked at the safety concerns for this pill. However, what worries me is the modest weight loss obtained with the pill.
The FDA has standards for effectiveness, which are usually targets of about 5 percent weight loss or more, but as I mentioned earlier, the data showed that some patients only lost three percent of their body weight. This is a very small amount for a years length of time.
While the pill is going in the right direction, the results of these studies tell me that people should not rely on a pill to lose weight, but instead look at their overall health and lifestyle choices in order to achieve better weight loss numbers.
Remember, theres never a silver bullet for anything in health care.
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Dr. Manny: New FDA approved anti-obesity pill no 'silver bullet'
FDA approves 1st new weight loss drug in 10 years
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(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.
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FDA approves 1st new weight loss drug in 10 years
FDA OKs drug for long-term weight loss
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The Food and Drug Administration has approved Arena Pharmaceuticals anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in more than a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDAs endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.
Obesity Society President Patrick O'Neil said hes encouraged by the drugs approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.
This is good news because it tells us that the FDA is indeed treating obesity seriously, said Mr. ONeil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. On the other hand, its not the answer to the problem or even a big part of the answer.
Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.
The way these things tend to work is you have some people who do extremely well and other people dont lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field, said Dr. Louis Aronne, director of the weight-loss program at Weill-Cornell Medical College.
The FDA denied approval for Arenas drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight-loss treatments.
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FDA OKs drug for long-term weight loss
Belviq: First New Weight-Loss Pill Approved By FDA In Decade
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WASHINGTON The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.
Obesity Society President Patrick O'Neil said he's encouraged by the drug's approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.
"This is good news because it tells us that the FDA is indeed treating obesity seriously," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. "On the other hand, it's not the answer to the problem or even a big part of the answer."
Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.
"The way these things tend to work is you have some people who do extremely well and other people don't lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field," said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College.
The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.
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Belviq: First New Weight-Loss Pill Approved By FDA In Decade
FDA approves first diet prescription pill in 13 years
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by Associated Press
KING5.com
Posted on June 27, 2012 at 12:16 PM
Updated today at 4:59 PM
WASHINGTON -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.
The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.
But a long line of prescription weight loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by FDA.
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FDA approves first diet prescription pill in 13 years
FDA clears first new prescription weight-loss pill in 13 years
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by Associated Press
KING5.com
Posted on June 27, 2012 at 2:33 PM
Updated today at 2:33 PM
WASHINGTON -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.
The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
"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," said FDA's drug center director, Dr. Janet Woodcock, in a statement.
Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.
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FDA clears first new prescription weight-loss pill in 13 years
FDA Approves First Weight-Loss Drug In 13 Yrs.
Long Term Weight Loss Comments Off on FDA Approves First Weight-Loss Drug In 13 Yrs.
WASHINGTON (AP) -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.
Obesity Society President Patrick O'Neil said he's encouraged by the drug's approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.
"This is good news because it tells us that the FDA is indeed treating obesity seriously," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. "On the other hand, it's not the answer to the problem - or even a big part of the answer."
Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.
"The way these things tend to work is you have some people who do extremely well and other people don't lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field," said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College.
The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.
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FDA Approves First Weight-Loss Drug In 13 Yrs.
Atkins-Type Diets: Bad for the Heart?
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Ever try the Atkins diet? Diets low in carbohydrates and high in proteins may increase the risk of heart disease, according to a new study published in the journal BMJ.
A group of European researchers led by Pagona Lagiou of the University of Athens Medical School in Greece assessed the diets of more than 43,000 Swedish women ages 30 to 49, and followed them for an average of almost 16 years. Women who consumed a diet consisting of low carbohydrate and high protein intake were at a 5 percent higher risk of cardiovascular disease later. By the end of the end of the study period, 1,270 women developed heart disease.
Consuming as little as 20 fewer grams of carbohydrates and 5 more grams of protein per day accounted for the increase, the researchers found.
The actual number of women who developed heart disease was small -- about four or five extra cases per 10,000 women per year -- but the authors said that amounted to a considerable number over time.
Data from other studies that evaluated the relationship between low-carb diets and the risk of cardiovascular disease have been mixed.
The Nurses' Health Study from 1991 found no association between a low-carbohydrate, high-protein diet and heart disease. Other more recent research, however, did find a link between these diets and a higher risk of cardiovascular disease.
But not all proteins are alike, which can make a difference in how heart-unhealthy this type of diet is.
"Low carbohydrate-high protein diets may be nutritionally acceptable if the protein is mainly of plant origin and the reduction of carbohydrates applies to simple and refined carbohydrates," the authors wrote.
One of the problems with Atkins-type diets is they are difficult to maintain, nutrition experts said. At the height of their popularity, there were also concerns that people who ate a lot of protein in the form of red meat and also ate very little fiber put themselves at risk for disease.
The goal of the once-popular diets, nutrition experts said, is short-term weight loss.
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Atkins-Type Diets: Bad for the Heart?
Harley Pasternak Blogs: Why Gimmick Diets Don't Work
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Harley Pasternak
Courtesy Harley Pasternak
Whether weight loss, toning, muscle gain, posture, or improved health, we all want it and we want it now. Sadly, the methods used by many of us don't work, and often can lead to the opposite results.
No other sphere of wellness symbolizes this more than dieting.
If I had a penny for every client who's told me of an outrageous eating plan they've tried, with amazing results in the first few days, only to eventually gain it all back and then some well ... let's just say I'd have a lot of pennies!
I thought it may be helpful to compile a list of the most absolutely useless diets ever created, for those of you out there who've suffered through one or more of these.
The HCG Diet The Idea: This plan calls for daily injections/pill/drops of the hormone HCG (found in the urine of pregnant women), and couples it with a daily caloric intake of just 500 calories!
The Truth: Such a low intake of calories is very dangerous. Just to survive with minimal to no activity, a small woman would need at least 1,000 calories to maintain health and proper body function. Users of this diet will lose dramatic amounts of weight from starving themselves, but will gain it all (and more) back when normal eating resumes.
If your doctor tries to sell you on this program, please report them to the state medical board.
The Master Cleanse or any Cleanse The Idea: Chugging maple syrup or cayenne goop or expensive juice delivery services can "cleanse" our organs, reboot our metabolism, help us grow better hair, and have stronger nails why not throw in "win the Nobel Prize" and "win the lottery?"
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Harley Pasternak Blogs: Why Gimmick Diets Don't Work
Low-carb diet burns the most calories in small study
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Diets in study
Heres a look at the three types of diets used in the new study:
A low-fat diet, which is about 20 percent of calories from fat, 60 percent from carbohydrates, 20 percent from protein. It emphasizes whole-grain products and fruits and vegetables and cuts way back on oils, nuts, fatty meats and other high-fat foods.
A low-carb diet, similar to the Atkins diet, with only 10 percent of calories from carbohydrates, 30 percent from protein, 60 percent from fat. This diet emphasizes beef, fish, chicken, eggs, cheese, some vegetables and fruits while slashing the consumption of breads, pasta, potatoes, rice, cakes, cookies and starchy vegetables.
A low-glycemic index diet, similar to a Mediterranean diet, is made up of vegetables, fruit, beans, healthy fats (olive oil, nuts) and mostly healthy grains (old-fashioned oats, brown rice). It gets about 40 percent of daily calories from carbohydrates, 40 percent from fat and 20 percent from protein.
Source: Journal of the American Medical Association
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Low-carb diet burns the most calories in small study