| Search Weight Loss Topics: |
Posted: February 23, 2012 at 1:36 pm
The number of weight loss operations has risen 12% while hospital admissions for obesity have also jumped.
In 2010/11, there were 8,087 weight loss stomach operations in England's hospitals, up from 7,214 in 2009/10, according to data from the NHS Information Centre.
The report highlights around a 30-fold increase in the number of people going under the knife in the last decade, from just 261 weight loss operations in 2000/01.
Recent figures include operations to adjust an existing gastric band rather than fit a new one. Of the 8,087 procedures in 2010/11, 1,444 were for maintenance of an existing band. Bariatric weight loss surgery includes stomach stapling, gastric bypasses and a procedure called sleeve gastrectomy.
The report also found a dramatic rise in the number of hospital admissions for patients whose main diagnosis was obesity.
Over the last decade, these admissions have risen from 1,054 in 2000/01 to 11,574 in 2010/11. Admissions among women are almost three times higher than for men - 8,654 in 2010/11 compared with 2,919 for men.
The North East has the highest rate of admissions with a primary diagnosis of obesity (40 per 100,000 of the population), followed by the East Midlands (36 per 100,000) and London (35 per 100,000). The South West, south central and North West have the lowest rates, with 14 admissions for every 100,000 people.
Weight loss surgery was most common in the East Midlands (32 procedures for every 100,000 people) and least common in the North West (six per 100,000). The figure in the east of England and south central regions was nine procedures for every 100,000 population.
Chief executive of the NHS Information Centre Tim Straughan said: "The report charts the growing impact of obesity on both people's health and NHS resources. It also examines changes in physical activity and diet. Those working in this field may want to examine closely the findings of the report, including the significant regional variations that appear to exist in both the admissions for obesity and those for weight loss stomach surgery."
A Department of Health spokesman said: "We want people to live healthier lives so they do not need to resort to surgery. We are working with charities, local government and industry to make it easier for people to make better choices. This year a third of meals and takeaways served from popular high street chains will contain calorie information and over a million families are involved in our Change4Life campaign - helping people to eat well and move more."
Read more here:
Weight loss operations up by 12%
Posted: February 23, 2012 at 1:36 pm
February 23, 2012, 8:09 AM EST
By Anna Edney
Feb. 23 (Bloomberg) -- Vivus Inc. more than doubled in early trading after the company’s weight-loss pill Qnexa won the backing of a U.S. advisory panel, moving a step closer to gaining approval as the first new obesity drug in 13 years.
Vivus gained $12.20 to $22.75 at 7:44 a.m. The shares of NeuroSearch A/S and Novo Nordisk A/S, Danish companies developing obesity treatments, also gained after advisers to the Food and Drug Administration voted 20-2 yesterday that Qnexa’s benefits outweigh its risks. The FDA isn’t required to follow the panel’s recommendation.
Qnexa is one of three medications vying for the first U.S. approval of a prescription weight-loss treatment since Swiss drugmaker Roche Holding AG’s Xenical in 1999. The FDA plans to have advisers discuss in March the possibility of requiring heart-risk studies for all weight-loss drugs. Panel members discussed whether Vivus should conduct such a study before or after approval.
“Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” said Sanjay Kaul, a cardiology professor in the David Geffen School of Medicine at UCLA Cedar Sinai Medical Center and a panel member.
The FDA is due to decide on the drug, which it rejected in 2010, by April 17.
Trading in Vivus stock was halted yesterday before the FDA panel vote. NeuroSearch, which is developing tesofensine for obesity, climbed 8.7 percent to 17.50 kroner and Novo Nordisk, which is studying its Victoza diabetes drug as a weight-loss treatment, climbed 2.6 percent to 805 kroner at 1:43 p.m. in Copenhagen.
Heart Risk Concerns
Regulators raised concerns that Qnexa may contribute to a greater risk of heart ailments and birth defects. The medicine combines the appetite suppressant phentermine with topiramate, an antiseizure and migraine drug. The Mountain View, California- based company has proposed a post-approval trial to assess Qnexa in reducing major heart complications in obese, at-risk patients. The trial would involve 11,300 patients and take four and a-half years.
Analysts say the drug, if approved, may generate $448 million in sales in 2015.
Topiramate is the active ingredient in Johnson & Johnson’s Topamax. The anticonvulsant is also associated with confusion, difficulty with concentration and memory loss.
Vivus’s analysis of heart risks for Qnexa was “somewhat reassuring,” though the significance of an observed increase in heart rate was “uncertain,” FDA staff said Feb. 17 in a report.
Obesity Risks
More than one-third of U.S. adults are obese, and another third are overweight, according to the Centers for Disease Control and Prevention. The obesity rate among adults has more than doubled since 1980 to 72 million people.
Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the Atlanta-based CDC.
Orexigen Therapeutics Inc., based in La Jolla, California, and San Diego-based Arena Pharmaceuticals Inc. also are seeking approval for their obesity medicines, which the FDA refused to approve without more data on safety risks.
Vivus examined medical claims data and found five oral clefts in a group of 1,740 children whose mothers had taken topiramate alone in the first trimester of pregnancy, for a prevalence rate of 0.29 percent, the company said Dec. 21 in a statement. That compared with a rate of 0.16 percent in the group whose mothers had taken antiseizure drugs, including topiramate, before pregnancy.
Study Results
Vivus plans to finish the results in the third quarter of this year, after the April 17 deadline for the FDA to decide whether to approve the drug. The risk of oral clefts hasn’t been fully answered by the interim data, FDA staff said.
The FDA asked Vivus in January to remove wording from Qnexa’s proposed prescribing label advising women with the potential to become pregnant against taking it. The FDA staff said in the Feb. 17 report severely restricting Qnexa isn’t practical because topiramate also treats other serious conditions.
Panel members, meeting yesterday at FDA headquarters in Silver Spring, Maryland, suggested the agency should consider restricting topiramate used for seizures and migraines for women of childbearing age.
“I just can’t get my mind around why it would be different,” said Lamont Weide, chief of diabetes and endocrinology at the Truman Medical Centers Diabetes Center in Kansas City and a member of the panel.
Restricting Distribution
Russell Katz, director of FDA’s neurology products division, said the agency hasn’t considered restricting the drug because there aren’t many options for migraine prevention.
Vivus has suggested restricting distribution of Qnexa to less than 10 large mail-order pharmacies with pharmacists trained in dispensing the drug, Barbara Troupin, senior director of global medical affairs at the company, said.
In addition to Roche’s Xenical, London-based GlaxoSmithKline Plc’s Alli, a half-dose version of Xenical’s active ingredient, won FDA clearance in 2007 as the first diet drug available without a prescription.
--With assistance from Makiko Kitamura in London and Frances Schwartzkopff in Copenhagen. Editor: Phil Serafino, Bruce Rule
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net
Read the original:
Vivus Weight-Loss Pill Qnexa Wins Backing of FDA Panel
Posted: February 23, 2012 at 1:35 pm
The most important weight-loss message - you have to use more calories than you eat - hasn't changed in decades.
But dieting experts say science has some new, surprising things to say about the other half of the standard recommendation - exercise - and about which diet to use.
Researchers are also refining the behavioral tricks that can change the way people eat, not only to lose weight but also to keep it off. Modern technology is giving dieters new options, such as Internet- and cell-phone-based programs or scales that can transmit your weight from your home to your doctor or dietitian.
Thomas Wadden, director of the Center for Weight and Eating Disorders at the University of Pennsylvania, said the last decade has seen "pretty aggressive diet wars" among the proponents of low-fat, low-carb, or low-glycemic-index approaches.
After years of comparisons, Wadden and other experts said the verdict is clear: What you choose doesn't matter. Pick a diet you can stick to, including liquid diets or prepared meals. If you follow the rules, the results are all about the same. Wadden said he does recommend that, whatever the diet, patients reduce saturated fats and trans-fats for better health. You can pick a more aggressive approach while you're losing, eventually transitioning to a diet rich in vegetables, fruits, and lean protein for maintenance.
Gary Foster, director of Temple University's Center for Obesity Research, thinks diet gurus have scared people off with too much information. "We tell people so much stuff, it's paralyzing," he said.
He agreed that the specific diet doesn't matter. "Calories drive weight loss," he said.
To lose a pound a week, a dieter needs to eat 500 fewer calories a day. That's simple enough, but your maintenance needs come down as people get smaller. That explains why weight loss gets harder as you go. Think of your body as a house. It takes more energy to heat a big house than a small one. A woman who weighs 300 pounds maintains her weight on about 3,000 calories. (Because they have more muscle, men use a few more.) A woman who weighs 140 needs only 2,050 calories to stay there. Caloric needs drop further as we age and lose muscle mass.
Cheryl Marco, a registered dietitian who runs Thomas Jefferson University's weight management program, starts patients on a prepackaged diet that includes shakes and bars. Dieters have few options.
"Fewer choices work better," Marco said. "What works is the narrowing of stimuli." So her most successful long-term dieters eat meals that don't vary much from day to day.
Some people may just have to stay away from foods that trigger overeating.
"I am not of the belief . . . that we have the ability to learn to eat high-risk foods in moderation," Marco said. Your high-risk food may be ice cream. Someone else's may be fettuccine Alfredo.
John McAroy, 38, dropped 70 pounds (from 300 on a 6-foot-2 frame) between Thanksgiving and early February using Marco's method. He hasn't cheated much and hasn't missed having more choices. "You'd be surprised," he said. "I'm rarely hungry."
So what about exercise? Isn't it the answer?
No, the experts said.
Exercise is "the single best predictor of who keeps weight off and who doesn't," Foster said. "It has very little effect on weight loss."
Exercise can help people lose weight, but so slowly that most people lose interest, he said. It's easier for most people to cut 500 calories out of their diet a day than to burn an extra 500 calories. You have to walk five miles to do that.
What exercise does do is help people maintain muscle mass, which revs up metabolism a little and improves overall health. Still, adding five pounds of muscle takes a lot of work, and a pound of muscle burns only about 15 calories a day.
In one of the cruel twists of our evolutionary history - the one that shaped our bodies to withstand famine, not a world full of junk food - people who have lost a lot of weight burn fewer calories during exercise than people who have never dieted. "It's as if your body's gone green on you," Wadden said. To keep weight off, dieters need to exercise 225 to 300 minutes a week: about 32 to 43 minutes a day.
Foster's group is looking at whether getting a good night's sleep affects weight loss. People who weigh more tend to sleep less, but it's not yet known whether sleeping more helps people lose weight.
On the behavioral front, researchers say that "accountability" is a crucial factor in making diets work. People do best when they keep track of what they eat and how much they exercise. They need to weigh themselves frequently, ideally every day. It also helps a lot to report what they're doing to someone else. The gold standard is a face-to-face meeting, but results also improve with telephone and Internet reporting.
"It's really important to be accountable to somebody else," Foster said.
It's also important to act quickly when the numbers on the scale start moving up. Experts recommend having an action plan when weight rises by two to four pounds - perhaps returning to more intensive monitoring of food intake - and when dieters fall off the wagon.
"One of the major differences between the average-weight person and the overweight person is the ability to recover from overeating," Marco said.
Wadden says technology is offering new alternatives to people who need to lose weight. While not yet in wide use for weight control, scales that transmit weights to doctors or diet programs can build in accountability. Internet- and phone-based programs make it easier to calculate calories and energy usage.
Continued here:
New science can help guide diets and exercise
Posted: February 23, 2012 at 1:35 pm
The View
Star Jones returned to The View Wednesday, almost six years after she left the show under unpleasant circumstances.
"It was ugly, everything around was ugly," Jones, 49, observed. "It was a bad, emotional time. Nasty things were being said in the media. It was just not a good emotional time." Jones, who was on the show to promote women's heart health, seemed surprised by Walters' line of questioning about her controversial exit. "I had eight fantastic years here. One was 'eh,'" she said. "I came back to congratulate you on all you accomplished. I hope you congratulate me on what I accomplished."
Check out photos from The View
In 2006, View creator and co-host Barbara Walters revealed to Jones that her contract would not be renewed for a 10th season, and said Jones could say that it was her decision. Jones then announced on the show that she would be leaving, but told People magazine that she felt like she was "fired." The following day, Walters informed viewers that Jones would no longer be a part of the show effective immediately, and her name was quickly removed from the show's credits and from its official website.
"I take real responsibility for my own behavior at all times, but I won't take responsibility if have not made a decision I can live with. I made the decision to go out on my own terms," Jones said. "I wanted to be able to control it so when I walk back in here, if I were ever invited, I would feel good about coming in."
Watch more videos from The View
Walters and Joy Behar also asked Jones about her 2003 gastric bypass surgery. At the time, Jones refused to confirm she had undergone the procedure, despite her subsequent 160 pound weight loss. "We tried to protect you. We were told, 'Don't say it was gastric [bypass]. Say it was pilates and portion control,' " Behar said. "You are now a skinny b---. Congratulations."
Added Walters: "We did lie for you!"
Watch the full semi-awkward exchange below:
What do you think of Jones' reason for leaving? Do you miss seeing her on The View?
See the rest here:
VIDEO: Star Jones Returns to The View, Faces Questions About Controversial Exit, Weight Loss
Posted: February 23, 2012 at 1:35 pm
On Thursday, the Fast Money traders are expecting a big move from this stock. Is it on your radar?
Specifically, the pros are watching Vivus
[VVUS Loading... () ] after the company received a favorable ruling on its weight loss drug Qnexa. Back in 2010, the FDA rejected Qnexa because of safety concerns.
As bullish as that catalyst is – pro trader Guy Adami sees another reason for the stock to surge.
“There’s something like 20% short interest in Vivus,” he explains. “Expect the shorts to get squeezed. As a result the jump in this stock may be larger than anticipated."
And that’s where the trading opportunity comes in – but you have to be nimble. The Fast traders thinks the stock could overshoot to the upside.
“The stock could over pop early and then have a really big pullback,” says Pete Najarian. In other words if there's an extreme move trade accordingly.
Qnexa, which combines the appetite suppressant phentermine and anti-seizure drug topiramate, helped patients lose at least 10 percent of their weight after a year of treatment, the company said.
The FDA has not approved a new obesity drug since 1999.
Current DateTime: 04:40:11 23 Feb 2012
LinksList Documentid: 26256943
Current DateTime: 04:40:11 23 Feb 2012
LinksList Documentid: 26256941
______________________________________________________
Got something to to say? Send us an e-mail at and your comment might be posted on the Rapid Recap. If you'd prefer to make a comment, but not have it published on our Web site, send those e-mails to
Trader disclosure: On Feb 22, 2012, the following stocks and commodities mentioned or intended to be mentioned on CNBC’s "Fast Money" were owned by the "Fast Money" traders; Najarian is long AAPL; Najarian is long C; Najarian is long YHOO; Najarian is long HPQ; Najarian is long MOS; Najarian is long SCCO; Najarian is long COP; Najarian is long PFE; Najarian is long MRK; Adami is long C; Adami is long GS; Adami is long INTC; Adami is long MSFT; Adami is long NUE; Adami is long BTU; Adami is long AGU
For Ron Insana
No disclosures
For Mike Khouw
No disclosures
For Doug Kass
Kass is short SPY common and calls
Kass is short QQQ
Kass is short IWM
Kass is short EFA
For Amelia Bourdeau
No disclosures
CNBC.com with wires.
© 2012 CNBC.com
Posted: February 22, 2012 at 11:12 pm
16-02-2012 16:28 TayTay's 100lb Weight Loss Journey weigh in 20 and 21.
Here is the original post:
TayTay's 100lb Weight Loss Journey weigh in 20
Posted: February 22, 2012 at 11:12 pm
10-02-2012 23:15 WEIGHT LOSS TRANSFORMATIONS: WHY HIGH CARB LOW FAT WORKS Dietary thermogensis is the reason why 1000% of LONGTERM high carb low fat munchers are slim beans. Low carb HIGH FAT = High body fat and bad arteries. Hence why the majority of paleo, primal diet, low carb diet promoters have excess weight issues unless they are using steroids like is common in that scene unfortunately. Raw food diet vegan high carb low fat style based on fruit keeps you slim naturally. How to get a flat stomach, how to lose weight fast, how to lose weight with raw foods.how to start a raw food diet? all these questions and more answered by Durianrider and Freelee on our channels. Thanks for watching! 🙂 Durianrider on Facebook http://www.facebook.com To Donate to Durianrider: http://www.paypal.com Durianriders 2$ audio mp3 and blog links below. ?www.30bananasaday.com Blog ?www.durianrider.org? TAGS goal weight dream goal weight loss journey losing the fat weight watchers watch me shrink weight loss losing weight slim down baby fat shrinking calorie burning exercise calorie counting health and fitness diet and exercise diet and fitness diet bathing suit swimsuit before and after vegetarian raw food vegan durianrider freelea freelee
Go here to see the original:
WEIGHT LOSS TRANSFORMATIONS: WHY HIGH CARB LOW FAT WORKS - Video
Posted: February 22, 2012 at 11:11 pm
SILVER SPRING, Md. — A panel of advisers to the Food and Drug Administration overwhelmingly backed approval for a highly anticipated anti-obesity pill called Qnexa, a drug which the FDA previously rejected due to safety concerns.
Don't miss these Health stories
Gluten-free diet may be a waste of money for some
Gluten-free products are everywhere, but many people who buy them are probably wasting their money, according to new Italian research.
Teens need less sleep? 7 hours may be enough Hospitals scramble for scarce kids' cancer drug Arsenic found in organic cereal bars Amid shortages, hospitals trash scarce drugs
The FDA panel of outside physicians voted 20-2 Wednesday in favor of the weight loss drug from Vivus Inc., setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.
A majority of panelists ultimately backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.
"The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell," said Dr. Kenneth Burman of the Washington Hospital Center.
The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected in April.
In a key question, the physicians said Vivus could conduct its study after FDA approval. Conducting the study ahead of market approval would cost the company millions of dollars and take at least three more years.
"There is an urgent need for better pharmacologic options for individual patients with obesity," said Dr. Elaine Morrato, of the University of Colorado. "I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."
Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.
The FDA rejected the diet pill Qnexa in October 2010, citing numerous side effects including raised heart rate, psychiatric problems and birth defects. Vivus has resubmitted the drug with additional follow-up information on safety, hoping for a more favorable ruling.
Vivus President Peter Tam said the overwhelming panel vote Wednesday underscores the need for effective weight loss drugs.
"I think they see the medical need," Tam said. "Right now there aren't any good treatments out there besides dieting and bariatric surgery, clearly there's a huge gap."
With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. Analysts expect a new weight loss pill to garner at least 10 million users within a few years.
Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an antiseizure and antimigraine drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.
Along with heart safety, panelists raised concerns about potential birth defects in women who become pregnant while taking Qnexa. One of the two ingredients in the combination pill, topiramate, is known to more than double the risk of birth defects.
There were 34 pregnancies among 3,386 women enrolled in Vivus' studies of Qnexa, despite precautions to make sure women used contraception. An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa.
If approved, FDA scientists said they would require Vivus to train prescribers in the pregnancy risks of Qnexa and distribute warning pamphlets to patients. The drug would only be available from 10 mail-order pharmacies. An experimental obesity drug from Vivus Inc won a U.S. panel's support on Wednesday, raising hopes regulators would approve a weight-loss pill for the first time in 13 years.
A panel of outside experts to the Food and Drug Administration voted 20-2 to recommend approval of Qnexa, meant to treat obesity and its accompanying health problems.
The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected by April 17.
© 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Excerpt from:
FDA panel backs weight loss drug Qnexa
Posted: February 22, 2012 at 11:11 pm
By Anna Edney - Wed Feb 22 22:13:35 GMT 2012
Vivus Inc. (VVUS)’s weight-loss pill Qnexa won the backing of a U.S. advisory panel as the company seeks to gain approval for the first new obesity drug in 13 years.
Advisers to the Food and Drug Administration voted 20-2 today that Qnexa’s benefits outweigh its risks at a meeting at agency headquarters in Silver Spring, Maryland. The FDA isn’t required to follow the panel’s recommendation. The agency is scheduled to make a decision on the drug, which it rejected in 2010, by April 17.
Qnexa is one of three medications vying for the first U.S. approval of a prescription weight-loss treatment since Swiss drugmaker Roche Holding AG (ROG)’s Xenical in 1999. The FDA plans to have advisers discuss in March the possibility of requiring heart-risk studies for all weight-loss drugs. Panel members discussed whether Vivus should conduct such a study before or after approval.
“Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” said Sanjay Kaul, a cardiology professor in the David Geffen School of Medicine at UCLA Cedar Sinai Medical Center and a panel member.
Regulators raised concerns that Qnexa may contribute to a greater risk of heart ailments and birth defects. The medicine combines the appetite suppressant phentermine with topiramate, an antiseizure and migraine drug. The Mountain View, California- based company has proposed a post-approval trial to assess Qnexa in reducing major heart complications in obese, at-risk patients. The trial would involve 11,300 patients and take four and a-half years.
Sales Potential
Analysts say the drug, if approved, may generate $448 million in sales in 2015.
Topiramate is the active ingredient in Johnson & Johnson (JNJ)’s Topamax. The anticonvulsant is also associated with confusion, difficulty with concentration and memory loss.
Vivus’ analysis of heart risks for Qnexa was “somewhat reassuring,” though the significance of an observed increase in heart rate was “uncertain,” FDA staff said Feb. 17 in a report.
More than one-third of U.S. adults are obese, and another third are overweight, according to the Centers for Disease Control and Prevention. The obesity rate among adults has more than doubled since 1980 to 72 million people.
Obesity Risks
Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the Atlanta-based CDC.
Orexigen Therapeutics Inc. (OREX), based in La Jolla, California, and San Diego-based Arena Pharmaceuticals Inc. (ARNA) also are seeking approval for their obesity medicines, which the FDA refused to approve without more data on safety risks.
Vivus examined medical claims data and found five oral clefts in a group of 1,740 children whose mothers had taken topiramate alone in the first trimester of pregnancy, for a prevalence rate of 0.29 percent, the company said Dec. 21 in a statement. That compared with a rate of 0.16 percent in the group whose mothers had taken antiseizure drugs, including topiramate, before pregnancy.
Vivus plans to finish the results in the third quarter of this year, after the April 17 deadline for the FDA to decide whether to approve the drug. The risk of oral clefts hasn’t been fully answered by the interim data, FDA staff said.
Topiramate Effects
The FDA asked Vivus in January to remove wording from Qnexa’s proposed prescribing label advising women with the potential to become pregnant against taking it. The FDA staff said in the Feb. 17 report severely restricting Qnexa isn’t practical because topiramate also treats other serious conditions.
Panel members suggested the FDA should consider restricting topiramate used for seizures and migraines for women of childbearing age.
“I just can’t get my mind around why it would be different,” said Lamont Weide, chief of diabetes and endocrinology at the Truman Medical Centers Diabetes Center in Kansas City and a member of the panel.
Russell Katz, director of FDA’s neurology products division, said the agency hasn’t considered restricting the drug because there aren’t many options for migraine prevention.
Vivus has suggested restricting distribution of Qnexa to less than 10 large mail-order pharmacies with pharmacists trained in dispensing the drug, Barbara Troupin, senior director of global medical affairs at the company, said.
In addition to Roche’s Xenical, London-based GlaxoSmithKline Plc (GSK)’s Alli, a half-dose version of Xenical’s active ingredient, won FDA clearance in 2007 as the first diet drug available without a prescription.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net
See the original post:
Vivus Weight-Loss Pill Qnexa Wins Backing of FDA Advisory Panel
Posted: February 22, 2012 at 11:11 pm
WEDNESDAY, Feb. 22 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel gave its endorsement Wednesday to a highly anticipated weight-loss pill that had been rejected by the health advisers once before.
The committee of outside physicians voted 20-2 to back the drug Qnexa, although the group urged that patients be monitored closely for potential heart problems, the Associated Press reported.
A decision by the full FDA is expected in April. The agency typically follows the recommendations of its advisory panels.
While effective at reducing weight, the drug, manufactured by Vivus Inc., was denied approval in 2010 because of its potential side effects. Before making its decision Wednesday, the advisory panel reviewed two years of data on the drug; when advisers last voted on Qnexa, only one year's worth of follow-up data was available.
The drug combines the appetite suppressant phentermine and the anti-seizure/migraine drug topiramate. Phentermine was once widely prescribed as the "phen" part of the fen-phen weight loss drug. This combo was withdrawn from the market after its use was linked to high blood pressure in the lungs and heart valve disease. The problems were related to the "fen" or fenfluramine part of the combination, not the phentermine.
No new weight-loss drug has been approved in the United States in the past 13 years, according to published reports. As it stands, Xenical is the only FDA-approved drug specifically for long-term use -- up to a year -- for weight loss. Xenical is sold over-the-counter as Alli. However, other drugs may be used off label to promote weight loss.
Last April, a study funded by Vivus found that obese patients taking Qnexa lost an average 22 pounds over a year, while also lowering their blood pressure and cholesterol levels.
Dr. Louis Aronne, founder and director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City, was cautiously optimistic that Vivus did a good job responding to FDA safety concerns, and that the FDA will give the drug its nod of approval, with some caveats. Aronne was not involved in the trials but has been an adviser to Vivus and other companies developing weight loss medications.
"I am not as pessimistic as most people," he said.
Vivus has reported that Qnexa may increase the risk of cleft lip in babies of women who use the drug while pregnant. Aronne said the birth defect concern could be addressed through education on who should and should not use the new drug.
"We have learned our lessons with weight loss drugs," he said. "They need to be used in the right people under the right circumstances." The heart risks need to be weighed against reductions in heart disease risk factors that come with weight loss, he said.
Qnexa is not any riskier than bariatric surgery, according to Aronne. "The problem is that it can be distributed more widely," he said. He hopes for a compromise that allows the new compound to be prescribed, but not misused. "Once new medications are approved, local medical boards will need to enforce rules and make sure these medications are prescribed appropriately to the right candidates," he said. "We don't want to open up pill mills."
One thing is clear, he said: More options to treat obesity are needed. "For hypertension, there are 120 medications in nine categories," Aronne said. "We need new options and we need to get physicians thinking about obesity and obesity treatments."
Dr. Scott Kahan, an obesity expert at Johns Hopkins University in Baltimore and director of the National Center for Weight and Wellness in Washington, D.C., agreed. He is optimistic about the FDA's upcoming decision on Qnexa. "The weight loss effects are striking and approaching the amount of weight loss over two years that we get with bariatric surgery," he said. "This is really impressive."
More information
Learn more about weight loss medications at the U.S. National Institutes of Health.
See the article here:
FDA Advisers Back Weight-Loss Drug Qnexa
