Obesity Discussion Forums

[Obesity Discussion]

FDA Approves Non-Prescription Diet Pill
Wednesday February 7, 6:49 PM EST


WASHINGTON (AP) — Dieters got a new tool Wednesday to help them take off the extra pounds — the first government-approved nonprescription diet pill. The Food and Drug Administration said the fat-blocking weight-loss pill orlistat, which has been available by prescription, can be sold in a reduced-strength version over the counter.
The new version will be sold as "alli" by GlaxoSmithKline PLC. Xenical, the prescription version, is made by Roche Holding AG.
The drug is intended for people 18 and older to use along with a reduced-calorie, low-fat diet and exercise.
Dr. Charles Ganley, FDA's director of nonprescription products, stressed that the drug is intended for use along with diet and exercise programs.
"Using this drug alone is unlikely to be beneficial," Ganley said at a telebriefing.

While some dietary supplements make weight-loss claims, Ganley said this is the first nonprescription drug approved by the agency for that purpose.
Ganley said in trials, for every five pounds people lost through diet and exercise, those using orlistat lost an additional two to three pounds.
When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat — about 150 to 200 calories worth — is passed out of the body in stools, which can be loose as a result. About half of patients in trials experienced gastrointestinal side effects.
The agency recommended users take a multivitamin when using this drug.
The new drug would contain half the dose of Xenical prescription capsules. The price has not been set but is expected to run $1 to $2 a day, company officials said. The company estimated 5 million to 6 million Americans a year would buy the drug over the counter.
The Food and Drug Administration said the most common side effect of the product is a change in bowel habits including loose stool and some oily spotting. Eating a low-fat diet will reduce the likelihood of this side effect.
FDA said people who have had organ transplants should not take OTC orlistat because of possible drug interactions. In addition, anyone taking blood-thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat, the agency said.
GSK Consumer Healthcare, which will market the pill, said it chose the name alli to indicate a partnership with consumers in their weight-loss efforts.
"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes," said Dr. Douglas Throckmorton, deputy director for the FDA's Center for Drug Evaluation and Research.
"OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health," he said. But Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, called the approval "the height of recklessness." Wolfe said studies have associated the prescription version of the drug with precancerous lesions of the colon. He has also called for withdrawal of the prescription version.

Diet Pill

[Irving]

if this pill is legit I fathom they will sell a lot more than they think :yup:

[William Wallace]

Originally Posted by Irving

if this pill is legit I fathom they will sell a lot more than they think :yep:

I agree, I think this could be huge!

I saw on the news that for every 5 lbs someone would normally lose due to diet and exercise, this pill will allow them to lose an extra 2-3lbs on top of that.

The only negative is that half the people taking this reported much softer stools, which is a much more polite way of saying they had Diarrhea

[Obesity Discussion]

Here is an interesting counter opinion so to speak......




Experts say over-the-counter diet drug is no silver bullet
by Kris Wise



Doctors and diet experts are warning that an over-the-counter diet drug just approved by the federal government could be a distraction for West Virginians striving to change the state’s obesity rate one pound at a time.
The U.S. Food and Drug Administration just this week put its seal on Orlistat, a reduced-strength version of the popular prescription weight-loss drug Xenical.
It’s the first time the federal agency has approved an over-the-counter drug to help people lose weight.
When the pill makes its debut on store shelves, the name on its packaging will be “Alli.” It’s expected to cost $1 to $2 for one day’s dose.
Echoing a warning by federal officials, some local weight loss experts said the product should not be used as a stand-alone approach to taking off pounds.
“One thing a lot of the public is going to get into trouble with is thinking it’s the panacea,” said Dr. Robert Shin, director of the Weight Loss Center at Charleston Area Medical Center.
“When you look at the studies, for people who do not change eating behaviors, who don’t develop healthy habits and get more active, the drug is not as effective.”
Dr. Kathleen Mimnagh, director of the hospitalist program at Charleston Area Medical Center, has helped at least one local elementary school — her daughter’s — develop programs aimed at improving student eating habits.
She said an easily accessible product like Alli could divert attention from long-term answers to society’s problem of obesity.
“It’s a good adjunct, but it’s only part of the solution,” Mimnagh said of the over-the-counter pill. “There’s a much bigger picture to look at.
“I’m not a believer in this quick fix,” she said. “I think we should be targeting a lot of other facets of the problem, from our fast-food restaurants to designing cities and towns that encourage activity to trying to use the vehicle of schools to shape better eating habits.”
The state already is struggling with how to reshape many residents’ skewed perspectives on nutrition and exercise.
West Virginia right now has one of the highest obesity rates in the nation.
The long-term effects of the problem — including increased rates of diabetes and heart disease — have caused the state’s insurance and medical costs to skyrocket.
Even as long as five years ago, the state’s Medicaid program estimated it spent as much as $140 million annually on obesity-related medical and prescription expenses.
In an effort to cut those costs, Medicaid has begun a new reward system that encourages people to eat better and exercise more.
Now, about 75,000 of the state’s poor and elderly who receive Medicaid benefits also will be able to enroll in the Weight Watchers program for free, thanks to recent changes in the system.
The West Virginia Healthy Lifestyle Coalition, created in 2003 and funded by a nonprofit group grant, also works to promote changes in eating and exercise habits, specifically in early childhood, to prevent people from becoming overweight in the first place.
“I guess people are always looking for that silver bullet, but our efforts still are going to focus on educating people about portion sizes, smart nutrition and physical activity,” coalition director Helen Matheny said Thursday. “We really aren’t going to get into the medication aspect of it.”
Alli, pronounced ‘Al-eye” and named to evoke the idea that the pill will be a dieter’s ally, works by blocking the absorption of a portion of fat in food eaten by a person. Up to 200 calories a day can be cut as some fat is sent straight through the intestinal tract.
Medical professionals and government officials acknowledge the pill can have some side affects, namely gastrointestinal pain and diarrhea.
Shin, at the CAMC Weight Loss Center, said the center does recommend the prescription-only Xenical — the precursor to the over-the-counter drug — for some overweight patients.
But it’s only one part of a multi-dimensional approach to getting healthy.
“We don’t prescribe it right away,” Shin said. “When you look at all the criteria, you have to change behaviors first and then medications or surgeries can help you on top of that.”
Studies show that in most cases, a drug such as Alli might add up to a 10 percent weight loss if combined with proper diet and exercise.
Shin said some patients who have taken the stronger, prescription version of the drug have complained about the gastrointestinal side effects.
The most common complaint is about severe gas, he said.
Shin urges people to find out as much as they can about how the drug works, and when it might be most effective.
He said people who get too many calories from sugars or carbohydrates might not benefit as much as others because, again, the pill reduces just the absorption of fat in the body.
“It could help when you go out and eat a big, fatty meal,” Shin said. “But if they eat too much carbohydrates, they aren’t going to lose weight just because they take this pill.”
Mimnagh said she worries that increased availability of the drug will send the wrong message to young people who should be learning early lessons about healthy living and moderation. “It takes a village to change this, and it’s more than just a diet pill,” Mimnagh said. “The patients all seem to want a quick fix, but is this just going to let them continue eating unhealthy foods? These are questions we have to answer.”

Diet Pill

[Obesity Discussion]

Per Sanjay Gupta, CNN's chief medical correspondent, he lists a few things people should know about Alli:


Dr. Gupta: Things to know before taking alli

POSTED: 1:08 p.m. EST, February 8, 2007


By Dr. Sanjay Gupta
CNN Chief Medical Correspondent

(CNN) -- A fat-blocking weight-loss pill called alli is the first diet drug to be approved by the FDA for over-the-counter sales. It's a reduced-strength version of the prescription medication Xenical. Here's what I think you should keep in mind before considering this drug:
1) Diet and exercise are still going to be your longest-lasting weight-loss solution.
2) The manufacturers of alli and the FDA emphasize that this medication cannot work alone. It must be combined with low-fat diet and multivitamin taken at bedtime.
3) There are side effects, and they are not pleasant. Since the medication works by blocking fat from being absorbed in your intestines, patients may experience diarrhea, bloating and cramping.
4) Eating a low-fat diet, while on this medication will reduce side effects. And, of course, eating a high-fat diet will increase the unpleasant gastrointestinal side effects.
5) This is not a miracle drug. You will still have to work for the weight loss.
6) While the prescription version, Xenical, is approved for anyone 12 and older, the over-the-counter version is intended only for adults 18 and older.
7) If adolescents are taking the medication, they should continue to do so only under a doctor's supervision.
8) If you have had an organ transplant, you should not take this medication because of possible drug interactions with cyclosporine, an anti-rejection medication.
9) If you are diabetic, have a thyroid condition or are on blood thinners, talk to your doctor before starting this medication.
10) And the big question: How much will you lose? Expect modest weight loss. If you lose 5 pounds through diet and exercise, the FDA says you can expect to lose 2 to 3 more pounds by taking this pill. By the way, the weight loss plateaus after six months.

Diet Pill