Alli slimming pill safety under question

A new over-the-counter weight-loss drug called Alli may give people with eating disorders another tool to harm themselves, therapists fear.

Alli — pronounced “AL-eye” — is the only weight-loss medicine on the market approved by the federal Food and Drug Administration. It’s half the dose of the prescription drug orlistat, trade name Xenical, which is used to fight morbid obesity.

Dr. Randall Flanery, head of the Eating Disorders Program for the St. Louis Behavioral Medicine Institute, said the new drug is ripe for abuse because young people with eating disorders find the side effects of intense diarrhea and other gastrointestinal problems that empty the digestive system inviting.

People who use diet products to bolster their eating disorders “tend to take them at much higher dosages than recommended, as much as 10 times,” Flanery said. “It’s analogous to laxatives. People with eating disorders take 10 to 50 (laxative pills) at a time. They become dependent and take higher and higher dosages.”

Another danger is that the medicine is approved by the FDA “and people will believe that because it’s over-the-counter and FDA-approved, it must be safe,” Flanery said. “It’s not.”
The drug should be kept behind counters and monitored for distribution to make sure that at least teens don’t have access to it, Flanery said.

What is it?

The FDA approved Xenical nearly 10 years ago. It limits the absorption of fat so that the fat doesn’t enter the bloodstream as triglycerides. Triglycerides are used for fuel and are stored in fat cells. In excess, they clog the blood vessels and help cause heart attack, stroke and organ failure. They can elevate because you eat too much fat or because you have a disease such as diabetes.

The FDA approved Alli in February at 60 milligrams. (prescription-strength Xenical is sold in 120 mg capsules.) The manufacturer, GlaxoSmithKline, said in its advertising literature that the drug can increase weight loss by 50 percent if it’s used along with a reduction of fat intake and an increase in exercise.

But you can experience oily diarrhea, flatulence and other intestinal side effects.

Not unanimous

A weight-loss specialist said anything Alli can do can be done for a tiny fraction of the cost by medications that are easier to purchase by minors.

“There are a lot of cheaper ways to get diarrhea,” said Dr. Samuel Klein, head of the Weight Management Program at Washington University in
St. Louis. “This medication is $60.” That’s for 90 pills.

“It’s half the dosage (of the prescription version), and the manufacturer is marketing it responsibly as something that needs a change in lifestyle to work,” Klein said.

Also, he said, the gastrointestinal problems are bothersome enough that even someone with an eating disorder wouldn’t want to face them, especially with easier alternatives.

Eating disorders

Flanery’s concern is that people with anorexia nervosa and bulimia — about 1 percent of the female population younger than 24 and a growing number of men — use a bunch of tricks to get thinner.

The tricks include faking eating, taking laxatives, purging (vomiting a meal), isolating themselves and taking amphetamines to reduce appetites.

Debbi Kuehnel, a counselor and owner of the Eating Disorder Recovery Center, wants the drug to be taken off the market. People with eating disorders are as prone to trends as anyone, and Alli’s newness could be its attraction, she said.

“We already had a client who stole a bottle,” Kuehnel said. “She took 10 pills. They don’t care about the side effects.

“Putting this drug on the market was ridiculous,” she continued. “The ads say eat right, exercise and change your lifestyle and use the drug. You’ll lose weight if you eat right, exercise and change your lifestyle; you don’t need the drug.

“The prescription dose was meant for people who are morbidly obese; there’s no need to make it over-the-counter.”

Via http://www.holmencourier.com/articles/2007/08/23/news/drug.txt

Best weight loss pills

Slimming pills – Alli and Proactol

Question: I have heard a lot about a new over-the-counter slimming pill. Is it safe and how do I know if I am a good candidate?

Answer: The new drug on the market is Alli. It is the first over-the-counter slimming pill that has been approved by the Food and Drug Administration.

Other slimming drugs or supplements fall into a category that is not tested by the FDA. Such supplements are not allowed to claim that they cure or prevent disease and if the claims made do seem promising then the FDA does not back it up.

However, this new drug has been tested. I still warn you to be cautious since many drugs have side effects and interactions that are not found until the drug has been used for some time. The fact that the FDA has approved its proper use is helpful in determining a level of safety and efficacy.

The drug, Alli, claims to help you lose 50 percent more weight than what you would lose on just exercise and diet alone. It is not suggested for use by those who need to lose only a few pounds. Alli is a drug that blocks the absorption of fat by the body. This can lessen the amount of calories that your body absorbs and thus, helps you lose weight.

It works as an enzyme that attaches to the fat molecules that enter your body. It blocks about a quarter of the amount of fat absorbed as calories.

What isn't absorbed is carried out of the body. Therefore, if you eat too much fat in your diet, the excess fat can leave your body in a not-too-pleasant way.

There are side effects to this weight-loss plan. These are some of the side effects: Gas with oily spotting, loose stools and more frequent stools that may be hard to control.

Those effects may not be worth the added weight loss. So I highly recommend that you try a reduced-calorie diet and a healthy dose of exercise first. The Alli slimming plan includes daily pills as well as tailored eating plan found on the Web site.
Once you purchase the package, you will be able to register for myalliplan for free. You can also take a quick quiz on the Web site to see if you are a good candidate.

General questions are if you are: willing to try to lose weight gradually, committed to eating a low-calorie, low-fat diet (15 grams or less a day), committed to eating smaller portions, understand the possible side effects, make more time to be physically active and if you will read the label and follow directions properly. It is also recommended that you only do this program if you have significant weight to lose.

As with any slimming program, you should consult with your physician before starting.
There are other fat blocking supplements and pills, including Orlistat, that you have to get through a prescription, and chitosan, which is derived from shellfish. Do your research and remember that many slimming supplements are not tested by the FDA and have a greater risk for side effects and improper ingredients.

Another thing to consider is the cost. You can take up to three capsules a day and the starter pack contains 90 capsules. The starter pack costs roughly $60 and the refill container contains 60 capsules at about $50. That between $2 and $2.50 a day.
If you decide to try this plan, then make sure you change your lifestyle habits so that when you quit the program, you can maintain your weight loss and control the things that got you where you are.

Important to notice that among natural slimming pills Proactol fat binder is alternative fat blocker that blocks 27% of your fat effectively. Proactol is not FDA approved slimming pill but it is clinically tested (including double-blind placebo studies) and approved by MHRA as medical device for weight management.



Proactol is the only credible natural alternative to Alli that is available now without side effects. You can get all the necessary information on Proactol site. Generally Proactol offered along with special weight loss program, including healthy low fat recipes, exercising demonstration videos and toning belt as free bonus.

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It is imperative that you find ways to change lifestyle habits and if a program like this can help you lower your calories and fat intake, then it is helping you gain some control and balance. Make sure that the program leads you be to a healthier person inside and out.

What about Alli side effects?

How badly do you want to be skinny? Is it worth soiling your underwear?

Those questions will likely confront users of the new Alli, the first over-the-counter slimming pill approved by the U.S. Food and Drug Administration.

Its marketing effort makes an impression by telling users to wear dark pants and carry extra clothes in case they soil themselves.

"Well, that sounds attractive, doesn't it?" Jay Leno cracked June 25 on "The Tonight Show." "You lost a couple of pounds, and you're on a date with that special girl. 'Excuse me while I change my pants. "

NBC's Conan O'Brien also spoke up to pooh-pooh Alli, suggesting that "the drug comes in three forms: pills, capsules and chimichangas."

The slimming pill's backers say that the embarrassment is exaggerated and that the effects can be managed by a low-fat diet.

Only half of all users had "fecal urgency" or related effects in clinical trials, and just 5 percent quit for those reasons, said Vidhu Bansal, director of medical affairs for GlaxoSmithKline's consumer health division.

"They actually served as a positive feedback tool," she said. "It reminded them that they cheated on their diet."

Caroline Apovian, a Boston physician who wrote "The Alli Diet Plan," which shows how to minimize problems by eating low-fat foods, said she did not understand the shame people might feel over losing bowel control. "It's also embarrassing to be obese," said Apovian, who was a paid consultant to GlaxoSmithKline in getting Alli approved for over-the-counter sales. "It's embarrassing to be dead."

GlaxoSmithKline executives are pitching Alli as part of a lifestyle change, which includes a commitment to eat better and exercise more. Users can log in their progress on the slimming pill's Web site www.myalli.com and interact with other customers or ask questions of a pharmacist, a nutritionist, a chef and a fitness specialist.

The firm, with a U.S. headquarters in Philadelphia, paid $100 million to Xenical's maker, Roche, for the rights to sell Alli over the counter. GlaxoSmithKline is spending an additional $150 million in a marketing campaign that includes a 60-second television ad and print ads appearing this month in most major magazines, read by 33 million people.

Bill Trombetta, professor of pharmaceutical marketing at St. Joseph's University in Philadelphia, said the comedians' attention has an initial upside. "They got your attention. This is on everyone's lips," he said. "You can't buy this kind of publicity."

But will the exposure move people to try it?

Maybe at first, said Kelly Brownell, who directs the Yale Center for Eating and Weight Disorders. But he predicts "sales will tail off fairly quickly."

"The people who will try it won't lose much weight and won't provide very good word-of-mouth," he said.

"Both the benefits and the side effects are overstated," Brownell added. "It's not going to hurt many people, and it's not going to help many people."

Marion Nestle, a nutrition professor at New York University and a frequent critic of the food industry, noted that many users may replace fat calories by eating more carbohydrates. "A lot of Alli takers will do that and wonder why they aren't losing weight," she wrote in an e-mail.

The early results are sketchy.

In the California beach town of Santa Monica, a Los Angeles Times reporter found that Alli bottles were flying off store shelves.

But in Philadelphia, once dubbed the nation's fattest city, Alli's arrival appeared to be less of a sensation.

"We do have it in stock. No one has inquired about it," pharmacist Maria Taylor at Narberth Pharmacy, said last week, echoing several other Philadelphia-area pharmacists. "Maybe it should come with a coupon for Depends," the adult diaper.

Alli contains 60 milligrams of orlistat - half the amount found in prescription Xenical. The over-the-counter version is taken three times a day with meals and costs from $60 to $67 for a month's supply. A year's worth costs at least $720.

The prescription drug's U.S. sales have been fading, from $135 million in 2002 to $93 million last year.

Despite the fact that obesity rates are surging, an effective slimming pill remains elusive. "Eating is so fundamental for human existence that the body has multiple redundant systems," said Gary D. Foster, who directs Temple University's Center for Obesity Research and Education and was a consultant to GlaxoSmithKline for its Alli Web site. "So if you block one pathway, it's evolutionarily smart to have a backup."

Alli works by blocking the digestive enzyme lipase, which aids in fat absorption. The firm estimates that Alli blocks about 25 percent of the fat that reaches the gut.

But too much fat can cause oily discharges. "You may recognize it as something that looks like the oil on top of a pizza," an Alli brochure says cheerily.

That is what happened to Paula Miguel, 35, of Hopatcong, N.J. She was one of 400 people picked by the drug firm to receive a six-month supply of Alli for free.

She said it was hardest the first week to establish her routine to walk more and eat better.

She felt a strong urge to go after downing some greasy crab cakes at a friend's house. "When I went to the bathroom, it was orangey, like an oil," she said.

But, she said, that happened only once since she began April 18. Overall, she said, she has lost 23 pounds, falling to 170 pounds on her 5-foot-3 frame. "It's not as bad as they say," said Miguel. "I eat better ... I'm more active. For me, it works fine."

The company said users could expect to lose an average of 10 pounds in a year. But that's high, independent experts say. The more potent prescription version helped participants lose an average of 6.3 pounds by the end of a year, according to researchers who analyzed 50 studies for a 2005 article in the Annals of Internal Medicine.

Paul Woolf, chairman of the department of medicine at Crozer-Chester Medical Center in Chester, Pa., was on the FDA advisory committee that in 2006 recommended that Alli be freed from prescription status.

He called Alli "a real niche product" that causes modest weight loss.

"No one is going to abuse it," he said. "They're going to be very unhappy if they do."

Via South Bend Tribune

Visit Proactol official site - the best natural alternative to Alli

Alli executive promoter lost over 60 pounds with Alli

There will be no need to audition models for an ad campaign when Britain's largest drugs company launches its "next big thing" in America's $15bn (£8.4bn) diet industry.

The executive in charge of promoting GlaxoSmith-Kline's slimming wonderdrug, Alli, can supply his own "before and after" photos. He's been taking the pills for three years and has slimmed down by 60 pounds from his original 275 pounds. Steven Burton hopes the story of his personal battle with obesity will help Glaxo make money in a market that is unpredictable and prone to fads.

The drug works by preventing the body from absorbing about a third of the fat in meals and, as that fat has to go somewhere, users are prone to multiple visits to the loo and incontinence, it is claimed. Now, the Public Citizen, a consumer health group, argues that Alli could cause colon cancer. GSK denies the claim.

But they admit the side-effects may be off-putting. "I'll never forget having a fish sandwich and loading it up with tartar sauce and having French fries," says Mr Burton. The result was "a classic oops" and a dash home for a change of clothes.

But, as Mr Burton says: "I had a doctor who was telling me pretty bluntly that it was time to do something about my blood pressure and high cholesterol for the sake of my kids. That's pretty motivating."

GSK is making Mr Burton's warts-and-all account of the drug available at the start of a marketing campaign that will accelerate over the summer. That is when the company is expected to win approval to launch Alli over-the-counter in US pharmacies. The pill is currently available only on prescription, under the brand name Xenical.

GSK paid $100m for the US rights to Alli, so Mr Burton is under pressure.

The company knows that dieters swap their experiences of the latest pills, potions and meal-time strategies, so that the success of a new weight-loss aid will be determined more by word-of-mouth than by a traditional corporate marketing machine.

GSK is also experimenting with new viral marketing techniques. It is already trying to create an online community of dieters at its QuestionEverything.com website. This currently provides information and invites discussion on healthy lifestyles and existing dieting techniques, but when regulators give Alli the go-ahead, it will certainly start guiding them towards considering the product.

Public Citizen has put GSK on notice that its marketing techniques will be under scrutiny. The group wants Xenical banned.

Most of all, though, Mr Burton needs users to get to know how Alli works and how to use it in order to reduce the likelihood of unpleasant side-effects. He thinks that is done better through online discussions.

"If you don't stay with the program, you're at risk for things like having to go to the restroom more frequently. We don't want people to be surprised," he says.

Via news.independent.co.uk

Best weight loss pills article

Many doctors are not loyal to Alli

The recent debut of Alli, the first over-the-counter slimming pill approved by federal regulators, no doubt has some dieters dashing to drugstores and supermarkets. But shortly thereafter, critics warn, they'll be dashing to the bathroom.

Alli is a lower-dose version of the prescription drug Xenical, which blocks about 25 percent of fat from being absorbed into the body by attaching itself to fat-dissolving enzymes. Problem is, the unabsorbed fat then may exit forcefully and frequently.

"We have the makings of some very embarrassing moments," says Jeffrey Novick, nutrition director for the Pritikin Longevity Center & Spa in Aventura. "This is not new news. Just old news repackaged."

Dr. Andrew Larson, bariatric surgeon at JFK Medical Center in Atlantis, isn't an Alli fan, either.

"I think it's going to be a total flop," he says. "Some people might expect a little buzz, like you'd get with Dexatrim or other diet pills. But with this, you're not going to feel anything — except the side effects."

Alli literature states: "While no one likes experiencing treatment effects, they might help you think twice about eating questionable fat content. If you think of it like that, Alli can act like a security guard for your late-night cravings."

An article in last week's Wall Street Journal, meanwhile, gives potential buyers some math to chew on:

A half-cup serving of Häagen-Dazs ice cream has about 320 calories and 19 grams of fat. Alli, which is taken with meals, would stop the body from absorbing about 4.75 fat grams or about 43 calories.

If you consume 2,000 calories a day and eat 30 percent fat, the fat-blocking benefits of Alli would translate to approximately 150 calories a day. A pound of weight loss equals 3,500 calories.

Critics insist that if you're committed to healthier eating and exercise, like Alli recommends, you don't need the drug.

"Why bother?" says Dr. Kenneth Woliner, a family practitioner in Boca Raton. "The only advantage of this pill is if you can't stop yourself from eating regular cheese or the skin off a chicken. You'll quickly regret it. But if you cut out the fat, you're doing what you need to do anyway."

Xenical (generically known as orlistat) has been available in 120-milligram pills since 1999, with prescriptions falling from 1.5 million in 2002 to 623,000 four years later. GlaxoSmith Kline acquired the over-the-counter rights from Roche in February and spent $150 million aggressively marketing Alli, which hit stores June 14.

There's an Alli book, Are You Losing It?, with diet tips and low-calorie recipes. And www.myalli.com offers a message board and personalized action plan.

GlaxoSmithKline says dieters can lose 50 percent more weight with Alli (pronounced AL-eye) than with dieting alone. The 60-milligram pill, taken three times a day, doesn't suppress appetite or affect the brain.

But doctors are concerned that Alli, approved by the U.S. Food and Drug Administration for adults 18 and older, also may block absorption of fat-soluble vitamins, such as A, D, E and K.

"Low vitamin D can push you toward dry skin, psoriasis, depression and cancer," Woliner says, adding that the drug doesn't distinguish between "bad" fats and "good" ones, such as the essential fatty acids found in fish oil.

Insufficient vitamin D also may raise the risk of brittle bones, gum disease and diabetes.

Woliner predicts that consumers will buy Alli only once or twice, which still means a hefty payday for GlaxoSmithKline.

Walgreens and CVS, for example, charge $49.99 for a 60-pill starter pack and $59.99 for 90 pills. Publix charges $46.99 for the starter pack and $69.95 for 120 pills.

"I don't think it's going to be a success," Larson says, advising people to eat more fiber and choose healthier foods instead. "I personally don't like it at all. It's a weak pill."

Via www.palmbeachpost.com

Alli slimming pill hits stores - experts warn of side effects, misuse

For two years, George Hegedus has avoided expensive diet plans and made it to the gym barely three times a week. At 270 pounds, the Coconut Creek, Fla., resident said he needs something to help combat the fat calories.

So when alli, the first federally approved over-the-counter slimming pill, hit South Florida drugstore shelves Thursday, he drove to a Walgreens store on his lunch hour and bought a starter pack: 90 pills at $59.99.

"I hope it helps take calories off, but it's not a magic pill," said Hegedus, 42, a structural engineer.

South Florida drugstores reported growing consumer interest in the new slimming pill, which is being rolled out nationwide this week with an unprecedented $150 million marketing campaign. Although the drug has been available at greater strength by prescription since 1999, this is the first time it is available over the counter to overweight adults.

The pill works by blocking about 25 percent of the body's absorption of fat in the digestive system by attaching to natural enzymes that would otherwise break down fat.

Alli's London-based manufacturer, GlaxoSmithKline, recommends taking it along with a low-fat diet and exercise. Consumers who don't stick to a low-fat diet can experience some unpleasant side effects, such as oily discharge, diarrhea and gas.

The Food and Drug Administration approved the pill in February, at half the strength of its prescription version, sold under the name Xenical. GlaxoSmithKline is promoting the pill with books, a TV commercial and educational CDs.

Drugstore representatives said many consumers were putting in pre-orders for the drug before it hit the shelves Thursday.

"We've been getting a lot of calls and we've taken a number of pre-orders through the Web site," said Carol Hively, a spokeswoman for Walgreens. "We expect this to be a big product."
But dieticians and pharmacists say that, despite the buzz, it does not change the classic formula for weight loss: eating less and moving more.

Jan Schuman, a pharmacist at Boca Pharmacy, said the key to losing weight is behavior modification.

"I'm on a diet now. I'm exercising and can do without alli," Schuman said. "I don't eat that much fat."

Schuman said taking alli and having a high calorie intake is like diabetics eating sugary foods and injecting more insulin into their bodies. He urges people not to "play a game" with themselves by thinking the pill will solve their problem, and instead focus on a good diet and exercise.

GlaxoSmithKline mailed fliers and educational material to drugstores, but Schuman said he has not heard from the company on counseling those who buy alli.

Via SunHerald.com

Actually alli is half strengh of Xenical slimming pill which is well known and proved efficacy although many people noticed side effects. Alli does have the same side effects like Xenical.

Here they are:

• loose stools
• too-frequent stools
• uncontrollable bowel movements
• gas with an oily discharge

Natural fat binder Proactol showed approximately the same efficacy in blocking fats like alli, except for no side effects noticed from testers who took it.

People using Proactol since February 2007 (the month it's become available for public) also noticed no side effects and increased weight loss rate as compared to routines without taking Proactol.

It seems natural because Proactol active ingredient is based on Opuntia Ficus Indica fiber, known for thousands of years for it's strong binding capacities. Scientific researches by Bio Serae Laboratories discovered great fat binding power of Neopuntia (made from the fiber) and several clinical studies proved that it can be used for safe weight loss.

So make your choice towards natural and safe weight loss aid and please remember that if other people reach weight loss success it's available for you too!

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