GlaxoSmithKline Allies With Web For Diet Launch

As the maker of the first weight-loss drug with regulatory approval, GlaxoSmithKline faced a dilemma: how to differentiate its product, Alli, from the many fly-by-night remedies promising weight loss without effort. To get users to buy into its assertion that long-term weight loss can only be achieved in combination with lifestyle changes, the pharma company is taking a page from Yahoo and MySpace by constructing its own portal that in many ways resembles a social network.

To accomplish this, GSK is joining the ranks of advertisers that are using the Web to become content creators and build communities around their products, like Anheuser-Busch's ambitions with Bud.TV and the vibrant running community Nike has tapped with NikePlus.com.

For Alli, due to launch in June or July, the Web is not just a marketing conduit, but an essential component of the product. Unlike many diet pills, Alli is marketed as a complement to a strict diet and exercise regimen. The over-the-counter drug, which blocks fat production in the intestines, can increase weight loss by 50 percent, GSK claims. But only if users commit to a regimen of proper eating and exercise—a long-term lifestyle change—and a six-month program of the drug, said Steve Burton, vp of weight control for GSK's consumer healthcare division.

"It's an innovative and honest voice in a landscape that's filled with products that make exaggerated claims," he said.

GSK's interactive agency, Dallas-based independent imc2, has built a Web portal for Alli users that goes beyond providing product information. MyAlliPlan.com will be available to Alli users through a registration code on each packet. The site will collect the users' weight-loss profiles, build customized meal plans and provide feedback on their progress. Visitors will then get customized advice, with the system sensing, for example, if they have hit a wall in their weight loss and need to adjust their daily calorie intake. Message boards and blogs will let users advise and encourage each other, and advice from experts will be available.

"It truly is designed as a destination to help people not just educate themselves, but to help them along the way," said Beth Kuykendall, vp and managing director of imc2.

Although consumers are turning more and more to the Web for health information, there is evidence that there is a dearth of content to satisfy demand, said Larry Mickelberg, svp of strategy at Medical Broadcasting Company, a Digitas-owned pharma agency in Philadelphia. He noted that over 80 percent of Web users have searched for healthcare information, yet under 20 percent found satisfactory answers, according to a 2006 study from Jupiter Research. Pharma companies have the resources to fill that gap, he said. "There's already latent demand in the marketplace that's not being served by most pharmaceutical marketers," he said. "Their audience has beaten them to the Internet."

With that in mind, GSK launched QuestionEverything.com, a site dedicated to debunking myths about fad diets and weight-loss supplements, before Alli had received FDA approval. The site does not mention Alli, though it carries notice that it was built by GSK. Burton said the main purpose of the site was "public service," although it did collect visitors' e-mail addresses.

GSK is taking its publisher role a step further in its pre-launch marketing with the release of a 140-page book, Are You Losing It?, which aims to deliver sensible weight-loss information, and 20 pages of Alli background.

While GSK said it's keen to be seen as a trusted source of information about weight loss, pharma companies should tread lightly when doubling as content publishers, said Brad Aronson, evp at Avenue A/Razorfish. It is often more effective, even for new treatments, to partner with already trusted health publishers and communities, like WebMD and MayoClinic.com.

"They're not going to the pharmaceutical company to learn about a disease or condition," he said. "We want to be realistic that for conditions where there's a lot content out there they're not going to look to us for that content."

Diet Pill alli (Low-Dose Xenical) May Ultimately Be Marketed Worldwide

Diet pill alli (low-dose orlistat), which earlier this month became the first FDA-approved over-the-counter diet drug, may ultimately be available in countries around the world.

Roche, which sells the prescription version of orlistat called Xenical, announced on Feb. 20th that it had granted GlaxoSmithKline an exclusive license to sell the half-strength version in countries outside the U.S. and Japan.

Roche had licensed the U.S. nonprescription rights to Glaxo in 2004.

Roche said it will retain all rights for the prescription version and will continue to market Xenical worldwide.

alli, which reduces the amount of fat the body absorbs from food, was approved by the FDA for use by overweight adults in combination with a reduced-calorie, low-fat diet and exercise.

Glaxo expects to have it on supermarket and drugstore shelves sometime in the summer.

First OTC obesity drug to be sold

The pharmacy section in your local supermarket will soon carry another weight loss drug among the range of trim-this and slim-that. But the new addition will be the first over-the-counter weight loss drug approved by the Food and Drug Administration.

Alli, which are orlistat capsules marketed by GlaxoSmithKline, hits shelves nationwide in June.

"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 FDA's Center for Drug Evaluation and Research, in an FDA news release. "[Over-the-counter] orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health."

Approval of this drug comes when obesity is rising at an "alarming rate," according to the American Obesity Association.

The National Center for Health Statistics says 30 percent of American adults 20 years old or older are obese. The percentage of overweight young people has more than tripled since 1980, according to their statistics, and overweight young people are likely to become overweight or obese adults.

The FDA originally cleared orlistat capsules for prescription use in 1999 to treat obesity. Pills with a higher doses of orlistat than the OTC version remain strictly by prescription.

Brian Jones, president of communications for GlaxoSmithKline, said since the drug's inception, 25 million prescriptions have been filled in 145 countries. Jones said patients saw 50 percent more weight loss with the drug than with diet and exercise alone.

"I just lost 30 pounds in six months just by dieting and exercising. If I had the product, just think, that would have been 45 pounds," Jones said.

Alli may be taken up to three times a day during mealtime. Nicole Whatley, University registered dietician, said dieters should divide their fat intake evenly throughout the day.

Specialists Caution About Diet Pills

Further to FDA’s approval on the latest diet pill under the brand name Alli, there has been much excitement in people who are keen to bring down their weight. Alli has been given the status of over the counter (OTC) drug in the U.S.

This drug is said to block the absorption of fat by the body. Uncontrolled bowel movement and loose stools are reported to be the side effects of Alli.

In the Indian scenario, there are many drugs and alternate remedies to bring down one’s weight. Drugs under the brand name of Obego or Obestat are said to be targeting parts of brain which is responsible for hunger. But this could have serious contra indications like high blood pressure and pulse rate.

In the ayurvedic segment, many of the formulations are not clinically tested. According to Dr Gulhati, the editor of MIMS, such drugs are illegal as they will not be passed by the government unless they are prescribed by the classical books. The combination of right kind of food and exercise alone would help in bringing down one’s weight.

Medindia on U S Government Allows Non-prescription Diet Pill
The Food and Drug Administration has approved the sale of a diet drug which can be sold without a prescription. This weight loss pill is called Alli, which was previously sold as a prescription drug by the name Xenical since 1999 in U.S.

Lose weight or lose control

Slimming effects of alli may trigger many unpleasant side effects

This no-win choice is coming soon to a drugstore near you.

A year ago, I wrote about the U.S. Food and Drug Administration's consideration of over-the-counter sales for the fat-blocking drug, orlistat. It now has the FDA's blessing: Expect to see it on store shelves this summer under the name alli (pronounced "ally").

This is no magic pill, and it isn't going to work if you live on deep-fried candy bars and consider lifting the remote vigorous exercise. alli might help you shed some extra pounds - if you work out and eat a low-cal, low-fat diet along with it.

But if you're doing that, why take a pill?

Its maker, GlaxoSmithKline, says that alli might help people lose 50 percent more than they would with dieting: that means 3 pounds instead of 2, 7.5 pounds instead of 5, 15 pounds instead of 10. No guarantees, of course.

The drug works by blocking digestion of 25 percent of the fat in your food, about 150 to 200 calories a day. Over six months, people who tested the OTC version lost 4 to 6 pounds more than those who took a placebo.

Still planning to pick up a case or two? Don't forget the adult diapers.

Sad to say, but that lost poundage comes at a price, and I'm not just talking about the $1 to $2 a day it's going to cost. The drug company refers to them as "treatment effects," which is its tidy euphemism for bowels gone wild and toxic undies.

Remember, orlistat works by blocking absorption of fat. And it's gotta come out somewhere.

What the experts are saying

• Dr. David Katz, director of the Yale Prevention Research Center, commenting on the possibility of abuse of alli by the eating-disordered:

"Anal leakage is not likely to be too socially acceptable among image-conscious teens - or anyone else, for that matter."

• Dr. Alastair Wood, FDA panel chairman, to company executives during hearings on its proposed OTC status:

"Have you considered placing a warning on the box, 'Don't take this product while wearing your new La Perla underwear'?"

What is this stuff?

Here's the skinny on the fat-blocker alli (pronounced "ally")

• What: Over-the-counter version of the prescription drug Xenical (orlistat), one of a new class of anti-obesity drugs known as lipase inhibitors and the only FDA-approved weight-loss treatment.

• Who it's for: Overweight adults following an exercise program and a reduced-calorie diet with no more than 30 percent of calories from fat, preferably closer to 15 percent

• Who it's NOT for: Anyone under 18; anyone with a body-mass index less than 27 to 30; people who already have trouble absorbing food; organ transplant recipients; people on blood-thinning drugs; diabetics or people with thyroid disease

• What it does: Prevents enzymes in the gastrointestinal tract from breaking down dietary fats into smaller molecules, decreasing fat absorption by 25 to 30 percent

• Pros: Effects limited to the digestive tract. In studies, weight loss was 4 to 6 pounds more than with a placebo over six months.

• Cons: Effects can include gas with oily discharge, diarrhea, bowel urgency and anal leakage. Study participants who stopped using the drug regained all lost weight. Calorie-counting still required.

How much fat?

• To help avoid icky side effects, the drug maker recommends that alli be taken with a low-calorie, low-fat diet - ideally 15 percent of daily calories. To put that into perspective, let's say your diet plan allows 1,600 calories a day; 15 percent is 240 calories. Divide that by 9 - the number of calories in a gram of fat - and you're allowed 26.4 grams of fat per day.

Is alli your ally?

Here's GlaxoSmithKline's "alli weight-loss readiness quiz." The company estimates at least 5 million Americans a year will use alli.

• I am willing to do the hard work to lose weight gradually.

• I am committed to following a reduced-calorie, low-fat diet (an average of 15 grams of fat per meal).

• I understand that if I take alli with a meal containing too much fat, I may get bowel changes known as treatment effects.

• I am committed to eating smaller portions.

• I am committed to making time to be more physically active.

• I will read and follow the alli label.Source: Myalli.Com

alli facts

60mg dosage in each alli pill, half the strength of the prescription version Xenical.

• A, D, E & K: Water soluble vitamins whose absorption is blocked by the drug - so you need to take a multivitamin pill as well.

• The less fat you eat - say, 15 percent of total calories - the less severe the side effects, which might subside after a month or two or last much longer.

• GlaxoSmithKline already has a Web site up for future alli users (myalli.com) that will offer support and guidance, including a customized online action plan, menus and shopping lists, lessons about meal planning, managing hunger, dealing with setbacks and a way to chat with other alli users.

More expert opinions:

• Dr. Jim Hill, director of the Center for Human Nutrition at the University of Colorado Health Sciences Center:

"The bottom line is, look at what's out there for weight loss - there are some really, really scary products. This one is not very scary."

• Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, in a petition last April asking the FDA to ban orlistat:

"This drug causes a significant increase in the incidence of aberrant crypt foci, which are widely believed to be a precursor of colon cancer. The failure to ban the prescription version - or worse, to make it much more widely available by allowing OTC sales - is a decision that is likely to increase cancer incidence. Orlistat is a drug that has shown minimal efficacy coupled with both known and potentially important serious adverse events."

• Suzanne Farrell, spokeswoman for the American Dietetic Association and owner of Cherry Creek Nutrition:

"As a dietitian, I'm concerned about over-the-counter use, since diet instruction from a health professional wouldn't be something that came with it."

Comments from diet-blog.com:

• "I took this for one day. That was more than enough for me. I decided that I would rather deal with the indignity of being overweight than the indignity of soiling myself. Whoever came up with this drug hates overweight people and wants to punish them."

Carla

• "I am 5 feet 4 inches and weigh 115. (Orlistat) is great for me, and it has worked for years with very few side effects. Really. It should be something that we all use."

April

• "I was on it when I was around (198 pounds), and I got down to (130 pounds). Without the (orlistat), I was more likely to eat bad foods because there was nothing to stop me. Now I am less likely to because I don't want to spend all day on the toilet."

Vanessa

The company says

• Steven L. Burton, vice president, Weight Control, GlaxoSmithKline Consumer Healthcare, announcing alli's OTC approval earlier this month:

"With alli, we're excited to offer a revolutionary approach to weight loss. alli is more than a pill - it's a comprehensive program that works in conjunction with a sensible diet to increase weight loss. Because weight loss doesn't happen overnight, we're starting to educate consumers now about the importance of realistic expectations, gradual weight loss and lifestyle changes."

Experts advice caution on slimming pills

Crores of rupees are spent on weight loss supplements, fad diets slimming pills and quick fix products, according to reports.

There are more than 300 million clinically obese and one billion overweight adults, reports say.

For the first time the Food and Drug Administration of the United States has given the go-ahead for over the counter sales of a weight loss compound Orlistat sold under the name of Alli.

It's a move that many say will go a long way in providing a comprehensive support programme for losing weight.

Alli has been approved for use along with a reduced calorie and low fat diet and promises to make people lose 50 percent of weight than diet alone.

The recommended dose is one 60 mg capsule three times a day with meals containing fat.

The drug blocks the absorption of fat in the intestine and calories from that fat. Glaxo claims that this will be a revolutionary approach to weight but here' s the catch.

"Orlistat's has no life threatening side effects but can have unpleasant side effects - oily spotting and uncontrollable bowel movement," says Professor Nikhil Tandon with the Department of Endocrinology at AIIMS.

Artificial control

In India there is a range of drugs available over the counter for weight loss.

Compounds like Sibutramine sold under the name of Obego or Obestat work by inhibiting the region of the brain that controls appetite.

They trick the body into thinking that it is not hungry but experts say they have dangerous side effects including high blood pressure and pulse rate.

There are also herbal and ayurvedic formulations.

"These are untried and untested. Manufactures come up with all sorts of exotic formulations that have never been clinically tried," says Dr Gulhati, the editor of MIMS.

"Many of them are illegal because drug laws don't permit the marketing of ayurvedic medicines without testing unless they are part of the classical text books old ancient texts on ayurveda.

Losing weight is a commitment that takes patience and discipline.
Magic short cuts may seem easy but weight loss pills are recommended only for people who are medically obese.

The treatment for obesity is not just about popping a pill but it must involve counseling, exercise and dietary changes.

New diet pill has icky side effects

Local health officials and diet specialists aren't exactly praising the recent approval of a weight-loss drug once prescribed exclusively by doctors to treat overweight patients.

The Food and Drug Administration recently approved Alli (pronounced AL-eye) for over-the-counter sales. The weight-loss drug is a lesser dosage of the drug Orlistat, manufactured by GlaxoKlineSmith, and will be available this summer to people 18 and older, the first time such a pill has been obtainable without a prescription.

And with the obesity epidemic growing nationwide, some health experts say the pill could come in handy for adults looking to shed some pounds. Critics, however, point out that Alli could come at a cost to your physical well-being.

For one, pharmacist Dave Smatko, owner of the Medicine Shoppe in Beaver Falls, said there are gastrointestinal side effects that include severe diarrhea. When taken with meals, Orlistat blocks about one-quarter of any fat consumed, usually 150 to 200 calories. Unabsorbed fat leaves the body in excrement, which can be loose.

"I would hope that any pharmacist would at the very least mention the biggest, worst side effect that is associated with that drug, the whole diarrhea issue," Smatko said.

Smatko, who was actually surprised to see the diet pill approved for over-the-counter use, said the pill could also cause problems for some users depending on how it interacts with fats in their diet.

Judy Wood cringes at the idea of diet pills. As director of the Beaver-based Life Changers, a weight-loss-management center, Wood has helped people since 1985 giving seminars on how to maintain proper diet and exercise. She said the truth is there is no gimmick, only old-fashioned basics of diet and exercise.

"If you don't work at changing your habits and lifestyle, once you quit taking the drug, then what happens?" Wood asked.

Sherry Wilson, co-owner of Curves in New Brighton, said it would be wonderful if there was a pill you could take to keep off the weight. Wilson said she has never taken diet pills and worries about the long-term side effects for people who do.

"I really don't think there's ever going to be a substitute for a healthy lifestyle," Wilson said.

The 60-milligram capsule can be taken up to three times a day with each fat-containing meal, along with a multivitamin at bedtime. The diet pill reduces the absorption of fat and is meant to be used along with a reduced-calorie, low-fat diet and exercise program.

The drug is not intended for people who are not overweight or who have problems absorbing food, according to the FDA.

Some experts say by helping people to lose weight, the drug has its benefits since weight loss can lower cholesterol and blood pressure, and prevent diabetes and other conditions exacerbated by obesity.

"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and Type 2 diabetes," Dr. Douglas Throckmorton, deputy director for the FDA's Center for Drug Evaluation and Research, said in a statement.

Abuse of the pill is also a potential problem, which would mean eating a lot of fatty foods and taking more than the recommended dosage. But distributors would have only so much oversight.

Smatko said the system will probably work similarly to the way pharmacists handle cold medicines containing ephedrine. The product would be kept in the back, out of the reach of body-conscious teenagers. In order to make a purchase, a person would have to produce identification and sign for the product, with limit restrictions on purchases as recommended by the manufacturer or statute.

Smatko said the prescription for a 30-day supply is so expensive - try $2.50 a capsule multiplied by 90 - many patients who began taking it never came back for a refill. Part of it was the side effect, but also Smatko added, "almost no insurers covered this item."

Once the drug goes on sale, he thinks the price will drop precipitously.

FDA sets new guidelines for diet-pill makers

Companies should prove products help people keep off weight for a year

As more Americans struggle with growing waistlines, U.S. health officials Wednesday set out their own tips for drugmakers seeking to develop products for people trying to shed pounds.

The Food and Drug Administration’s draft guidelines — more than 10 years in the making — aim to help companies develop and test new drugs and devices for treating obesity.

About a third of U.S. adults, or more than 60 million people, are obese and another third are overweight, government statistics show. Nearly a fifth of U.S. children weigh too much.

The FDA proposed that companies should prove their products can help people lose weight and keep it off for at least a year. It also urged them to study people with a body mass index of at least 30 or those with a BMI of at least 27 who have weight-related conditions such as diabetes and heart disease.

BMI is calculated as weight in kilograms divided by height in meters. People with a score of 25 to 29.9 are considered overweight, and those at 30 or higher are considered obese.

“In general, patients should have or be at significant risk for weight-related morbidity and mortality,” the FDA said.

More room for diet products
The proposed guidelines come as more drugmakers look to enter the U.S. weight-loss sector, which some analysts have said remains untapped.

Overweight individuals are at risk for other, potentially life-threatening problems. In addition to diabetes, high-blood pressure and certain cancers are also possible.

Drugs usually aim to help people lose weight by curbing their appetite or preventing fat absorption. Some devices, such as Allergan Inc.’s Lab-Band, are used in surgical procedures to limit stomach size.

Last week, GlaxoSmithKline Plc won U.S. approval to sell an over-the-counter version of Roche AG’s prescription obesity drug Xenical, called Alli.

Sanofi-Aventis is also awaiting the FDA’s ruling on its Acomplia drug, which the agency earlier this week postponed until July.

Drugmakers often rely on guidelines
Although the guidelines are non-binding, drugmakers often rely on them when developing products. Companies may take other approaches as long as they meet legal standards, the FDA said.

They could also help prompt more manufacturers to develop weight-loss solutions.

“Given the large market opportunity, the health consequences of no therapy, we were shocked that we could only find 17 companies” with products on the market or in advanced development, Susquehanna Financial Group analysts wrote in a recent research note.

FDA officials first proposed the guidelines in 1996, but they lingered until 2004, when the FDA sought public comments.

The revised version, now on the FDA’s Web site, includes advice on products for children as well as those combining two or more drugs. It also offers guidance for products aimed at patients whose extra pounds result from other medications.

“The use of weight-management products in pediatric patients, as in adults, should be contemplated only after a sufficient trial of lifestyle modification has failed,” the FDA said.

The proposal calls for studies to include a wide variety of patients from different regions and racial backgrounds.

Diet pill: ‘alli’ or enemy?

In an effort to shed even just a few pounds, some students look further than diet and exercise to find a medical way to gain their desired appearance.

At the local Westwood General Nutrition Center, which sells health supplements, vitamins and other health and diet related medications, diet pills are one of the most popular items, said Steven Nunes, an employee at the local Westwood General Nutrition Center.

But until last week, none of the diet pills that were available over the counter had been approved by the U.S. Food and Drug Administration.

The pill, called alli, has drawn both criticism and praise from experts since its increase in accessibility to the general public was approved by the FDA last week.

The pill’s approval is recommended for use by overweight adults in conjunction with a low-fat, reduced-calorie diet. It is expected to be available in stores nationwide by this summer.

And the FDA’s stamp of approval means for some students that the use of a diet pill to lose weight would not be out of the question.

Though Ben Kurtz, a third-year political science student, said he had never tried a diet before, he said if he needed to lose weight, he may turn to the newly approved pill.

“I guess if it was proven to be safe and was sold at a reasonable price ... I’d consider the diet pill,” he said.

The primary function of alli is to prevent the absorption of fats from one’s diet, thus reducing overall net daily caloric intake, according to its Web site.

Formerly, the pill was available only by prescription and was twice its current dosage.

Though alli has been approved, there are several side effects, which have caused some doctors and nutritionists to warn consumers about the pill.

While the primary side effects are gastrointestinal-related, GlaxoSmithKline Consumer Healthcare called the side effects “treatment effects,” which may be quite severe and painful.

The most common side effects are loose or oily stool and frequent and urgent bowel movements.

“If you take too much of it, it’d probably be worse than not taking the pill,” Roberts said. “Hopefully that will disallow people from abusing it.”

Sherry Rahmatian, a second-year psychology student, said she would not use the diet pill, even in its approved over-the-counter form because she is concerned about the health risks and potential side effects.

“I’ve tried to eat healthy before, to watch my diet, but I don’t think I would ever take the new diet pill, especially if I’d experience the side effects that are associated with it,” she said.

The medication works by inhibiting certain enzymes that break down triglycerides, a type of fat, in the intestine. The triglycerides are prevented from being converted into absorbable fatty acids and pass freely through the body due to the inactivity of the enzyme

The directions given from the pill’s makers state that the simple consumption of this pill will not work miracles, and it is still required that consumers exercise regularly and adjust to more healthy eating habits in order to see any form of weight loss.

GlaxoSmithKline, the company responsible for marketing alli, has said on its Web site that those who “limit fat and calories through diet, use alli capsules, and get more physically active” will lose 50 percent more weight than with diet alone.

UCLA physiological science professor Christian Roberts said the majority of weight loss will not come solely from the pill, but from a change in lifestyle that incorporates a combination of exercise and a healthy diet.

“The bulk of the weight loss will be due to the lifestyle change and not the medication,” Roberts said, citing that the dosage of the over-the-counter alli is only 60 milligrams, just half of what is prescribed normally.

Manufacturers of the pill said they are offering what they see as a new outlook on weight loss that will revolutionize how users of the drug go about their daily lives and effectively help them lose the weight they couldn’t lose by other means.

“With alli, we’re excited to offer a revolutionary approach to weight loss,” Steven L. Burton, vice president of weight control at GSK, said in a statement. “Alli is more than a pill — it’s a comprehensive program that works in conjunction with a sensible diet to increase weight loss. Because weight loss doesn’t happen overnight, we’re starting to educate consumers now about the importance of realistic expectations, gradual weight loss and lifestyle changes.”

The growing problem then becomes the actual desire for users to adapt and remain dedicated to the new lifestyle that is required for the successful implementation of alli. Roberts said users of alli looking to lose between 20 and 30 pounds will likely be disappointed due to the amount of time required to do so.

Several studies have been conducted that show that once the use of alli is stopped, participants regained much of their weight that they had initially lost.

Roberts said alli should be used only after one has been thoroughly assessed by either a dietician or nutritionist, and even then, it should be very well understood that it takes more than the simple popping of a pill to lose the weight and serious lifestyle changes must be made.

“I wouldn’t recommend it initially,” Roberts said. “I would assess, first of all, what is the person trying to do? What is the goal? How much weight loss are they trying to achieve? Have they tried to change eating habits and exercise patterns?”

And after having answered all those questions, one could find several other more effective means of losing weight at a similar pace and in a more effective manner, Roberts said.

“The effects are going to be small, and to be honest, there are other diet pills on the market that I think are more effective,” Roberts said. “I would start with just changing lifestyle and going from there.”

FDA approves first OTC weight loss pill

The Food and Drug Administration (FDA) approved an over-the-counter version of the fat-blocking diet drug Xenical last week, making it the first FDA approved weight loss product available without a prescription.

The drug will be sold under the brand name Alli and will contain about half the amount of the fat-blocking drug orlistat than the prescription version contains.

GlaxoSmithKline, the company that manufacturers the pill, expects the drug to be in stores by summer 2007.

Alli blocks the absorption of about 25 percent of the fat consumed when taken at meal times. The fat is then passed out of the body through stools and eliminates about 150 to 200 calories from fat.

Consuming a high-fat meal while using Alli can result in uncomfortable bowel changes such as loose stools or a sudden urge to use the bathroom, Brian Jones, vice president of communications for GlaxoSmithKline.

According to a press release, the recommended dose is one 60-milligram capsule, three times a day, with meals.

"It is about 60 cents a capsule," Jones said. "It is certainly affordable for most Americans. It's about the cost of a soda and a bag of chips."

The drug is intended for people 18 and older and because of the way it works, the company recommends that it be used in combination with a healthy lifestyle, exercise, and a reduced-calorie diet that contains about 15 grams of fat per meal.

"Essentially, you have to follow a low-calorie diet to be successful," Jones said. "It's not a magic pill that will cause you to lose weight in hours."

Users will lose weight steadily over time, Jones said.

Associate professor of nutritional neuroscience Rebecca Corwin said she is not an advocate of using drugs as a long-term solution for weight loss.

"I think they're okay in moderation," Corwin said. "The critical thing is that people have got to learn healthy habits if they're going to be successful in the long-term. That's the tough part."

Corwin said diet drugs work in two ways, reducing fat absorption and causing users to change their eating habits to reduce side effects.

"They reduce fat absorption in the [gastrointestinal] tract and reduce the actual amount of fat your body gets by about 30 percent," Corwin said.

"Also, if people break the diet and eat a lot of fat, they feel really uncomfortable," she said.

Users are also urged to take a multivitamin once daily because Alli has the possibility of reducing the absorption of certain nutrients, Jones said.

Corwin said she thinks taking a multivitamin could be helpful because of the vitamins that may be prevented from absorption.

"It's probably going to be the fat-soluble vitamins A, D, E and K," Corwin said. "It certainly won't hurt to take a multivitamin. Just make sure that it's no more than 100 percent of the recommended daily allowance."

Leslie Archard (sophomore-marketing) said she thinks people will take such diet drugs even though they are aware of the potentially unpleasant side effects that may happen as a result of taking the drugs.

"People are so insecure that they'll do it anyway," Archard said. "There's a strong drive to be considered attractive and they are making money off of people's insecurities."

About 31 percent of American adults, or 60 million people in the United States meet the criteria for obesity, according to the Centers for Disease Control and Prevention. About 65 percent of American adults are considered overweight.

"About two-thirds of American adults are overweight or obese," Jones said. "We need help. Maybe this is one of the things that can help us."

Why alli is different from other diet pills?

Unlike other products on store shelves, alli is a proven medicine with a comprehensive support program. To help consumers get off to a successful start, the alli package will include Welcome and Companion Guides, a Guide to Healthy Eating, a Daily Journal, a Calorie and Fat Counter, Quick Fact Cards, and free access to an individualized online action plan at http://www.myalli.com.

"With alli , we're excited to offer a revolutionary approach to weight loss," says Steven L. Burton, Vice President, Weight Control, GlaxoSmithKline Consumer Healthcare. " alli is more than a pill - it's a comprehensive program that works in conjunction with a sensible diet to increase weight loss. Because weight loss doesn't happen overnight, we're starting to educate consumers now about the importance of realistic expectations, gradual weight loss and lifestyle changes. That's the way to see results, and with alli , we know they can do it."

Starting today, GSK Consumer Healthcare will gear up production to have the product ready for shipment and in stores by the summer. The company is using this period to build awareness and understanding about the product and its intended user �" with the message �" alli is not for everyone. It's for the committed consumer who can follow a reduced-calorie, low-fat diet. For this consumer, alli will provide a unique, proven approach to weight loss, offering straight talk, educational tools and an online support program �" myalli.com.

GSK - alli: learn from the mistakes of others

Advertising prescription medicines direct to consumers is illegal in Australia, so one side benefit for pharmaceutical companies of having a drug reclassified from "prescription only" to "pharmacist only" or "pharmacy medicine" is that the drug can then be advertised, potentially expanding its market.

This happened to the weight loss drug Xenical (aka olistat aka "alli"), initially available only on prescription, which in 2004 was rescheduled as a "pharmacist only" drug and in 2006 given limited advertising approval.

However, this may be short-lived.

The classification of Xenical will be re-considered next week after complaints from consumer groups and the general public that it was being promoted as a weight loss solution to people for whom the drug is not recommended, including young people under 18 where the safety of Xenical has not been established.

These complaints focussed on the advertising of Xenical during television programs targeting young people. The advertisements have now been withdrawn after they were found to breach the advertising code for medicines. But not before they were seen by the estimated 1.3 million viewers of the popular Australian Idol program, including many who were aged under 18.

FDA approves first over-the-counter diet pill, Alli

The Food and Drug Administration (FDA) has approved its first over-the-counter diet pill on Feb. 8. drug goes by the brand name "Alli" and is produced by pharmaceutical company GlaxoSmithKline. "Alli" contains half the dose of the prescription diet drug, "Xenical".

Doctors say the pill, to be taken before each meal containing fat, works by not allowing the user's gut to digest consumed fat. "Alli" works by blocking the absorption of roughly 200 calories of fat from each meal. Undigested fat is removed in the stool.

However, there are gastrointestinal side effects to the pill such as diarrhea. Patients can expect to lose between six to 10 pounds during the course of six months to a year.

Dr. Adi Mehta, weight loss expert at Cleveland Clinic said, "This medication works in the gut. Basically what it does is not allow the gut to digest the fat that you take in. If you digest it, you can't absorb it. If you can't absorb it, therefore it can't go in to the wrong place in your body."

F-D-A researchers say the drug is for people 18 and older and say it should be used in combination with a diet and exercise program.

Talking about gastrointestinal problems, Dr. Mehta says these can help people lose weight.

"The beauty of this medication is because you don't want to have the oily stool and the discomfort from it, you tend to start to restrict how much fat you take in. And by doing that, you're sticking to a diet and to that extent, you're going to get enhanced ability to lose weight."

'Alli' is not for people who've had organ transplants. And people taking medicine for high blood pressure and diabetes should talk to their doctor before using the drug.

The new diet pill, estimated to cost below two dollars, is expected be on store shelves beginning this summer.

Alli: FDA approves first over-the-counter weight-loss drug

Overweight adults who are struggling to shed excess pounds have a new over-the-counter (OTC) weapon in the fight against obesity.

The weight-loss drug orlistat (Xenical) was originally approved in 1999 as a prescription drug to treat obesity. Now, the Food and Drug Administration has approved a reduced-strength OTC version of orlistat (Alli) for adults age 18 and older.

Alli promotes weight loss by decreasing absorption of fat by the intestines. The capsules are taken with meals, up to three times a day. It sounds like a dieter's dream, but there are no shortcuts to permanent weight loss. Alli is intended to be used only with a reduced-calorie, low-fat diet and regular exercise.

The most common side effects of Alli include diarrhea and gas with oily spotting. These and other bowel changes can be minimized by eating a low-fat diet. A daily multivitamin is recommended to offset the loss of fat-soluble nutrients, such as vitamins A, D and E.

Alli shouldn't be taken by anyone who has a healthy weight, who's taking cyclosporine, who's had an organ transplant, or who has problems absorbing food. The drug also may pose risks for anyone who takes blood-thinning medication or has diabetes or thyroid disease. Some studies have associated the prescription-strength version of the drug with precancerous changes in the colon.

Alli is expected to be available by summer 2007.

What does this mean to you? If you're struggling to lose excess weight or you have medical complications of obesity, an OTC weight-loss drug may be an appealing option. Remember, however, weight-loss drugs aren't a silver bullet for weight loss. And they aren't a good choice for everyone who's overweight.

It's best to lose weight through a healthy diet and regular exercise. But if you're already following a reduced-calorie, low-fat diet and exercising regularly, Alli may help you lose additional pounds. Work with your health care provider to evaluate the potential benefits and risks of Alli or any other weight-loss drugs. As a team, you can create the most effective weight-loss plan for you.