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.”