OTC Xenical?

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Panel Supports Offering Diet Pill Orlistat Over the Counter

Associated Press

Tuesday, January 24, 2006; A02

A panel of doctors and scientists recommended yesterday that the Food

and Drug Administration approve over-the-counter sales of a weight-loss

pill orlistat, marketed in prescription form as Xenical.

GlaxoKline Consumer Healthcare still needs final FDA approval. The

FDA approved the prescription version of the fat-blocking pill in 1999.

The advisory committee voted 11 to 2 to recommend approval after a

day-long hearing. The agency usually follows the recommendations of its

expert panels.

In six-month clinical trials, obese people who took orlistat lost on

average 5.3 pounds to 6.2 pounds more than did those who were given

dummy pills.

But the pill's effect ends once its use is stopped, said Golden, a

medical officer in the FDA's division of metabolism and endocrinology

products. A previous study showed progressive weight gain in patients

after they discontinued use of orlistat, Golden said.

http://www.washingtonpost.com/wp-dyn/content/article/2006/01/23/AR2006012301507.\

html?referrer=email

Weighing a Pill For Weight Loss

By Sally Squires

Tuesday, January 24, 2006; HE01

A government committee of health experts yesterday opened the door to

selling Orlistat, a prescription weight-loss drug in a reduced dosage

directly to consumers.

While the Food and Drug Administration (FDA) still must approve the

switch, the agency often follows the advice of its experts. If it does,

Orlistat (xenical) -- currently sold only by prescription -- could be

available over-the-counter (OTC) later this year. But it's important to

know that the weight loss that's typical for users of the drug -- 5 to

10 percent of total weight -- will be less than many dieters expect. And

many consumers may be put off by the drug's significant gastrointestinal

side effects, including flatulence, diarrhea and anal leakage.

Nor is Orlistat a quick fix for unwanted pounds. To achieve any weight

loss, users must also eat fewer calories and exercise more.

" It's not a miracle drug, " notes Lawrence Cheskin, director of the

Weight Management Center at s Hopkins Medical Institutions in

Baltimore, who conducted a study of Orlistat in adolescents. " None of

these [weight loss] medications are. "

Orlistat was approved as a weight loss and weight maintenance drug by

the FDA in 1999 to treat obese and overweight people -- those with a

body mass index of 30 or higher -- and overweight people (with BMI of 27

or higher) who already have weight-related health problems including

diabetes, heart disease or high blood pressure.

More than 100 studies involving some 30,000 patients have been conducted

with Orlistat, according to GlaxoKline (GSK) Consumer Healthcare,

the maker of Orlistat, which has petitioned the FDA to permit OTC sales

of the drug. The company says that 22 million people in 145 countries

have taken the drug. " Orlistat is a very safe and effective drug with a

long history of use around the world, " says Quesnelle, president

of GSK Consumer Healthcare, North America.

In the longest study of Orlistat, participants who took the drug in

addition to eating fewer calories and increasing exercise shed up to 12

percent of their body weight the first year. But by the fourth year of

the study, they had regained some pounds. Overall, they lost about 7

percent of their body weight, compared to 4 percent for a control group

that dieted and increased physical activity but didn't take the drug.

The 7 percent figure works out to about 18 pounds for someone who weighs

250.

" That's little difference in weight, but significant in terms of medical

benefits, " notes Klein, director of the Center for Human

Nutrition at the Washington University in St. Louis School of Medicine.

Those lost pounds translate to lower blood pressure, improved blood

cholesterol levels and reduced risk of diabetes.

While Americans spend an estimated $1 billion on nonprescription weight

loss products, few if any of those products have undergone the rigorous

testing that is required by the FDA for prescription medications. Some

weight loss experts say making Orlistat available directly to consumers

broadens the proven options available to people trying to reach a

healthier weight. " It's very exciting, " Klein says.

But " the problem with Orlistat are the side effects, " notes s

Hopkins endocrinologist Aniket Sidhaye, co-author with Cheskin of a

recent scientific review of Orlistat and other prescription weight loss

drugs.

At the current recommended prescription dose -- 120 milligrams taken up

to three times per day, for example up to 360 milligrams daily -- about

70 percent of users experience gastrointestinal complications, Klein

says. They range from flatulence and increased bowel movements to

diarrhea and anal leakage.

That's because Orlistat works by blocking fat absorption in the

intestine. When fat that's eaten isn't absorbed, it must be eliminated.

Thus, the gastrointestinal problems.

" This medicine can make you intolerant to all fatty foods, " Cheskin

says. " You might like ice cream, but you probably won't eat it, because

it's simply not worth it. "

The side effects appear to be worse during the first few weeks of use

and then taper off as many people learn to reduce their intake of fat.

That switch can also help with weight loss, provided that the fat isn't

replaced with calories from other foods.

Those who experience significant gastrointestinal distress with Orlistat

often stop taking the drug. Both studies and clinical experience suggest

that once they do, the gastrointestinal problems disappear.

Not everyone is convinced that the drug should be on the market either

by prescription or over-the-counter. Orlistat is on the Worst Pills list

compiled by Public Citizen. " The switch of Orlistat to OTC status would

be a serious, dangerous mistake in light of its marginal benefits,

frequent co-existence of other diseases, common, bothersome GI

[gastrointestinal] adverse reactions, significant inhibition of

absorption of fat-soluble vitamins, and problematic use in the millions

of people using warfarin or, less commonly, cyclosporine, " notes Public

Citizen director Sid Wolfe.

In a statement issued yesterday, Wolfe pointed out that prescriptions of

Orlistat dropped in the United States from 2.6 million US prescriptions

in 2000 to 1 million in 2004. " It is clearly in GSK's and partner

Roche's interest to seek OTC approval, " Wolfe told the FDA committee and

urged them to " reject this desperate attempt to revive this barely

effective drug by an OTC switch. "

Here's what else you need to know about Orlistat, which GSK plans to

market as Alli:

It won't work alone . Orlistat makes " weight loss easier, but not

effortless, " says , clinical director of the University of

Pennsylvania's Weight and Eating Disorders Program. worked with

GSK to develop an online, year-long weight loss plan for those who take

the drug over-the-counter. " You can't just take the pill and sort of

check out, " he says, noting that counting calories and increasing

physical activity are still important. Plus, Orlistat only is effective

when it's taken with food.

Prepare to pay. GSK vice president Steve Burton says that Alli will

probably cost " about the same as a soda and a bag of chips, " or about $2

to $3 per day. But that's for a 60 milligram dose -- half of what has

been modestly effective in clinical trials. Studies show that weight

loss is smaller at lower doses. (A 30-day supply of prescription

Orlistat runs about $160 or about $6 per day.)

Calories still count . Some people try to avoid Orlistat's side effects

by skipping high-fat fare but overeating low-fat or nonfat foods. " If

someone complains that they are hungry all the time, they probably

should not choose to take Orlistat, " Cheskin says.

Plan on taking a multivitamin . Some key vitamins are not well absorbed

when Orlistat is used. Among them are vitamins A, D, E and K, which are

important for eyesight, bones, immune function and more. Users of Alli

will be advised to take a multivitamin daily to make up for the loss.

Figure on long-term usage . Studies show that once the drug is stopped,

weight usually returns, suggesting that those who take Alli will likely

have to stay on it long-term or cycle on and off it. ·

http://www.washingtonpost.com/wp-dyn/content/article/2006/01/23/AR2006012301270.\

html?referrer=email

--

ne Holden, MS, RD < fivestar@... >

" Ask the Parkinson Dietitian " http://www.parkinson.org/

" Eat well, stay well with Parkinson's disease "

" Parkinson's disease: Guidelines for Medical Nutrition Therapy "

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