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Weighing a Pill For Weight Loss

"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 Gary Foster, clinical director of the University of Pennsylvania's Weight and Eating Disorders Program. Foster 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. ยท

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