June 25, 2007 issue - GlaxoSmithKline has a tip for people who decide to try Alli, the over-the-counter weight-loss drug it is launching with a multimillion-dollar advertising blitz—keep an extra pair of pants handy. That's because Alli, a lower-dose version of the prescription drug Xenical, could (cue the late-night talk-show hosts) make you soil your pants. But while Alli's most troublesome side effect, anal leakage, is sure to be good for a few laughs, millions of people who are desperate to take off weight may still decide the threat of an accident is worth it.

Unlike traditional diet pills, Alli, the first over-the-counter weight-loss product approved by the FDA, is not an appetite suppressant. Instead, it prevents the gastrointestinal system from absorbing about 25 percent of the fat a person consumes. If you eat more than the recommended 15 grams of fat at a meal, you may experience cramps and the uncontrollable escape of those extra fat grams. For New Jersey native Paula Miguel, 35, however, that's just the incentive she needed to stay on track and lose 20 pounds. "I see Alli as a disciplinarian," says Miguel. "It keeps me accountable for everything I eat."

While many nutritionists agree that Alli can help block the absorption of fat calories, they are careful to note that if people are not dedicated to changing their eating habits, weight loss will be small or nonexistent, and the side effects will eventually cause them to stop taking the drug. "For some people who are extremely motivated and don't mind a little bit of leakage, this may work for them," says Elisa Zied, a nutritionist from New York City. Zied is quick to add that Alli users should be sure to take a multivitamin every day, since the drug also decreases the absorption of fat-soluble minerals and vitamins such as E, A, D and K.

Critics say it's the low-fat, reduced-calorie diet Alli users are encouraged to follow that results in real weight loss. A new companion book, "The Alli Diet Plan," by Dr. Caroline Apovian, aims to maximize the drug's weight-loss potential with detailed meal plans and more than 200 low-fat recipes. But there's not much in the book that can't be found in lots of other diet books that don't endorse a particular weight-loss product. Dr. Carla Wolper of the New York Obesity Research Center says Alli offers dieters a slight edge, but permanent change comes from a change in attitude and behavior. GlaxoSmithKline says people who use Alli lose 50 percent more weight than people who follow the same regimen but forgo the drug. All joking aside, Alli, like Xenical, has been proved to be safer than the OTC appetite suppressants, which can cause heart and kidney damage and even seizures in some users.

The drugmaker hopes to stem the number of Alli dropouts by including with each $50 starter kit a weight-loss journal and a calorie and fat counter. In addition, the company is sponsoring an online behavioral support program. Dr. Vidhu Bansal, who led GlaxoSmithKline's Alli clinical trials, says that people who are looking for a quick fix shouldn't bother buying the drug: "People have to be committed to losing weight. They have to accept that they have to make a lifestyle change to get healthy." More than 60 percent of Americans can be classified as overweight or obese. With the economic impact of obesity in the United States said to top $122 billion a year, commitment to a healthy lifestyle seems to be one thing we don't have. So perhaps we need the threat of you know what.

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