Get ready for alli!

You won't lose weight in your sleep or shed pounds while eating anything you want -- that's the sobering message from the maker of a weight loss pill poised to hit shelves next month. GlaxoSmithKline on Tuesday opened an educational exhibit in New York City to prepare the country for alli, the first over-the-counter diet pill approved by the Food and Drug Administration. While the cautionary marketing approach may not trigger stampedes to the counter, analysts say the drug's fate hinges on the pharmaceutical giant's ability to convince people that diet pills aren't a magic bullet.

GlaxoSmithKline is counting on alli to become a star money maker. The company is spending $150 million on marketing alli this year, making it one of the drug maker's biggest campaigns to date. "We've done everything to go out of our way to be honest," said Steve Burton, vice president of the weight control division at GlaxoSmithKline Consumer Healthcare. "We're taking a very different approach than the fad diets people are constantly exposed to." In clinical trials, the FDA says that people using alli lost an additional 2 to 3 pounds for every 5 pounds lost through diet and exercise. The FDA approved alli, called Xenical by prescription, to be sold over the counter in February.

When taken with meals, the drug blocks the absorption of about one-quarter of any fat consumed. That fat -- about 150 to 200 calories worth -- is passed out of the body, potentially resulting in loose stools. About half of patients in trials experienced gastrointestinal side effects, including leakages and oily discharges. GlaxoSmithKline is frank about those unpleasant effects, which it says can be controlled if the drug is used properly. The campaign stresses the importance of keeping meals under 15 grams of fat to avoid effects. Educational materials even recommend people start the program when they have a few days off work, or to bring an extra pair of pants to the office. Experts say a failure to adequately prepare consumers about the effects contributed to Xenical's limited success.

The alli event comes a day after the company's shares dropped almost 8 percent when a report this week found the company's widely prescribed diabetes pill raised the risk of heart attacks and possibly death. Some experts called it another Vioxx-like example of the U.S. government failing to protect people from an unsafe drug. Alli only affects the digestive system, Glaxo says, and is the only safe over-the-counter diet drug that's been shown to work. Labeling indicates alli is appropriate for anybody who is overweight, or has a body mass index of 25 or higher. A body mass index over 30 is considered obese. Two-thirds of the U.S. population is estimated to be overweight or obese.

Bonnie - I will be shocked if this drug is a success based upon the details in the above AP report. I shudder to think of the long-term outcome of a drug that blocks one-quarter of all fat consumed and causes these kinds of GI symptoms.