Lowdown on OTC Weight-Loss Drug

xenicalBy Sally Squires, Washington Post Staff Writer

The Food and Drug Administration recently approved the first nonprescription drug for weight loss. Alli (pronounced AL-eye) is slated to hit shelves this year, according to its maker, GlaxoSmithKline (GSK). That move has been denounced by some who say it should not be made so readily available because of limited efficacy and safety concerns.

Before you even consider this drug, there are some facts you need to know and some questions to ponder:

Gosh, how much weight can I lose with this new drug? First, the drug isn't new. It contains orlistat, a weight-loss medication that has been sold by prescription as Xenical for nine years worldwide and since 1999 in the United States. There have been about 100 studies of the drug involving some 30,000 people. The results suggest that users can shed as much as 50 percent more weight than they would by diet alone.

That sounds great. Where do I get this stuff? Not so fast. First, you should talk with your doctor before considering taking any medication rather than simply changing your lifestyle, and discuss whether there are particular safety concerns you should be aware of.

You'll have to wait until summer for Alli to be available at pharmacies, anyway. Even then, most users shed only about 5 to 10 percent of their body weight -- less than many dieters dream. But it's still an amount linked to significant health benefits. Let's do the numbers: If you weigh 200 pounds, that works out to 10 to 20 pounds. One more thing: Alli is designed to be used only as part of a behavioral weight-loss program that GSK says is not for everyone.

What does that mean? In short, you still have to do all the familiar things to lose weight: cut calories and exercise more. In fact, GSK says that if you're not prepared to "be a committed consumer" by taking these steps, then it's best not to take Alli.

Well, if that's the case, how does Alli help? Unlike some other weight-loss drugs, Alli doesn't suppress appetite or work in the brain or central nervous system. Its target is the intestine, where it acts as a fat blocker by preventing up to 25 percent of fat eaten from being digested. So you absorb less fat when you eat, and that translates into fewer calories, which in turn can lead to weight loss.

How do you take it? Alli comes in 60-milligram capsules. That's half the amount found in prescription Xenical. You take one capsule with each meal.

Is that it? No. You're also urged to follow a low-fat, reduced-calorie program. GSK advises eating no more than 15 grams of fat per meal, less than the amount found in a mere three ounces of porterhouse steak. And far less than the 27 grams in either a single fast-food burger with cheese or two pieces of fried chicken. So don't expect to pig out and then take Alli to block the fat. It won't work.

Anything else? Yes, GSK has designed a year-long online behavioral modification program to be used with Alli. It's free, but to access it, you'll need to put in a special code from the box of Alli that you buy.

Okay, so how much is this going to cost me? And what if I don't use a computer? Steven Burton, vice president of GSK's Weight Control Division, said Alli will cost about $1 to $2 per day. If you're without a computer, there are seven pocket guides available for meal planning. They include help with making smart food choices and ideas for boosting physical activity. And about a month before Alli hits the market, the company plans to release a paperback book titled "Are You Losing It?" to be sold at pharmacies that carry the drug.

But the main parts of the behavioral program are online, so you may need to get more computer comfortable.

Hmm, are there any downsides to Alli, like those heart problems that I heard about with fen -phen? All drugs carry some risks; Alli is no exception. But there have been no heart problems linked to it as with fen-phen because the drug acts only in the intestines.

To cover the nutritional bases, however, you'll need to take a multivitamin daily. GSK advises doing that because, in blocking fat absorption, Alli could also block absorption of vitamins A, D, E and K. They're the so-called fat-soluble vitamins that are important for vision, immunity, bones, blood clotting and more. So it is important to make sure you still get enough of those vitamins.

Even so, some critics call the move to make Xenical available as Alli without a prescription "the height of recklessness." In April 2006, the consumer group Public Citizen petitioned the FDA to block the proposed switch, citing concerns about a link between the drug and development of precancerous colon lesions in rats, called aberrant crypt foci. Two studies suggest that Xenical can cause these precancerous growths.

"We strongly urge people not to use this potentially dangerous drug," Public Citizen's director, Sidney M. Wolfe, said when the FDA announced its decision this month. "And we predict that like the rapidly declining sales of the prescription version, the over-the-counter version will turn out to be a loser after enough people have a bad experience with it."

The company calls those concerns unfounded. "The drug is safe and effective when used as directed," said GSK's Vidhu Bansal, director of medical affairs in the Consumer Healthcare Division. "As the most extensively studied weight-loss medication on the market, the safety and efficacy of orlistat is very well established."

source The Washington Post