Weighing a Pill For Weight Loss

By Sally Squires
Tuesday, January 24, 2006

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 Johns 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 GlaxoSmithKline (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 George 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 Samuel 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 Johns 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.

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