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.
"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. ·
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