Battling the Bulge? A New Weight-Loss Drug Gains Approval
A new weight-loss weapon is set to hit stores this summer, after getting the nod yesterday from the Food and Drug Administration. The new version of orlistat, to be named Alli, will be packaged at half the strength of its prescription counterpart, Xenical, and will be the only FDA-approved weight-loss product available over the counter. The agency emphasizes that it should be used in conjunction with a reduced-calorie diet and exercise regimen. "If someone chooses to use orlistat alone, the drug won't be very effective," says Charles Ganley, director of the FDA's office of nonprescription products.
Alli will arrive in stores this summer and will be priced at around $50 to $60 for a 30-day supply of 90 capsules, according to Steve Burton, vice president for weight control at Glaxo Smith Kline Healthcare, manufacturer of the drug. One capsule is taken before every meal containing fat; the drug works by blocking the absorption of about 25 percent of dietary fat in the gastrointestinal tract.
In clinical trials, the manufacturer found that those who used Alli with diet and exercise lost 50 percent more weight on average than those who used diet and exercise alone. Most users lost about 5 to 10 pounds over six months. The pill won't work for those on very low-fat diets, and may cause severe side effects in those who consume too much fat, due to an excess amount of fat in the stool. The Xenical website acknowledges that users are likely to "experience some changes in bowel habits" which may include "gas with oily discharge, an increased number of bowel movements, an urgent need to have them and an inability to control them." A daily multivitamin is also recommended by the FDA since some fat-soluble vitamins (A, D, E, K, and beta carotene) may not be absorbed. Because of possible drug interactions, Alli shouldn't be taken by people who are on blood-thinning medications, who are being treated for diabetes or thyroid disease, or who have had organ transplants.
Some weight-loss experts worry that people will pin all their hopes on Alli and ignore the need for healthier behavior. And Kelly Brownell, director of the Rudd Center for Food Policy and Obesity at Yale University, says he's concerned that some normal-weight individuals—especially teenage girls—might be tempted to take the drug in an effort to get superskinny. The drug is meant only for adults who are overweight, with a body-mass index over 27.