The launch of Alli (Orlistat) the first FDA-approved over-the-counter anti-obesity drug - is exciting news for millions of obese and seriously overweight Americans. Alli, which is expected to hit drugstore shelves this summer, is comprised of a reduced-strength formula of the popular weight-loss drug Xenical (orlistat) and is the only weight-loss drug endorsed by the U.S. Food and Drug Administration and made available without a prescription. Pharmaceutical giant and Alli manufacturer GlaxoSmithKline maintains the product rights to Alli through mutual agreement with Roche, the manufacturer of prescription-only Xenical. Xenical has a steady safety record and has proven to be moderately effective in helping obese individuals lose weight. Studies indicate that when patients take prescription Xenical in combination with a weight-loss program, patients lost an average of 12.4 pounds of weight less in six months -- about double the amount lost by patients taking a placebo weight loss drug. Some studies have suggested that Alli, at half the dosage (and approximately one-third the price of prescription Xenical,) is almost as effective. How it Works Alli is made of the same chemical structure as Xenical. The drug obstructs dietary fat from being absorbed by the body after food consumption. The undigested fat is then removed from the body as bowel waste. As such, the drug it leads to a reduction in the absorption of fat by as much as 30%. Alli will be available in 60 milligram capsules, to be taken three times a day with meals that contain fat. Officials at GlaxoSmithKline said that the drug works by "blocking about 25 percent of the fat in food a person eats. Because of the way it works, Alli must be used in conjunction with a reduced-calorie, low-fat diet containing about 15 grams of fat per meal." GlaxoSmithKline also reported that the drug helps people lose 50 percent more weight than dieting alone. Alli will cost consumers $12 to $25 a week. "This is the only FDA-approved, over-the-counter weight-loss drug product," Dr. Charles J. Ganley, the FDA's director of the Division of Over-The-Counter Drug Products, said during a teleconference. "There are some products, primarily dietary supplements, that make weight-loss claims and those are not FDA-approved, although they are permitted to make these claims." Alli vs. The U.S. Obesity Epidemic The FDA's approval of the first over-the-counter drug for weight loss comes as the United States and other Western nations are struggling with an unprecedented obesity epidemic. According to the U.S. National Center for Health Statistics, 30 percent of American adults 20 years of age and older -- more than 60 million people -- are obese. An Additional 36 percent of Americans are considered overweight. But is Alli the magic diet pill that dieters have been asking for? Maybe not, according to some researchers. Dr. Raj Padwal, an assistant professor of general internal medicine at the University of Alberta, is unsure of about the efficacy of the drug. People may only lose 1 to 2 kilograms (2.2 to 4.4 pounds) on this half-strength dose [of Xenical]. Whether that is worthwhile is questionable," said Padwal. The occasional patient may benefit, but many patients may not. For those patients who need extra incentive to adhere to a low-fat diet, the drug may help." Alli is likely to cause very limited direct harm, but may also cause limited good, according to Dr. David L. Katz, an associate professor of public health and director of the Prevention Research Center at the Yale University School of Medicine. "[Alli] is a relatively ineffective weight-loss aid," he said. "If availability of the drug distracts people from the tried-and-true approach to weight control - eating well and being active - then the FDA decision could prove more harmful than helpful, in spite of good intentions." Side Effects According to research and trials, Alli has very few negative side effects. However, users be warned: eating a meal with too much fat while taking the drug can result in bowel changes such as loose stools, according to the FDA. Side effects typically occur in the first weeks of treatment and can be managed by following the recommended diet of about 15 grams of fat per meal, GlaxoSmithKline said. It is also recommended that users take a multivitamin once a day at bedtime because the drug can interfere with the absorption of some vitamins. Other side effects may include: Oily skin spotting Gas with discharge Fecal urgency Fatty or oily stools Frequent bowel movements Before Taking Alli Prior consultation with a doctor is recommended before taking Alli. Be sure to: Tell your doctor or pharmacist if you are allergic to orlistat or any other drugs. Tell your doctor or pharmacist what prescription and nonprescription drugs you are taking, especially anticoagulants (''blood thinners'') such as warfarin (Coumadin); medications for diabetes, such as glipizide (Glucotrol), glyburide (DiaBeta, Dynase, Micronase), metformin (Glucophage), and insulin; other medications for weight loss; pravastatin (Pravachol); vitamins such as beta-carotene and vitamins A, E, and K; and herbal products. If you are taking cyclosporine (Neoral, Sandimmune), take it 2 hours before or 2 hours after orlistat. Tell your doctor if you have or have ever had anorexia nervosa or bulimia, gallstones, thyroid disease, diabetes, kidney problems, or if you consistently have problems absorbing food (malabsorption syndrome). Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Inform your doctor about your medical history including drug or alcohol abuse in order to avert any medical mishap. Also, people who have had an organ transplant should not take the Alli. Anyone taking blood-thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using the drug, the FDA said. Is Alli the end-all treatment that will fight the obesity epidemic once and for all? Studies indicate that it may certainly help, yet skeptics are equally as weary about its overall effectiveness. If you are considering taking Alli when it hits the shelves this summer, be sure to consult with your physician first.
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