Alli

From WikiCover

FDA approved, over-the-counter weight loss product from GlaxoSmithKline.

alli, the only FDA-approved weight-loss product available to consumers without a prescription, combines a clinically-proven product with a comprehensive individualized action plan. The alli program encourages modest, gradual weight loss, known by experts as the best way to lose weight.

On February 7, 2007, the FDA approved orlistat capsules as an over-the-counter (OTC) weight loss aid for overweight adults. Orlistat was initially approved in 1999 as a prescription drug to treat obesity, and remains a prescription drug for obesity at a higher dose than the OTC version. OTC orlistat will be manufactured by GlaxoSmithKline under the name Alli and is indicated for use in adults ages 18 years and older along with a reduced-calorie, low-fat diet, and exercise program.

"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes," said Dr. Douglas Throckmorton, Deputy Director for FDA's Center for Drug Evaluation and Research. "OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health."

OTC orlistat is not for people who have problems absorbing food or for those who are not overweight. Orlistat helps produce weight loss by decreasing the intestinal absorption of fat. The 60 mg capsule can be taken up to three times a day with each fat-containing meal. Because of the possible loss of certain nutrients, it is recommended that people using orlistat should also take a multivitamin at bedtime.

The most common side effect of the product is a change in bowel habits, which may include loose stools. Eating a low fat diet will reduce the likelihood of this side effect. Also, people who have had an organ transplant should not take OTC orlistat because of possible drug interactions. In addition, anyone taking blood thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat.

FDA approved OTC orlistat based on the review of the sponsor's safety data and after submitting the product for the consideration by an FDA advisory committee in January 2006. The committee voted in favor of OTC approval.

SK Consumer Healthcare selected alli as the brand name because it conveys the concept of partnership with consumers in their weight-loss efforts. Consumers spend billions of dollars each year on fad diets, unproven miracle pills, and potentially unsafe weight-loss supplements that may not work. alli is the clinically proven option to these hyped, quick-fix products that mislead overweight adults away from weight-loss strategies that are backed by medical science. With alli , consumers have access to an individually tailored online action plan that provides support and the necessary tools to help them lose 50 per cent more weight than with diet alone.

Caroline Apovian, M.D., Director of the Center for Nutrition and Weight Management at BostonMedicalCenterwelcomed the FDA decision. “I applaud the alli program for stressing the importance of a reduced-calorie, low-fat diet in conjunction with a weight-loss medicine proven to be safe and effective. This lines up with research that shows even modest, gradual weight loss provides significant health benefits.” Apovian adds, “More and more people each year - now two-thirds of all American adults - are overweight or obese and still gaining weight.

Desperate to lose this excess weight, people resort to all types of extreme methods that promise everything and deliver no real results. Extremely restrictive diets are unrealistic to maintain, even for a couple of weeks. Dieters end up gaining more weight than they initially lost. It’s time consumers readjust their thinking to realize positive results.”