More than half of the U.S. population is overweight. An adult male is considered obese when his weight is 20% or more over the maximum desirable for their height; a woman is considered obese at 25% or more than this maximum weight. Anyone more than 100 pounds overweight is considered morbidly obese.Currently, approximately 65 per cent of US adults are overweight or obese, according to the National Institutes of Health. Research suggests that overweight individuals appear to be on the pathway to obesity.Overweight and obesity are associated with an increased risk of developing health problems such as hypertension, type 2 diabetes and heart disease.
The body cannot store protein or carbohydrates , so excess protein or carbohydrate intake is converted to fat for storage. One pound of fat represents about 3,500 excess calories.Rates of obesity are climbing. An ominous statistic is that the percentage of children and adolescents who are obese has doubled in the last 20 years.Multiple studies have shown that a modest reduction in weight improves health outcomes significantly in overweight or obese patients.
GlaxoSmithKline [NYSE:GSK] Consumer Healthcare announces today that the US Food and Drug Administration (FDA) approved the weight-loss product orlistat 60 mg capsules for over-the-counter (OTC) use in the United States. GSK Consumer Healthcare will market OTC orlistat under the brand name alli ™ (pronounced AL-eye). Approved for use by overweight adults in conjunction with a reduced-calorie, low-fat diet, alli helps people lose 50 per cent more weight than with diet alone. alli is the only FDA-approved weight-loss product available to consumers without a prescription, and it is the first clinically-proven over-the-counter product to be combined with a comprehensive support program.
With alli , we're excited to offer a revolutionary approach to weight loss," says Steven L. Burton, Vice President, Weight Control, GlaxoSmithKline Consumer Healthcare. " alli is more than a pill - it's a comprehensive program that works in conjunction with a sensible diet to increase weight loss. Because weight loss doesn't happen overnight, we're starting to educate consumers now about the importance of realistic expectations, gradual weight loss and lifestyle changes. That's the way to see results, and with alli , we know they can do it."
“There is no magic pill for weight loss and orlistat is not a magic pill. Orlistat is a tool that will help people control their calorie intake and modify their diet.Alli doesn't excuse overweight people from cutting calories and working out."This drug is only going to be effective if it's used in conjunction with a weight loss program -- and what that means is a reduced-fat diet, decreased calories, and an exercise program," said the FDA's Charles Ganley, MD, in a news conference.
"If someone just chooses to use orlistat alone -- without undertaking a weight loss program -- then this drug is not going to be very effective," says Ganley, who directs the FDA's Office of Nonprescription Products.The labeling does state that for every 5 pounds you lose from diet alone, orlistat can help you lose 2-3 pounds more," Ganley says."In studies, most people lost 5-10 pounds over six months," he says.People with a BMI (body mass index) of at least 27 may be the most likely to benefit from alli.If you're markedly overweight -- where your BMI is over 30, for example -- you're likely to have more of a benefit than if it's a lower BMI.The FDA doesn't recommend alli for people younger than 18, but it's not requiring buyers to show ID -- or otherwise restricting sales.
Orlistat helps people lose weight by decreasing the amount of fat their intestines absorb.The 60-milligram capsule can be taken up to three times per day and should be taken with meals that include fat. Taken at meal-time, alli works by blocking about 25 per cent of the fat in the 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.
People taking orlistat may not fully absorb certain fat-soluble nutrients from food, so they should take a multivitamin at bedtime, says the FDA. Over-the-counter orlistat is not for people who have problems absorbing food or for those who are not overweight, states an FDA news release.
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.
Xenical (orlistat 120 mg capsules) will remain available by prescription for those who should be treated under the care of a physician. Xenical will continue to be manufactured and sold by Roche.
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