FDA Approves Orlistat for Over-the-Counter Use

The Food and Drug Administration (FDA) today 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.

Source:  FDA.gov

FDA Approves Orlistat for Obesity

The Food and Drug Administration has approved orlistat, a new drug to treat obesity. Orlistat is the first drug in a new class of non-systemically acting anti-obesity drugs known as lipase inhibitors.

Unlike other obesity drugs, orlitstat prevents enzymes in the gastrointestinal tract from breaking down dietary fats into smaller molecules that can be absorbed by the body. Absorption of fat is decreased by about 30 percent. Since undigested triglycerides are not absorbed, the reduced caloric intake may have a positive effect on weight control.

The effects of orlistat on weight loss, weight maintenance, and weight regain and on a number of obesity-related illnesses were assessed in seven long-term multicenter, clinical trials. These studies included about 2800 patients treated with orlistat and 1400 patients treated with placebo. A well-balanced, reduced- calorie diet was recommended for all patient in the weight-loss and weight-maintenance study periods. The diet was intended to decrease caloric intake by 20 percent and to provide 30 percent of calories from fat. In addition, all patients were offered nutritional counseling.

Of the patients who completed one year of treatment, 57 percent of the patients treated with orlistat and 31 percent of the placebo-treated patients lost at least 5 percent of their baseline body weight.

The recommended dose of orlistat is one capsule with each main meal that includes fat. During treatment, the patient should be on a nutritionally balanced, reduced-calorie diet that contains no more than 30 percent of calories from fat. Orlistat is indicated for obese patients with a body mass index (BMI, a measure of weight in relation to height), of 30 or more, or for patients with a BMI of 27 or more who also have high blood pressure, high cholesterol, or diabetes. A person who is 5’5” in height and weighs 180 pounds would have a BMI of 30.

Because orlistat reduces the absorption of some fat-soluble vitamins and beta carotene, patients should take a supplement that contains fat soluble (A, D, E, and K) vitamins and beta carotene. The most common side effects of orlistat are oily spotting, gas with discharge, fecal urgency, fatty/oily stools and frequent bowel movements.

Orlistat is manufactured by Roche Laboratories Inc. under the trade name Xenical.

Source:  FDA.gov