Orlistat was approved as an over-the-counter weight-loss aid by the Food and Drug Administration (FDA) in February. Orlistat has been available for a number of years as the prescription drug Xenical. The over-the-counter version is sold as Alli. Alli contains 60 mg of orlistat, which is half the strength of the prescription product. Orlistat is indicated for weight loss in overweight adults as defined by a BMI of 27 or higher. It is to be used in conjunction with a reduced calorie, low-fat diet and exercise. It is not recommended for people who are not overweight or who have a problem absorbing nutrients.

Alli is available in a starter pack and a refill pack. The starter pack includes detailed patient instructions, a calorie and fat counter, a daily journal, an eating guide, and a carrying case along with 60 capsules of orlistat. People who purchase Alli are encouraged to register with the Alli plan at myalliplan.com. This customized action plan provides feedback progress and guidance on the next steps. It includes an interactive weight-loss tool and on-line journal to help track eating and exercise problems. There are also recipes and meal plans available. Alli can help patients lose more weight than dieting alone, roughly 3 to 5 pounds in six months on average.

Orlistat blocks the absorption of about 25% of dietary fat. Studies seem to indicate that it may be less effective in mildly overweight people than in the obese, but there is no proof of this yet. Orlistat-induced weight loss was associated with slightly favorable changes in blood cholesterol, blood glucose, and blood pressure. The side effects of Alli are similar to those of the prescription product Orlistat. The most common side effects are gastrointestinal. These include gas, oily stools, urgency, diarrhea, and oily spotting. These occur less frequently with the OTC product than with the prescription drug. They can be limited by adhering to a low-fat diet of 15 grams of fat per meal or less. Safety concerns include reduced absorption of fat-soluble vitamins (A, D, E, and K) and drug interactions with cyclosporine and warfarin. Cyclosporine blood levels are reduced and INR is markedly increased by orlistat. Patients are advised to take multiple vitamins containing A, D, E, and K at least 2 hours before or after taking orlistat to avoid deficiencies. Orlistat is not recommended for patients taking cyclosporine or other drugs to reduce organ rejection. Patients taking warfarin or being treated for diabetes or thyroid conditions should consult a physician before taking orlistat and be closely monitored. Alli is not recommended for pregnant or breastfeeding women. People with gallbladder problems, kidney stones, pancreatitis, or severe abdominal pain should consult their physician before taking Alli.

Alli is the only FDA approved OTC weight loss drug. The cost of Alli is about $62.00 per month when taken 3 times daily. In other weight loss news, it is unlikely that the FDA will approve the highly anticipated weight-loss drug rimonabant because of safety concerns. In clinical trials rimonabant was found to nearly double the rate of psychiatric side effects such as depression, anxiety, mood disorder, and insomnia.

Reference: Pharmacist’s Letter detail document #230702, OTC Orlistat (Alli) for Weight Loss: An Update, July 2007.

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