Over-the-Counter Xenical

The prescription diet pill, Xenical, also known as Orlistat, will soon be available as a non-prescription, over-the-counter (OTC) Xenical version. Is this the magic pill the weight loss world has been waiting for? According to the makers of the OTC variety, only with proper diet and exercise can the "magic" happen.

What is Xenical?

Xenical is a weight loss drug approved in 1999 that works in the intestinal tract by blocking a portion of the fat consumed in a typical meal. The estimated amount of blocked fat in a meal is about 25%, and consumers are advised to eat meals with no more than approximately 15 grams of fat. With Alli, this percentage of fat is not broken down and absorbed which results in less overall calories absorbed by the body. With fewer calories offered to the body, potential weight loss can follow. This is an effective method for obese individuals due to the high risk factors for several health conditions associated with overweight status, including diabetes, cardiovascular disease, and high blood pressure.

How is Over-the-Counter Xenical Different?

The OTC pill, which will be sold on store shelves under the name Alli, is a 60 milligram dose instead of the prescription dosage of 120 milligrams. The Federal Drug Administration (FDA) approved the OTC version for sale of the pill to begin in the summer of 2007. As far as the mechanism of action for weight loss, Alli works as a fat-blocker in the same way as the prescription drug. The entire Alli package will include a lengthy guidebook with meal plans, eating out suggestions, fat and calorie counters, and daily food journals. The instructional book strongly emphasizes the need to follow a low fat diet and engage in physical exercise in order for the drug to work successfully toward weight loss. Furthermore, consumers have access to myalli.com, an interactive website for tracking, comments, and additional information.

Directions for Use

One capsule is to be taken with each meal, up to three per day. A relatively low fat diet is a principle criterion for using the drug. More specifically, up to 30% of calories can be derived from fat. The manufacturers make it clear that eating a high fat diet while taking the pill can cause extremely uncomfortable side effects. Plus, weight loss will not occur unless a reduced calorie and fat diet is part of the diet program, as well as daily physical activity. Furthermore, this version of Xenical is intended for use for only a six month time period, after which healthy diet and proper exercise regimes must continue in order to maintain weight loss. Finally, because the action of the drug blocks fat, the absorption of some vitamins is also inhibited. These include the fat-soluble vitamins: A, D, E and K. For this reason, a multivitamin is highly recommended to ensure optimal capacity to absorb these nutrients.

Does It Work?

In clinical trials, participants lost an average of 50% more weight than those taking a placebo. While this is only a modest weight loss amount, the importance of losing 5 to 10% of body weight for some is extremely beneficial for improving health and preventing life-threatening illnesses. Studies also showed that individuals taking the 60 milligram dose of over-the-counter Xenical resulted in 85% of weight loss of the higher prescription dose. An example of a positive result would be a person who lost twenty pounds with diet and exercise will be able to experience 10 additional pounds of weight loss by taking the pill as directed. Similarly, a person losing 5 pounds with lifestyle changes can expect an additional 2.5 pound weight loss with Alli.

Side Effects and Health Warnings

As with all drugs, whether prescription or not, there are potential side effects. Over-the-counter Xenical is not excluded and include diarrhea, cramping, and flatulence. Persons who have gallbladder problems, digestive complications, kidney or liver problems are not advised to take Alli. Diabetes must closely monitor glucose levels as Alli can affect the management of blood sugars. Pregnant women, breast-feeding mothers, and children under 18 years of age are not to take the OTC drug. There is much concern that the drug will be abused and is of particular concern with persons suffering with eating disorders. The FDA, along with GlaxoSmithKline, plan on monitoring the drug use closely due to these concerns. It is strongly recommended that any person considering the usage of Alli when it becomes available to discuss the plan with a medical doctor.

Cost

This is not a cheap way to lose weight by any means. A 5 pound weight loss could end up costing nearly $300 according to one report. Ninety capsules will set you back about $55 at the time of this writing. In addition, because it does not require a written prescription from a medical doctor, insurance is unlikely to cover any of the cost.

Summary

It is somewhat reassuring to know that the FDA has closely studied the over-the-counter Xenical drug and deemed it safe for public use. This is the first FDA-approved weight loss pill available without a prescription, an enormous step away from the serious dangers of other supplements marketed as weight loss enhancers such as ephedra, hoodia, and phentermine. However, time will tell whether or not the public will responsibly use the drug or abuse it.