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Prescription Diet Pill Xenical Offered OTC?

Pharmacies have been selling orlistat, a fat-blocking diet pill, since 1999 under the brand name Xenical. Made by Roche, this prescription diet pill has been used by more than 22 million people worldwide. Now GlaxoSmithKline is seeking FDA approval to manufacture and market an over-the-counter (OTC) version of orlistat under the brand name Alli (pronounced “ally”).

In January 2006 federal health advisors voted to recommend FDA approval of the new weight loss pill Alli. Although the approval process may take months, the FDA typically follows the recommendations of advisory committees. If approved by the FDA, it will mark the first time weight watchers can legally add the diet drug orlistat to their weight loss program without a prescription.

Pharmaceutical industry observers expect the FDA to approve OTC sales of Alli, but not everyone is convinced that they should.

Health and fitness experts are concerned that Alli isn’t right for the average consumer. Tracie Johanson, a health club owner in Nampa, ID agrees with that assessment: “People looking for fast weight loss will be disappointed if they rely on a fat loss supplement like Alli. Orlistat and other diet products are never the answer to lifelong fitness. We like to see our gym members maintain their weight with a healthy diet and exercise rather than a diet supplement.”

Unfortunately, many Americans seeking honest weight loss information will purchase Alli and add it to their diet plan without having any knowledge of the potential problems presented. “The company estimated 5 million to 6 million Americans a year would buy the drug over the counter. Those numbers could mean at least $1.5 billion a year in retail sales” (Source: CNN; Tuesday, January 24, 2006).

The potential problems associated with this weight loss product are numerous and daunting:

Results Are Mediocre At Best:

Consumer looking for quick weight loss results may be shocked to find that Alli cannot deliver those results. “In six-month clinical trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills” (Source: MSNBC; January 24, 2006). Losing just five to six pounds in six months is hardly a weight loss success story worth bragging about.

Users Will Gain Weight After They Quit Taking Alli:

Buyers tempted to add Alli to their diet program on the assumption that some weight loss is better than none will be annoyed to learn that any weight lost with Alli is not likely to be permanent. “‘The pill’s effect ends once its use is stopped’, said Dr. Julie Golden, a medical officer in the FDA’s division of metabolism and endocrinology products. ‘A previous study showed a progressive weight gain in patients after they stopped using orlistat,’ Golden said” (Source:; Tuesday, January 24, 2006). In other words, in order to maintain the minimal weight loss they’ve achieved, the consumer will need to keep using Alli forever. Not only would this solution be expensive, but it is also discouraged by the manufacturer of Alli (GlaxoSmithKline).

Weight Loss Drug Alli Is Not A Long Term Answer To Obesity:

With approximately two-thirds of the population overweight, customers in America want a weight loss plan they can stick with for life. Alli is not the answer, at least according to the maker: “Glaxo wants people to use it for only six months at a time, but as an over-the-counter item, its use would not be policed” (Source: MSNBC; January 24, 2006).

Alli Is An Expensive Way To Achieve Moderate Fat Loss:

While consumers pursuing easy weight loss will often pay more than they can afford to solve their weight issues, many will find the relatively high retail price of Alli prohibitive. The average consumer will pay $12 to $25 per week for product, much more than the average $29 monthly price for a gym membership. At prices ranging up to $100 per month, Alli is not a cheap diet pill at all.

Alli Effective Only When Combined With Diet And Exercise:

Doctors and medical experts have long held that the best weight loss program is regular exercise, a point validated by the manufacturers of Alli. “Glaxo said the drug helps the overweight slim down only when combined with a diet and exercise regimen. The drug’s actual effect on weight loss is ‘gradual and modest,’ said Steve Burton, Glaxo’s vice president of weight control” (Source: CNN; Tuesday, January 24, 2006).

Alli Contains Only ½ The Potency Found In The Prescription Product:

Another reason why Alli may not help users lose weight fast is that it would contain just a half dosage of the active ingredient orlistat when compared to the prescription capsule. Half the dosage means half the results, which may not lead to the weight control success users are hoping for.

Alli Blocks Only 150 to 200 Calories:

Consumers seeking a weight loss supplement that will allow them to eat whatever they want and still drop the pounds will be displeased with Alli. “When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed…..the equivalent of about 150 to 200 calories” (Source: MSNBC; January 24, 2006). Since there are 3,500 calories in a single pound of fat, Alli users can expect to lose one pound of body fat every 23 days assuming a constant diet and level of activity. Using the retail price estimates provided by GlaxoSmithKline, this translates into an investment of approximately $75 for each pound of fat lost, a hefty investment by any standard.

Vitamin Deficiency A Risk For Alli Consumers:

Although Alli may help some users lower their body fat percentage by a few points, the orlistat that prevents some fat from being absorbed into the body also prevents some vitamins from being metabolized. “Half of the patients enrolled in trials of the drug failed to understand labeling directions that they should take supplemental vitamins at least two hours before or after using the pills” (Source: CNN; Monday, January 23, 2006). Consumers are cautioned to take vitamin supplements two hours before or after using Alli, but with fifty percent of patients in the trial failing to follow these instructions it’s difficult to imagine that Alli is the healthy weight loss answer for most people.

Alli Could Cause Further Complications For Special Populations:

Purchasers looking for rapid weight loss may find themselves unable to use Alli if they have had an organ transplant surgery or are on the medication warfarin. “The drug also could cause problems for organ transplant patients taking the drug cyclosporine as well as those on warfarin, a blood thinner. The drug’s label would warn such patients against taking the weight loss pill” (Source: MSNBC; January 24, 2006).

Serious Side Effects Frustrate Alli Users:

Diarrhea, gas, incontinence and oily spotting are among the Alli side effects listed by GlaxoSmithKline. Unintended consequences such as these may hamper the lifestyle of the Alli customer, making this weight loss diet pill less than appealing. “After taking this pill you may have urgent needs to run to the bathroom, oily and uncontrollable diarrhea – all for the sake of avoiding 150-200 extra calories a day” (Source: Bedros Keuilian).

Alli Users Still Miss The Benefits Of Regular Exercise:

Even those customers who do find it possible to attain their ideal weight using Alli alone will still be passing up the multiple advantages of regular exercise. Because prescription weight loss pills don’t actually cause the body to work, they will never be able to impart the same benefits as exercise. Only consistent exercise has been proven to help the user lose fat while at the same time lowering cholesterol, lowering blood pressure, strengthening bones, etc.

Weight loss medications like Alli are not the best weight management solution because simply losing weight, while healthier than being obese, will not give us all the benefits of exercise. So even if Alli worked perfectly for all users without any side effects, it would still be inferior to achieving our health and fitness goals with exercise.

Consumers seeking weight loss tips and accurate diet information would do well to stop looking for the best diet pill and start a weight loss exercise program. The greatest fat loss supplement is still regular exercise, and no rapid weight loss pill will change that.

Tracie Johanson is the founder of Pick Up The Pace, a 30-minute exercise studio for women focusing on fitness, health and nutrition for maximum weight loss. Please visit for more information.