Xenical Going OTC?

In an extremely strange move, an FDA advisory committee approved the idea of selling the lipase inhibiting drug, Xenical (orlistat) over the counter. Xenical works by blocking fat absorption from the gastrointestinal tract, thereby reducing the amount of dietary fat consumption. The obvious reaction to this would be a reduction in levels of fatty acids (essential and nonessential) being processed in the blood stream and stored as fat. A novel idea, with many flaws.



Olestra

In 1996, Procter and Gamble introduced the artificial fat addictive, Olestra, to the general public. Initial fanfare was good, because it seemed like a sound idea. Olestra is a fat, that's not really a fat. That is, it is similar to most other fats with a sugar backbone, but the main difference is that it can't be absorbed by the body. Here we have a very similar substance that follows the main idea of Xenical. Don't absorb the fat and you won't gain fat. Unfortunately problems emerged very quickly.

The first problem (which is shared with Xenical) is that Olestra caused problems with vitamin absorption. Since many vitamins are fat soluble, Olestra takes up the vitamins and passes them through the GI tract without being absorbed - causing a potential deficiency in certain vitamins. The other, and more commonly known problem with Olestra, was "leakage". When someone consumes lots of fats that are expelled quickly or not absorbed, they have to go some place and they pass through the system very quickly. Olestra became notorious for this and many jokes abounded regarding the synthetic fat's problem with "anal leakage".

Since it's original release, Olestra has been modified to correct most of these problems, and fewer products now use Olestra as its source of fat. Products that use it also supplement with extra vitamins to compensate for the absorption problems Olestra can present when it's being used.

Xenical, on the other hand, has not. Results below show some results of the most common side effects of using Xenical.




As you can see, when one uses Xenical, one can almost expect a result of oily discharge, gas and fecal incontinence due to the fact that the fats are being passed immediately through the system and not absorbed. This is more common with meals high in fat, causing the manufacturer to issue the following guidelines for using the drug:

The patient should be on a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat. The daily intake of fat, carbohydrate, and protein should be distributed over three main meals. If a meal is occasionally missed or contains no fat, the dose of XENICAL can be omitted.

So, exactly what is the point of eating a reduced fat meal when the entire point of Xenical is to reduce absorption of fat from the standard diet? Why not just eat less fatty foods altogether and skip the drug?

In the article, it mentions that the manufacturer would recommend OTC users only use the drug for 6 months. However, benefits after that time period stop and a large percentage of users gain the weight back that they lost.

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.

It's interesting to note that prior to ephedra being banned, Cytodyne, the manufacturer of Xenadrine, came out with a study showing that it's ECA product was more effective than the prescription drug, Xenical - a move that probably pissed off the pharmaceutical industry and could of hypothetically influenced the FDA's decision to ban the herb.

Either way, if I invested in stocks, I would probably invest in underwear if the plans for Xenical go through. There are going to be a lot of people buying new briefs, boxers and panties once the fat dams burst.

CNN.com - Diet pill gets closer to store shelves - Jan 23, 2006