Xenical Closer To Attaining OTC Status

On Tuesday January 24, 2006 federal health advisors to the Food and Drug Administration (FDA) voted to recommend that Xenical - a drug prescribed for weight loss - be made available to the public in an over-the-counter dose. Final approval still has to be given by the FDA before GlaxoSmithKline can sell this non-prescription version.

Over a year later, we're thisclose to seeing Xenical available in an over-the-counter dose.

For those of you who may not be familiar with Xenical (generically know as orlistat), this is a drug that blocks the absorption of fat into the bloodstream, therefore reducing the amount of calories a person gets from a meal. The prescription dosage of Xenical decreases the amount of fat by about one-third and, when combined with a low-calorie diet and exercise, can help promote weight loss. The benefits delivered by Xenical stop as soon as you stop taking the drug.

Approved by the FDA in 1999, this drug hasn't been as popular as anticipated, in large part because of a wide range of gastrointestinal side-effects, most of which are extremely unpleasant, even though they are not dangerous. Well maybe dangerous to your clothing or people in close proximity, but I'll get to that in a moment.

Here is the list of side-effects - and it's a doozy - that you could encounter during your first year on Xenical: abdominal discomfort or pain, anxiety, arthritis, back pain, diarrhea, dizziness, earache, fatigue, fatty or oily stools, fecal urgency or incontinence, flu, gas with fecal discharge, gum problems, headache, increased defecation, menstrual problems, muscle pain, nausea, oily discharge, rectal discomfort or pain, respiratory tract infections, skin rash, sleep problems, tooth problems, urinary tract infections, vaginal inflammation, vomiting.

There's more, as depression, leg pain, swollen feet and tendonitis are side-effects that can crop up after one year of usage. By the way, my bookie can tell you that if you're always soiling yourself, of course you are going to be depressed.

Now my point is not that somehow this drug is dangerous or shouldn't be approved for over-the-counter sale. But I am saying - warning - that given the nature of what this drug is used for and knowing human nature, this is a drug that has a very high likelihood of being misused and abused. And the resulting shit storm - pun intended - will be quite severe.

And I want to be quite clear on this...I am blaming - in advance - the people who will misuse the drug and NOT the companies that develop, produce and market this drug. I have no faith in my fellow man when it comes to this kind of thing.

For it is obvious that if used correctly - and that's a big "IF" considering that we're talking about a weight loss drug - Xenical is safe and effective. But the potential for abuse here is tremendous. As is the potential for soiled garments of all kinds.

The prescription dosage of Xenical is one 120-milligram capsule three times per day with each meal containing fat. The proposed over-the-counter dose of Xenical - called Alli - is a 60-milligram capsule. So do the math and a person could very easily take the prescription level of Xenical by doubling up on the Alli. I don't think that's too much of a problem.

The problems will come when people give in to the inevitable "more is better" philosophy that too often comes into play. These problems will be compounded when people figure that they can double up on that dosage and be able to go on a KFC binge. The term "the Alli Shuffle" will take on a whole new meaning as a result of the misuse of this orlistat stuff.

And anyone who doesn't think that this will happen hasn't been paying too much attention to their fellow beings.

By looking at the information with regards to side-effects - anecdotal and otherwise - it's clear that the most common side effects are the good old fatty/oily stools, gas with fecal discharge, fecal urgency, increased defecation and oily discharge. And just for the record, I know the fourteen-year-old that resides deep inside all of us - and that goes for you girls out there as well - is laughing his/her ass at the comedic possibilities that spring to mind. Actually, my inner fourteen-year-old is dangerously close to the surface ... but I digress.

These symptoms - ladies and gentlemen - represent a veritable Hiroshima of eliminative horrors, and it's no wonder that sales for this drug are in the crapper. But seriously folks, who wants to be sitting on the subway next to an anxious, dizzy person who is suffering from gas with fecal discharge and the concomitant fecal urgency? It's no wonder that people using Xenical are anxious. They know that they may "you-know-what" at any moment, and that any "knock at the backdoor" could turn ugly in a hurry. "Hey Bill, you look anxious today. What gives?"

Ok, I've veered perilously close to the dark side of silliness so - in closing - I will now attempt to regain a modicum of credibility by veering back towards the light of seriousness.

After being approved for over-the-counter sale, Xenical will go on to become one of the most misused and abused drugs ever sold to the American public. And while dry cleaners and purveyors of undergarments and associated "foul weather gear" may rejoice in the newfound need for these goods and services, there will be a lot of unhappy Alli users out there. Lawsuits will follow.

And I'll be here making sophomoric jokes while saying, "I told you so!"