On Tuesday January 24 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.
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.
Article comments
— go to most recent comments1 - Susan Reno-Gilliland
Are you saying you wouldn't find the phrase:
"anal seepage"
hilariously, roll-in-the-floor, funny (as long as it wasn't happening to you)???
2 - Lisa McKay
It would be interesting to track the sales of Depends once Xenical hits the OTC market.
3 - sal m
could anal seepage and oily discharge be one in the same?
if not, susan, you are 1000% correct!
4 - candace
oh www.zug.com theres a uh, interesting "experiment" done with Olestra chips.
5 - Natalie
By the way, I have been using Xenical, under the advice for about 8 months now. The only discomfort I've experience is some bloating and oily discharge.
IF people eat correctly (i-e keep their fat intake below 30%), there is no nasty side effects. You don't have to worry about sitting next to me on the bus.
The problems the author states however are only too true. I can just imagine people popping excess pills or running to KFC and then suffering the consequences.
This drug should be taken as you are being followed by a doctor. Most humans are too stupid to do this on their own.
6 - Susan Reno-Gilliland
Actually, the only reason I made the crass remark was because I have taken the prescription a few years ago and understand the potential side-effects. As the instructions and information provided by the doctor and pharmacist says, as long as you keep the fat intake under 30%, the side effects are minimum to none.
I knew a woman that wasn't taking the Rx but was loading up on the orlistat potato chips and she found -- much to her dismay -- the serious side effect of anal seepage, first-hand.
The problem which may -- which probably -- will occur -- most likely will be over-use (abuse) of the product when it is not regulated by a doctor/pharmacist.
7 - sal m
it's really great to hear from people who are having, or who had, success with the drug.
on the other hand, i think it's a sad commentary that people stop taking the drug because of the side effects rather than change their eating habits, that are causing these side effects to be severe. or won't even take the drug and make an attempt to change their habits.
8 - RJ Elliott
Sell it in France. The human nose won't be able to tell the difference...
9 - Susan Reno-Gilliland
Sal, I never had any problems with the Rx. I found that following the instructions were simple, easy and safe. And, less than 30% fat intake was never a problem for me, so side-effects were never an issue. As I said, it was several years ago and I would recommend the Rx to others, as long as they were willing to follow ALL instructions.
It is the "if one is good, four must be better" attitude that a lot of people have that is the scary thought when there are not restrictions on something like this. I would simply -- STRONGLY -- advise caution with dosage and following all instructions closely to reduce the chances of side effects.
10 - Jake Young
There is a bigger question here. Does the inevitability of misuse constitute a compelling reason to prevent this drug's release to OTC use?
It is my understanding that when making a decision like that the FDA considers whether misuse is fatal or would have lasting consequences. In this case, the side effects, though highly unpleasant and unbelievably ridiculous, are not likely to leave lasting scars to anything other than the self-esteem. Thus, the FDA is justified is releasing this drug.
Also, with respect to the inevitable lawsuits, yes, there could be many. But those lawsuits don't win unless you can prove that the bad thing happened when you used the drug as directed. By being so thorough in the cornucopia of unpleasant side effects, the company is certainly covering its bases.
Then again you could also argue that no one in their right mind would draw further attention to their shame by suing. That would be my way...but then again I don't have anal seepage.
11 - sal m
i don't think the people who will use the drug - and have used the drug - properly shouldn't be able to get this drug because of those people who have/will misuse it.
i have some clients who have used the drug and those who followed the program - as did susan - had minimal if any problems. while those who didn't heed the warning either suffered through pretty nasty side effects or bailed.
i hope i'm wrong about this - and i don't feel the drug shouldn't be approved - but so many people have lost their mind when it comes to weightloss.
12 - Sandy
When is the drug going to be available without a prescription? I have ordered the blue pill online at a hefty price. I have had no side effects. I am a female who doesn't have regular (weekly) bowel movements. I have also followed the recommended diet plan.
13 - sal m
the FDA's advisory panel recommended that orlistat/xenical be made available without a prescription back in january, but i haven't seen any news with regards to the FDA making this official.
14 - laura
but does taking more pills make you actually lose more weight?
15 - sal m
are you serious?
not following the directions to the letter will result in you soiling yourself...thanks for proving my point.
16 - laura
anytime...but the thing is...i´ve been using it for 2 weeks ..and gotten 0 results!...xenical was my last hope of losing those last 10 pounds......do you know of any other diet pills that work?
17 - laura
come on...please help me!
18 - sal m
i don't give advice with regards to any kind of meds...check with your doctor...
19 - laura
ok....but i´d still like to know..if you do or dont lose MORE weight if you take more pills .i know you soil yourself..that its disgusting and that it stinks like hell..but i dont care...can u answer this...... and i wont bother u again.,, :)
20 - cindy
I think if its going to be an otc then it needs to be sold from behind the counter to 18 and older like a lot of otc drugs are now days.