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Alli: OTC Xenical Gets FDA Approval

alli.jpgThe approval of Alli marks the first government-approved non-prescription diet pill. This new version of Xenical (Orlistat) is a reduced strength version (60mg) that can be sold over the counter.

Dr. Charles Ganley, FDA's director of nonprescription products, stressed that the drug is intended for use along with diet and exercise programs.

The drug will cost between $1 to $2 per day, and GlaxoSmithKline expect that 5-6 million Americans per year will buy the drug.

When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat — about 150 to 200 calories worth — is passed out of the body in stools, which can be loose as a result. About half of patients in trials experienced gastrointestinal side effects.

Read more in Yahoo news, or read previous discussion about this drug.

UPDATE: Alli now available on-line from Drugstore w/free shipping: There are two options: Weight Loss Starter Pack (60 capsules), Weight Loss Starter Pack (90 capsules).
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68 Comments(Now closed for this article)

christina gockel

where to buy this and when?

Reply
Jim

See Updated post above. This will be available in drugstores by summer.

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jonjo

So now you can s*** yourself slim?

Reply
Genn

It sounds like you don't even need to take the pills to lose. You can just follow that booklet/nutrition guide and use the support services or start counting your calories. I think that makes a much bigger difference then the pills.

I would buy it just for the documentation.

I still don't believe a pill can make me slimer.

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Becky J

Be careful of this one. I am a clinical pharmacist and I remember when the original Orlistat came out. The main concern for this drug has been SIGNIFICANT gastrointestinal adverse effcts-specifically oily stools. This is not your run-of-the-mill stomach adverse effects. Please read the fine print on this one or you may be running to the bathroom!
Ceertainly the OTC version is a lower dose so may cause less problems-but this should definately still be a concern!

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Jan

Actually I think that the fact it is OTC will only make people more likely to abuse it. There is a feeling if there is no prescription, then taking a ton can't hurt you, like with the people who took 20x as much ephedra or CLA as prescribed and died. The thinking will be "If 60 mg makes me lose half a pound a week, I'll take 120 mg to lose one pound a week" or worse.

Reply
Debbie

I've also researched the side effects of this one. The gastrointestinal effects may include explosive diarrhea, anal leakage, etc. And I believe they're only talking about the benefit of losing one more pound per MONTH.

I don't think it's worth it.

But I also think it's risky to reduce the absorption of fat-soluble vitamins like A, D, E, K and beta-carotene. You need these vitamins for normal blood clotting among other things.

There's also a risk if you're diabetic or prone to kidney stones or on immunosuppressant drugs. Will these risks be well-publicized enough for people to know this?

I wish they weren't making this an over-the-counter drug. I think they're making a mistake. I agree with Jim's comment, too.

Reply
Debbie

On my previous comment, I meant to say I agree with Jan's comment, too. Sorry.

Reply
FatOne

I took this when it was first available via perscription. You have to take it 30 miniutes
before eating. If you eat a fatty meal, it causes
some gas (no pain for me) and a wet stool.
I wasn't disapplined enough to take it regularly
plus I graze all day, I don't eat 3-4 scheduled meals.
As such, it didn't help me at all. This product is
just a small tool in your tool box, it alone will not
cause an over weight person to reach a healthy weight.
If you treat it like that, it may acutally help you,
however, if you eat high fat meals, you will never
live the lifestyle that causes one to lose weight.
If you eat a low fat meal, then you don't need the stuff anyway. I'm all for mecical science finding
a help for over eating and excess weight etc. As far as I'm concerned, they are not even close to those goals.

Reply
Robin

How do you know it will be summer? Can't we get a hold of this now?

Reply
Cris

Personally, I'm mortified a drug like this is FDA-approved and hits the OTC market. I understand the FDA only approves drugs for "safety" and not impact, but this pill will be marketed as a weight-loss drug, and yet the GSK and FDA both admit it's only a part of a weight-loss program. If you follow the recommended daily allowance of fat consumption, the pill helps block only 180-ish extra calories per day. I don't need to spend $3/day to cut my caloric consumption by 180 calories.

I wrote more about my thoughts on my blog, TheLifeLedger.com.

Reply
Jim
Robin said:
How do you know it will be summer? Can't we get a hold of this now?[...]
The official press release states "available nationwide by Summer 2007".

The thing to watch will be the advertising and marketing. Xenical is already available OTC in countries such as Australia and New Zealand.

What happened in Australia is that the marketing was aimed at young people (they placed a TV ad during Australian Idol). Sales of OTC Xenical instantly spiked with lots of younger teens coming in. It prompted a rant from myself :-) (here).

This will be one to watch closely. GSK will laughing all the way to a very large bank.

Reply
China
Robin said:
How do you know it will be summer? Can't we get a hold of this now?[...]

Who said it would be summer and why will they wait that long? Anyone know where you can get it now? I mean the REAL thing~

Reply
Debi

I'll sh*t myself slim, I don't care. If it works Fabulous! If not...no big deal. I'll pay the money for a tool that will help me out in losing 20lbs, esspecially if it's been proven to actually work!

I'm geeked on this! I can't wait!

Reply
ginger

Another rip-off. GSK just wants to make more and more money.

Reply
MJ

Bring it on. I am going to be one of the first in line. I will wear a diaper or I will sit in the toilet. I am hoping to lose for my son's wedding in june, but it may not be out by then. Wish it were going to be out sooner. I could really use it. I have at least 50 pounds to lose. Please people, wish me luck.

Reply
jeanie

when can you buy this in the store? can you order it on the internet?

Reply
Sam

I will take it, If I have to shit tho get slim so be it. I will buy tucks.

Reply
Crystie

where can I purchase the Alli.....either in the store or internet...please tell me when & where
thanks

Reply
Joe

I think we can all handle a little extra loosened stools in order to lose those extra pounds that will eventually lead to a number of heart problems. Lets try it people, we're a fat nation.......... we obviously need some help!!!

Reply
Jan

Joe, you could also not eat the 180 calories in fat this drug burns. That is just 1 1/2 tbsp of oil, or 1 1/2 oz cheese. Not very hard to remove from one's diet without having to take a drug to poop it out.

Reply
jayden

the only problem i see is, what happens when you stop taking the drug, obvioulsy you cant take it for the rest of your life..do you build up a tolerance? i dont think the loose stools are a problem, i would think that could actually be a benefit for people who suffer from constipation..my biggest concern would be the long term possible side effects..cancer? tumors? or who knows

Reply
jayden

i also wonder, how long does it take to start seeing results?..like i said before the pooing doesnt bother me but if it gives you gas that would suck!!!!!!!

Reply
Becky J

I'm not convinced that the risk is worth it. From: http://www.medicinenet.com/orlistat/article.htm

The most common side effects of orlistat are oily spotting on underwear, flatulence, urgent bowel movements, fatty or oily stools, increased number of bowel movements, abdominal pain or discomfort, and inability to hold back stool (incontinence). Between 1 in 250 and 1 in 70 patients experienced one or more of these symptoms in the first year. Generally, the side effects occurred within three months of starting therapy. In about 50% of patients, the side effects resolved within one to four weeks, but the effects in some patients lasted six months or longer. To reduce the occurrence of these side effects, meals should contain no more than 30% fat because it is the unabsorbed fat that causes most of the symptoms.

Doesn't sound very fun.

Reply
Cris

CNN's Dr. Sanjay Gupta has weight in on Orlistat / alli, and has some interesting cautionary points to make, including:

"How much will you lose? Expect modest weight loss. If you lose 5 pounds through diet and exercise, the FDA says you can expect to lose 2 to 3 more pounds by taking this pill. By the way, the weight loss plateaus after six months."

It just doesn't make sense to spend money and ingest God knows what to mess with my body's internal plumbing in order to lose a couple extra pounds - pounds that I only lose if I make healthy diet changes in addition to taking alli anyway.

Reply
steve owenship

I found some interesting info at www.myalli.com. It sounds like if you control the amount of fat in your diet, you can control the side effects. Watch the videos that they have on the site. There is a big link on the homepage to watch one.

Reply
steve owenship

my link didnt work. http://www.myalli.com

and while we are at it, here is a link to the video -
http://www.myalli.com/HowDoesItWork/Vivilogue/Default.aspx

Reply
Steinn Sigurðarson

This is ridiculous -- a pill that prevents you from digesting fat, and semi-requires you to limit the fat you eat, to control side effects. Ah great, a pill that forces people to go on a low-fat diet, because of all the side effects!

How about people just eat healthier, first by cutting out sugar, then most processed foods, and perhaps MOVE YOUR ASS once in a while. By the way, fats are not just used as fuel in your body, many of them (the unsaturated ones mostly of course) are important metabolites for bodily functions (guys: think testosterone production, yes the hormone that makes you both leaner and more muscular!).

This pill is just a weak excuse to avoid the real problems, processed foods and lack of exercise -- think of the scenario for which your body was designed!

Supplementation is fine, it's just obviously not going to be healthy to eat chemicals which change your normal bodily functions, supplements should help you reach a level of where your nutrient intake matches both on the macro and micro level something closer to that of our hunter-gatherer ancestors.

Reply
Janet

Losing fat is really not THAT hard. It only requires that one keeps a healthy diet (that means eating non fried foods, unprocessed foods, vegetables and fruits, eating enough calories so not to set the body on "starvation mode"), and exercises. It so much safer, healthier, cheaper and *faster* than feeding one's body some odd chemical substances and intoxicating it even further.

For further info on a healthy fat loss I reccomend visiting [URL="http://forums.johnstonefitness.com/showthread.php?t=1222"]this link.[/URL]

Reply
Bob

I ran across your blog and thought I would provide some personal history with Xenical, ALLI's prescription medication. Believe me ALLI will not be abused. The only effect is on fat...not the brain. The only way you abuse this medication is if you take it with a high-fatty diet. I have a great deal of experience with this medication both personally and clinically. I saw many patients who benefited from this medication. Also if you take it with fiber you can cut down on the side-effects. If you have IBS you may experience a longer effect of this medication.

Reply
mermer

I took this drug in prescription form a few years ago. In addition to needing to lose some weight, I was suffering from severe, chronic constipation. After a few months taking Zenical, I dropped 10 resistent pounds and my constipation corrected itself. I only took it one time a day. Taking it 30 minutes before a meal also makes you feel full faster.

Reply
Jan

Bob, people abuse Ex-lax and Ipecac... and they don't have effects on the brain either. So where is the proof in your theory people won't abuse it because it is not psychotropic? We as a society are desperate to lose weight, and that makes many people willing to do anything, no matter how dangerous, to lose weight.

Reply
Dani

I can't wait!! This stuff works great-the only reason I am not taking it right now is because it is cost-prohibitive...For me, it is a behaviorial tool, because it keeps me from eating fatty foods, knowing I will have diarrhea if I do. The pounds melt away with very little change to my diet (except for eating less fat)!
I will buy it the day it goes on sale- and be slimmer and healthier by summer's end!

Reply
lt
China said:
Who said it would be summer and why will they wait that long? Anyone know where you can get it now? I mean the REAL thing~
[...]
Has anyone answered the questions as to when and where it will be available???Reply
Kailash

Fats are not the enemy. Your body needs fats in order to operate. Even saturated fats!

The only bad fats are trans fats, or too many Omega-6 with not enough Omega-3.

You're not going to get skinny crapping out your fat intake, but you just might become hormonally deficient.

Stay away from alli/Orlistat!!

Reply
Dani

Alli will be available sometime in summer 2007- probably through your local pharmacy-
You take a multivitamin-mineral everyday to ensure that you are getting daily requirements. It will be a very useful tool, and our country needs proven help for the obesity problem that plagues so many Americans. I can only speak for myself, but I have seen the results-isn't it about time we had some help, not hype?!
Another bonus- it lowers cholestrol!

Reply
Jan

It is just 180 calories a day. People could just not have the fun-sized candy bar, not super-size the fries they have for lunch, or not have 2 sugars and 2 creamers in their coffee and save the same 180 calories. Why do you think that this is "proven help", Dani, whereas just dieting isn't "proven help"? Also, when vitamins are fat-solluble, when you poop out the fat from your food, you'll poop them out too, so what is the point of taking a vitamin to undo the possible vitamin deficiencies from Alli? You'd need to have them delivered intravenously for it to work.

Reply
Cris

I'm starting to think GSK will advertise alli as a "lifestyle-change pill", marketing alli as one necessary component to a healthy lifestyle centered around weight loss. And if they're smart, they'll start bundling multivitamins along with alli, since people taking alli won't be able to get their fat-soluble vitamins from food. I took a look at their products, and they already sell Geritol, a multivitamin with the fat soluble vitamins A, D, E and K.

So, I'm interested - anyone here planning on taking alli? I've read a couple of quick responses here, but I'm interested in a little more. What are your reasons? Anyone take Xenical previously? What were your experiences? Would you continue taking Xenical, or do you plan on switching to alli now?

I'm so curious that I've set up a poll on my site here: http://www.thelifeledger.com/2007/02/12/poll-will-you-take-a lli/

My readership isn't that high, but I'm just fascinated about this new drug and what people think about it, so feel free to pass the link around - myspace, other forums and boards, email, whatever. You have my eternal gratitude if you get people with opinions to vote and leave comments.

So what do you think - miracle drug, just another fad drug or Worst Drug Ever(tm)?

Reply
Dani

You take the vitamins at a different time of the day than you take the Rx. You only take the Rx at times when you are eating a higher-fat meal. Everyone is entitled to their opinion, ESPECIALLY if they have first hand experience. I am not perfect, I eat healthy most of the time, but am going through menopause so I can use some help with getting the weight off- if you have a problem with that, don't use it, but don't crucify those of us who need it! You haven't walked a mile in my shoes, but you don't even have to try my shoes on. Wear your own shoes, or any that fit, but don't tell me what to put on my feet!

Reply
Dani

P.S. that my last post- I will not let JAN disrespect me or insult me any further. I thought this was a forum that anyone was welcome to contribute to without judgement or lectures.
Sometimes people just want to argue-- I am not one of those people-there is enough intolerance and fighting in this world and life is too short!
FORUM does not mean ARGUMENT!

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