First Over-The-Counter Diet Pill Gets OK

FDA Approves Nonprescription Sales Of Fat-Blocking Pill Orlistat

(CBS/AP)  Dieters got a new tool Wednesday to help them take off the extra pounds — the first government-approved nonprescription diet pill.

The Food and Drug Administration said the fat-blocking weight-loss pill orlistat, which has been available by prescription, can be sold in a reduced-strength version over the counter.

The new version will be sold as "alli" by GlaxoSmithKline PLC. Xenical, the prescription version, is made by Roche Holding AG.

GlaxoSmithKline chose the name "alli" because it's supposed to be "allied" with a weight-loss program, including exercise and healthy eating, reports CBS News correspondent Dan Raviv.

The drug is intended for people 18 and older to use along with a reduced-calorie, low-fat diet and exercise.

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

"Using this drug alone is unlikely to be beneficial," Ganley said at a telebriefing.

While some dietary supplements make weight-loss claims, Ganley said this is the first nonprescription drug approved by the agency for that purpose.

Ganley said in trials, for every five pounds people lost through diet and exercise, those using orlistat lost an additional two to three pounds.

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.

The agency recommended users take a multivitamin when using this drug.

The new drug would contain half the dose of Xenical prescription capsules. The price has not been set but is expected to run $1 to $2 a day, company officials said. The company estimated 5 million to 6 million Americans a year would buy the drug over the counter.

The Food and Drug Administration said the most common side effect of the product is a change in bowel habits including loose stool and some oily spotting. Eating a low-fat diet will reduce the likelihood of this side effect.

FDA said people who have had organ transplants should not take OTC orlistat because of possible drug interactions. In addition, anyone taking blood-thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat, the agency said.

GSK Consumer Healthcare, which will market the pill, said it chose the name alli to indicate a partnership with consumers in their weight-loss efforts.

"We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes," said Dr. Douglas Throckmorton, deputy director for the FDA's Center for Drug Evaluation and Research.

"OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health," he said.

But Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group, called the approval "the height of recklessness." Wolfe said studies have associated the prescription version of the drug with precancerous lesions of the colon. He has also called for withdrawal of the prescription version.

[dietanatrim]

..Since loosing more than 40 pounds thanks to Anatrim. , my *** life is back on track, better than before even...
[read more]

Rod B., Atlanta
[url=http://www.dietanatrim.bravehost.com/diet_loss_weight.html]diet loss weight[/url]

..I was so amazed I decided to start exercising and getting outside more and I even starting eating better...
[read more]

Steve Richter, Texas
# [url=http://www.dietanatrim.bravehost.com/diet_loss_pill_weight.html]diet loss pill weight[/url]


..I was originally amazed that the first two pills I took of Anatrim, almost immediately took my cravings away...
[read more]

Linda C., Bellevue WA
# [url=http://www.dietanatrim.bravehost.com/diet_plan.html]diet plan[/url]

a target=_blank href=http://www.dietanatrim.bravehost.com lose weight, To grow thin, diet management manual owner waist, diet pill, beach diet south, a

[sy2502]

I have a friend who used the prescription version of this pill, and heard the horror stories about what the article politely calls "gastrointestinal side effects". What it boils dows it that 150 to 200 calories in each meal get passed by your bowels instead of being absorbed by the body. How about just cutting the size of your meal by 150 or 200 calories, and avoiding the side effects altogether?

[drinuk]

Do not believe anything Big Pharma tells you, this is yet one more get rich quick pill for them !! You stay fat with side effects they get fatter and laugh all the way to the bank with the FDA waiting in line for their handout too, they are as crooked as a two dollar note.

[lonestartnow]

If people changed their behavior to begin with they wouldn't need a "magic diet pill." Healthy nutritional choices, finding ways to become more physically active (even if you don't go to a gym) and reducing your saturated fats, trans fats, sugar and intake of refined carbs will result in weight loss--and a healthy lifestyle. Add finding ways to put your body in motion, and you're on the way to long-term success--without the supplements and expense of supplements.

How many people are looking for a magic pill because they don't do this to begin with? This is just one more example. Don't people realize taking weight loss supplements isn't the same thing as making healthy choices? It's exactly the opposite, and considering the side effects, makes no sense at all for the consumer. For the drug company, that's a different story.

[legendary240]

Neat! This one won't give you a heart attack. It will just turn your colon into a lead pipe and then all the calories just flow right through. Of course it will turn your eyes pink and make you hair white, but that beats walking, exercizing and eating healthy. The miracles of science never cease!

[jetlizhan]

to really lose weight, you just have to eat healthy, stay away from fast foods, and like it or not you MUST exercise -IF YOU DON'T MOVE IT, YOU WON'T LOSE IT!!!!!!

[seanv137]

If you really want to lose weight fast naturally for the same price, take the free form amino acid L-Carnitine before you work out with a glass of water. You'll burn fat so fast it will make your head will spin. You can get it at any health food store.

[tinypig]

If you go and look at their website, www.myalli.com they are very honest about what this product is all about.

Note a few of these quotes -
"it won%u2019t be easy, nothing worth it ever is." from the homepage. They realize that it takes hardwork to lose weight, this product is a partner and not just a cure-all. You have to do your part and the pill will help with losing more weight.

They are even more honest on the "What is alli?" page -
"First, alli is not a miracle pill or a quick fix. Lots of other weight loss products promise results overnight. But alli is based on good things like hard work, smart choices, and gradual weight loss. Second, alli is a unique combination of a pill and a plan to help you lose even more weight than dieting alone. If you could lose 10 pounds through dieting alone, you could lose 15 with alli.

But alli only works if you work. And individual results may vary."


Is is worth losing 5 more pounds? Maybe for some.

[momnique]

I agree with you talk2kim67. They stress the importance of diet and exercise along with the pill. What a bunch of hooey again. Drug companies getting rich by preying on the ignorance of people. People need to stop eating more calories than they burn, get off their fat ***** and get moving. The only magic bullet against obesity is to adopt a healthy lifestyle, i.e., proper eating (no junk foods,) and exercise. The only thing that happens when drugs like that come out is that people rely on them to lose weight, so they eat more and end up getting fatter. Sadly, discipline is not sold on shelves.

[fredhetz]

I have used the prescription version of this med. It is helpful but is by no means a magic bullet. Because it siphons off dietary fat, you take in fewer calories from the food you eat. But you still have to mind what you eat and this med's success is contingent on a multifaceted approach to weight loss. Whether or not it's worth it for you is something you have to figure out -- but it can be a good tool.

[rray52]

"About half of patients in trials experienced gastrointestinal side effects."

The images in my head will not stop.
A whole new meaning to %u201Cgotta go gotta go gotta go%u201D
I wonder if GSK owns a toilet paper or adult diaper co. Talk about creating a demand for your product.
Thousands of people running for the toilet, better build more rest stops on the highways

I%u2019m sorry no more potty humor

[talk2kim67]

It doesn't work unless it is accompanied by diet and exercise--So are you really losing weight from the pills--or changing your diet and working out? If you are losing any weight at all--it's because you are crapping it out! Water weight! You may as well take a laxative instead and save yourself some money! It's just a money scam like all the rest, and I'm sorry but who really wants "oily stains?" EWWWWWWWWW!!!!!!

[rray52]

"About half of patients in trials experienced gastrointestinal side effects."


What might the common name for that be?

I%u2019m sorry folks but I can%u2019t help my self, here goes the first pun.

Alli-oops.

[reel-crazy]

The only reason this got FDA approval was because of a powerhouse company like GSK getting it rammed through the system.

Cel-Sci (CVM) has an anti-cancer drug that will continue to be placed on the back burners and require more lengthy clinical trials unless a company like Pfizer, GSK, Merck, King, or Astra Zeneca gets a hold of them.

What's more important here...a diet pill or a cancer cure?