FDA may make first weight-loss pill available over the counter WASHINGTON (AP) — A prescription diet drug that blocks the absorption of fat is "no magic pill" but will nevertheless help control calorie intake, the drug manufacturer said Monday as the Food and Drug Administration considered whether to approve the pill for over-the-counter sales.
In 1999, the regulatory agency approved orlistat, marketed as Xenical, for sale as a prescription drug. The drug blocks the absorption of fat the first weight-loss drug it has approved for over-the-counter sales.
Now, GlaxoSmithKline Consumer health care seeks to sell an over-the-counter version of the pill.
"There is no magic pill for weight loss and orlistat is not a magic pill. Orlistat is a tool that will help people control their calorie intake and modify their diet," said John Dent, the pharmaceutical company's senior vice president of research and development.
That proposed version, called Alli (pronounced "ally"), would contain half the dose of the prescription capsule. Two FDA advisory committees were to vote on recommending approval late Monday.
The agency usually follows the non-binding recommendations of its outside panels of experts.
An earlier, internal FDA review found the drug is a "safe and effective weight loss agent," but held off on concluding whether it should be sold without a prescription. The review found that over-the-counter use of the drug could lead to vitamin deficiencies and encourage abuse.
On Monday, FDA panel members questioned whether consumers would be able to distinguish Alli from non-approved dietary supplements also sold as weight-loss aids. They also expressed concern about its effect on vitamin intake.
When taken with meals, the drug blocks the absorption of about one-quarter of any fat consumed. That fat is passed out of the body in stools, which can be loose or oily as a result. Other side effects include gas, incontinence and oily spotting. About half of patients in trials experienced such side effects, the company said.
In six-month clinical trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills, according to FDA documents. The drug's effect on weight loss is "gradual and modest," said Steve Burton, Glaxo's vice president of weight control.
The primary concern of FDA reviewers was the drug's potential to create vitamin deficiencies, since its use also blocks absorption of fat-soluble vitamins like D, E, K and beta-carotene. The company has recommended patients take multivitamins when using the drug.
However, at least 47% of people ignored that advice in drug trials. Furthermore, just 35% of diabetes patients in a study correctly stated the drug was inappropriate for them, according to FDA documents.
Those sort of results worried FDA reviewers, who questioned the risk of selling the drug directly to consumers "without the principal involvement of a learned intermediary," or prescribing doctor.
The reviewers also showed concern about the increased potential for abuse or misuse of a prescription-free version of the drug, especially among bulimics or binge-eaters who could develop vitamin deficiencies due to chronic use. The company said there was a "very low" potential for abuse.
British-owned GlaxoSmithKline's U.S. operations are based in Philadelphia and Research Triangle Park, N.C.

Thank God for the FDA! I was hoping to find an approved way to die of malnutrition!

best weight loss protuct is "put the cookie down hcl"

funny thing is:

In a few years, you can market an empty bottle with that on the label..... and the FDA will bust in and shut down your factory.

FDA Rep ---->

Those sort of results worried FDA reviewers, who questioned the risk of selling the drug directly to consumers "without the principal involvement of a learned intermediary," or prescribing doctor.

yea but cigarettes, alcohol, ice cream and tylenol are sold over the counter without a learned intermediary, and people don't die from- oh wait YES THEY DO!

there's no consistency in the law.

Just wondering if anyone has heard anything about this: I keep hearing about users getting awesome results by combining the "Put the Cookie Down HCL" with some new product called "LiftaweightaDrol". Supposedly a synergistic effect....... This could truly revolutionize the weight loss industry!

yea lanbane, but its too powerful and expensive for the casual dieter. Thats why its $200 for 60 caps of a breakthrough formula that is mostly caffeine!

If it also has Hoodia, put me down for 3 bottles.

Wow, I expected them to ban something for weight loss not make something else an over the counter placebo for couch potatoes who now think they have the green light to eat the same crap they still eat while hoping to lose 15 pounds of muscle hiding fat in 1 month.

I think the last fat blocking drug caused explosive diarrhea.

...but I love fat people. They make me look like I workout alot... Okay you can have the fat people but, I don't want to hear about any " smart " pills! You got that FDA! I am talkin' to you!

Originally Posted by cable626

yea but cigarettes, alcohol, ice cream and tylenol are sold over the counter without a learned intermediary, and people don't die from- oh wait YES THEY DO!

there's no consistency in the law.

Not sure about ice cream but maybe from a brain freeze?

And it's not about conistency.. it's about how much lobbyists, senators and other government officials are getting. I couldn't even begin to imagine how much cig, alchohol and big pharma are giving away to keep laws down.

I'm not sure how the pill works but I heard it blocks fat. if it blocks the good fats couldnt that be a problem also?
I bet the price is going to be pretty high. they were not making enough money from prescriptions.

yes.. they are saying in the reading that you must take a good multi and replenish your good fats with supps due to its ability to block any and all fat

It was approved today.

Our society is so sick. We eat more than we should, so our solution is to make a pill that inhibts the bodies ability to absorb the food.

WTF...so pathetic.

Whatever happened to natural selection?

Originally Posted by MaynardMeek

yes.. they are saying in the reading that you must take a good multi and replenish your good fats with supps due to its ability to block any and all fat

I wonder how they plan for people to replenish/supplement their "good fats" if they are taking something that blocks the absorption of fat.

who knows and dollars to donuts the people that would take this have no idea what the difference is between good/bad fats, they are just going to rationalize it by saying.. oooh i need to eat MORE fat.so lets down another supersized fries. yada yada yada

Originally Posted by JonesersRX7

Not sure about ice cream but maybe from a brain freeze?

a better one would've been McDonalds burgers...

"The primary concern of FDA reviewers was the drug's potential to create vitamin deficiencies, since its use also blocks absorption of fat-soluble vitamins like D, E, K and beta-carotene. The company has recommended patients take multivitamins when using the drug."

Total recipe for disaster IMO. Taking additional vitamins with a product that blocks their absorption amounts to a feel-good solution. Lowering Vit D in particular is just begging for several kinds of cancer. My prediction..colon cancer for many of the long term users given that their diets are probably crap to begin with.

it also says that you should only use for up to 6 months at a time, but once you get off the fat comes right back...so go figure...the pharmacy company is so damn corrupt..So basically, to keep the weight off, you have to NEVER stop using the stuff which goes against their own use recomendations... smh @ legalized drug pushers feeding us "fat crack" and saying the consumers should be able to govern themselves on its use. Its painfully transparent the goal is to hook you and keep you hooked.

you'll gain the fat back with any "diet" pill. the diet change and exercise is the only thing that will keep the weight off.