FDA Considering OTC Sale of Fat Blocking Pill
 

FDA Considering OTC Sale of Fat Blocking Pill

By ANDREW BRIDGES, Associated Press Writer

Sun Jan 22, 6:21 AM ET

WASHINGTON - A pharmaceutical company that seeks federal approval for over-the-counter sales of a prescription diet pill that blocks the absorption of fat faces questions on the pill's potential for creating vitamin deficiencies and encouraging abuse.

Two Food and Drug Administration advisory committees are to discuss on Monday allowing over-the-counter sales of orlistat, which GlaxoSmithKline Consumer Healthcare proposes to market as Alli (pronounced "ally"). That version would be half the dose of the prescription form of the drug, known as Xenical, which won FDA approval in 1999.

An FDA reviewer found the drug is a "safe and effective weight loss agent," but held off on recommending whether the Nonprescription Drugs and the Endocrinologic and Metabolic Drugs advisory committees should in turn recommend to the FDA that it approve the drug for sale without a prescription.

The drug acts by blocking the absorption of about one-quarter the fat a patient consumes. That fat is then passed out of the body in stools, which can be loose or oily as a result.

In six-month clinical trials, obese subjects 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 released Friday.

FDA reviewer Dr. Karen Feibus said the primary concern with the drug is its potential to create vitamin deficiencies, since its use also would block absorption of fat-soluble vitamins like D, E, K and beta-carotene.

The company recommends patients take multivitamins when using the drug, said Steve Burton, GlaxoSmithKline's vice president of weight control. Whether that would happen remains unclear: at least 47 percent of the people involved in trials of the drug did not take multivitamins as recommended, the FDA said.

Orlistat may also block some drugs, including cyclosporine, used to prevent rejection of kidney, liver and heart transplants. Orlistat shouldn't be taken with that drug, the FDA said.

Furthermore, just 35 percent of diabetes patients in a study correctly stated the drug was not appropriate for them to use, according to agency documents.

The regulatory agency also is concerned about increased potential for abuse or misuse of the prescription-free version of the drug, especially among bulimics or binge-eaters who could develop vitamin deficiencies due to chronic use of the drug. There are at least four published reports of women suffering from bulimia using the prescription form of the drug as a purgative. An estimated 22 million people worldwide have used the drug.

"We believe there is a very low potential for misuse and abuse. But we need to be vigilant," Burton said.

The unpleasantness of the drug's side effects, including "involuntary leakage" of undigested fat, should limit its abuse, said Dr. Howard Eisenson, director of the Duke Diet and Fitness Center in Durham, N.C.

"I think to some extent, the side effects will limit the potential for abuse, because the side effects are uncomfortable or messy," said Eisenson, adding he has no financial ties to the drug or its manufacturer.

The company plans to limit sales of the drug to adults. It expects women to make up 80 percent of the expected market for the drug, which would cost consumers an estimated $12 to $25 a week.

The company intends to package Alli as part of an overall diet and fitness program. The program would emphasis eating a lower-fat diet, to both cut calories and curtail the drug's effect on a user's stools.

United Kingdom-based GlaxoSmithKline's U.S. operations are based in Philadelphia and Research Triangle Park, N.C.

The company declined to share sales projections, but said that 130 million Americans are overweight or obese and that consumers spend $23 billion each year on weight-loss strategies.


http://news.yahoo.com/s/ap/20060122...he_me/diet_pill

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Yup...that makes lots of sense to me. Here...take our drug that blocks fat absorption (along with a lot of fat soluble vitamins that you need to be healthy) and may give you diarrhea and oily leakage but to minimize that effect, eat a low fat diet which pretty much eliminates the need for the drug in the first place because now you don't have any fat calories to block... :daze:

The package directions should also include recommended cough and sneeze blockers .... :eek:


Doreen

Can you imagine working in an office with someone who has '"involuntary leakage" of undigested fat'?

Reminds me of Jeff Foxworthy's routine on drugs and their side effects!!!

Why was it only the tobacco companies got sued ???

IMHO the pharama companies have done much more damage ...

"The company recommends patients take multivitamins when using the drug, said Steve Burton, GlaxoSmithKline's vice president of weight control. Whether that would happen remains unclear: at least 47 percent of the people involved in trials of the drug did not take multivitamins as recommended, the FDA said."

How does it remain 'unclear' then? Obviously about half of the users (probably more it it's just OTC) would *not* take the supplements.

The potential for abuse of an OTC version of Xenical is just too great, IMO. This problematic drug should remain a controlled substance...

:-(

Is there long term studies that this actually assists in weight lose and helps you maintain your weight ?

Someone is making a buck out of human misery!

If you're walking around with "oily leakage" of undigested fat and diarrhea all the time, you'd think that at least you'd not have to eat a punishing low-fat diet to lose a little weight.

Isn't abuse of OTC pills like this practically a given??

If you take a starch blocker AND a fat blocker, can you eat everything in sight and still starve to death? How about adding a "metabolism booster" so you can starve to death even faster? OR if you've had your stomach stapled, you can live on very small quantities of tostitos, ice cream, and M&Ms consumed throughout the day.

I feel sick.

Reminds me of that drug alcoholic people can take that makes alcohol consumption a horrible experience and supposedly puts them off it.

This drug is less than useless. If it blocks only dietary fat, it doesn't do a damn thing about fat from de novo lipogenesis, so while your anus is leaking, you still have high triglycerides and lots of adipose tissue.

Dietary fat is the primary source of beneficial and essential fatty acids, while fat from de novo lipogenesis is primarily palmitate. So this drug would increase the proportion of palmitate in our bodies and suppress beneficial and essential fatty acids.

But is would make money for GlaxoSmithKline.

Looks like it's a done deal ... http://forum.lowcarber.org/showthread.php?t=282737


:rolleyes: