FDA Panel Recommends OTC Weight-Loss Pill

[leftchick]

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

WASHINGTON - Federal health advisers voted Monday to recommend over-the-counter sales of a weight-loss pill now sold only with a prescription.

GlaxoSmithKline Consumer Healthcare still needs final Food and Drug Administration approval before it can sell a nonprescription version of orlistat, a diet pill already marketed in prescription form as Xenical. The FDA approved the prescription version of the fat-blocking pill made by Roche in 1999.

A joint FDA advisory committee voted 11-3 to recommend approval late Monday following a daylong hearing. The agency usually follows the recommendations of its outside panels of experts, but its final decision could take months. If approved, orlistat would be the first weight-loss drug sanctioned for over-the-counter sales. Roche will continue selling Xenical regardless.

"We are excited about the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss," said George Quesnelle, president of GlaxoSmithKline Consumer Healthcare North America.

[Warpy]

1. What this pill does is block about a third of dietary

fat from being absorbed from the gut. If you eat a very high fat diet, you'll get the best results in terms of reducing your calories. However, you'll also get the worst side effect, which is copious diarrhea. The lower fat the diet, the less diarrhea one has as a side effect, and I suspect this is what causes the weight to come off. If you know those globs of butter slathered all over everything are going to make you sprint for the bathroom in about 6 hours, you tend to reduce or eliminate them.

Remember Olestra? The side effect from eating a high fat diet and taking Xenical would be quite similar to the side effect of eating a whole bag of Olestra chips.

[leftchick]

2. That is exactly what I thought when I read this

Olestra! yum! :puke:

[Cobalt Violet]

3. Maybe I should buy some Depends stock.

:smoke: :smoke: :think: :smoke: :smoke:

[Heddi]

5. I wonder how much havock that will wreck on people's Electrolyte balances?

I mean, you lose alot of potassium with constant diarrhea---which will no doubt occur in people who think they can take the "skinny pill" but still eat 3 Big Mac's a day, etc.

When Olestra came out however many years ago, I had gotten a bag of olestra potato chips. Afterwards, hillarity ensued and I vowed never to eat anything that contained that evil ingredient again. Thankfully, I'm quick on my feet and made it to the toilet without incidence. My mother wasn't so lucky and what she thought was simple flatulence turned into quite a mess. Luckily she was home at the time...luckily.

So would people who use these pills be at a higher risk of hypokalemia and the associated cardiac arrhythmias associated with them? Right now, since the pill is by Rx only, I'd assume that people at high risk (that have pre-existing arrhythmias, etc) would be counceled and closely monitored with blood tests...but if this is OTC, will we see alot more adverse reactions than necessary? Of course there's warning labels on the bottle, but that doesn't mean that people will read them. And it's very likely that there are alot of people out there with arrhythmias that don't know it because they haven't been diagnosed with them. And I think it's safe to say that 90% of the population wouldn't know what hypokalemia was if you paid them $25 to tell you. Nor would they know which foods are high in potassium so that they could supplement their diet with such.

Bet you'd see ALOT of dehydration as well.

I see this being pulled off the market quickly after being put on. I think there's going to be alot of health problems because people aren't taking it properly and creating problems they've never had, or ascerbating ones that they do....

[leesa]

4. If the FDA is pushing it, I would advise against it.

Somebody has some payola involved.

[alarimer]

6. And yet they refuse to allow Plan B to be sold OTC

guess which makes more money for drug companies? A diet pill since so many people are desperate to lose weight they will try anything.

[DesertRat]

7. The over the counter Xenical will be

a low-dose version of the original. The company plans to market under the name "Alli".