Posted on 01/24/2006 3:47:05 AM PST by AZRepublican
WASHINGTON (AP) -- 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 after 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.
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. Glaxo wants people to use the pill for only six months at a time, but as an over-the-counter item, its use could not be policed.
(Excerpt) Read more at cnn.com ...
Do think warning should warn. . .that the warnings themselves, prohibit litigation re product.
THAT said. . .refreshing to see the Government allowing people to be responsible for themselves. . .now we will see if they can while getting slimmer as well.
Sue for what? Losing too much weight?
"Sue for what? Losing too much weight?"
Nah. They'd probably sue because they were embarrassed when they had a BM in public. Uncontrolled BMs are some of the side effects as well as discharged gas. That could effect someone's "self-esteem" if they lost control in public. :)
Oh no. . .not for losing weight. . .of course not.
But rather, you know. ..for the too-hot coffee they drank to swallow the pill. . .or for the flu that followed when they started the pill. . .for the accident they had on the way to the store; having just digested the pill. WHATever it takes. . .someone will 'be there'.
I am just offering that might be a good ideas to include on the 'warning labels' of products. . .that you cannot sue the company.. .
For whatever side effects they experience regardless of whether they were using the drug consistent with its proper indications and directions.
Don't forget the incontinence. A little unctrollable whizzing does wonders for the self-esteem. Good thing they got ephedra off the market to clear the way for this stuff.
The side effects...
When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat -- the equivalent of about 150 to 200 calories -- 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.
Makes me reeealy want to take it!
Sue for what? Losing too much weight?
For needing to purchase new underwear frequently! Not just "tire tracks" but now "oil spots"!
bfl
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