Results 1 to 8 of 8

Thread: Prescrip. Fat Blocker to be sold over the counter

  1. #1
    Veteran Member TarynJolie's Avatar
    Joined
    Oct 2005
    Posts
    572
    Thanks
    0
    Thanked 0 Times in 0 Posts

    Default Prescrip. Fat Blocker to be sold over the counter

    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 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.

    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 it for only six months at a time, but as an over-the-counter item, its use would not be policed.

    The pill's effect ends once its use is stopped, said Dr. Julie Golden, a medical officer in the FDA's division of metabolism and endocrinology products. A previous study showed a progressive weight gain in patients after they discontinued use of orlistat, she said. Quesnelle said people could resume use or seek help from a doctor if they gain weight.

    "I think the drug is safe enough to be OTC. It's an OTC indication. Although there are some i's that need to be dotted and t's crossed, it's suitable for OTC use," panel chairman Dr. Alastair Wood said following the vote.

    The panel requested that the company conduct follow-up studies if and when the drug does reach the market, as well as rework the pill's label to ensure its proper use, Wood said.

    Glaxo said the drug helps the overweight slim down only when combined with a diet and exercise regimen. The drug's actual effect on weight loss is "gradual and modest," said Steve Burton, Glaxo's vice president of weight control.

    "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.

    Dr. Sidney Wolfe of the watchdog group Public Citizen urged the panel to reject the company's application, calling it a "desperate attempt to revive this barely effective drug by an OTC switch."

    Deborah Fisher, a nurse from the Baltimore area, told the panel: "We need this new solution to losing weight and keeping it off."

    "Eat less, move more: It sounds pretty simple, doesn't it? Well, as my kids say, not!" said Fisher, adding that she's dieted for 45 of her 52 years.

    The proposed over-the-counter orlistat pill, called Alli (pronounced "ally"), would contain half the dose of the prescription capsule.

    Alli could cost consumers $12 to $25 a week, Glaxo said. The company estimated 5 million to 6 million Americans a year would buy the drug if offered over the counter. Those numbers could mean at least $1.5 billion a year in retail sales.

    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. Half of the patients enrolled in trials of the drug failed to understand labeling directions that they should take supplemental vitamins at least two hours before or after using the pills.

    The drug also could cause problems for organ transplant patients taking the drug cyclosporine as well as those on warfarin, a blood thinner. The drug's label would warn such patients against taking the weight-loss pill.

    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.

    Furthermore, just 35 percent of diabetes patients in a study correctly stated that the drug was inappropriate for them, according to FDA documents.

    Those 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 expressed 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, with only four published reports of bulimics using the drug. More than 22 million people worldwide have used orlistat in prescription form.

  2. #2
    Member
    Joined
    Oct 2004
    Location
    San Francisco
    Posts
    38
    Thanks
    0
    Thanked 0 Times in 0 Posts

    Default Re: Prescrip. Fat Blocker to be sold over the counter

    yea i saw that on the news but the dose would be 1/2 of what is/was prescribed from the doctor so would it still be effective? and would you girls take it if it is approved to be OTC?
    live your life to the fullest.. as if you have no tomorrow

  3. #3
    Yekhefah
    Guest

    Default Re: Prescrip. Fat Blocker to be sold over the counter

    The most common side effect, apparently, is "involuntary rectal leakage." No, thank you.

    Since your body isn't absorbing all the fat from your diet, the fat passes through in your waste, making it oily and greasy. And I'm not sure that being a few pounds lighter would be sexy enough to compensate for having oily waste dripping from your behind.

  4. #4
    Senior Member jadenphilly's Avatar
    Joined
    Jan 2005
    Location
    Philly
    Posts
    82
    Thanks
    0
    Thanked 0 Times in 0 Posts

    Default Re: Prescrip. Fat Blocker to be sold over the counter

    OMG that is nasty. Nope don't think that I would take it.

  5. #5
    God/dess
    Joined
    Nov 2004
    Posts
    2,352
    Thanks
    0
    Thanked 0 Times in 0 Posts

    Default Re: Prescrip. Fat Blocker to be sold over the counter

    I may give it whirl not everyone is affected the same just got to control the urge to rip one off real loud or do it with one eye closed lol ..And carry an extra pair of drawers . What's that smell ? Well honey I just lost a pound and its really warm and wet ewwwww !

  6. #6
    Featured Member Meea's Avatar
    Joined
    May 2004
    Posts
    872
    Thanks
    2
    Thanked 12 Times in 8 Posts

    Default Re: Prescrip. Fat Blocker to be sold over the counter

    LOL CuriousJ!

    i think that's why olestra chips aren't popular anymore - involuntary anal leakage

    hahaha

  7. #7
    God/dess FrustratedBunny's Avatar
    Joined
    Jan 2006
    Location
    New Orleans, LA
    Posts
    2,457
    Thanks
    0
    Thanked 4 Times in 4 Posts

    Default Re: Prescrip. Fat Blocker to be sold over the counter

    screw that. I'd rather be 300 lbs than shitting myself!

  8. #8
    Featured Member Lola Lee's Avatar
    Joined
    Sep 2005
    Location
    Plastic & Powder, Arizona
    Posts
    946
    Thanks
    0
    Thanked 5 Times in 5 Posts

    Default Re: Prescrip. Fat Blocker to be sold over the counter

    You don't really shit yourself from taking Xenical. It's more like meatloaf grease that can come out if you eat a REALLY high fat meal. LOL! It proves that it works though.

    I am a recovered diet pill junkie. I used to order it online from New Zealand all the time for about a $100 bucks a box. I would just say that I was 5'2" tall and weighed 200 lbs. And an online doctor would "approve" my prescription and send it to me. Never had any problems with customs.

    I am curious if it will be as expensive being sold OTC.

    I don't think this is a good thing (being sold OTC) for people for various reasons. People with eating disorders will flock to buy this product. I got so obsessive compulsive with it I started taking it for any food that could possibly have more than 10 grams of fat in it which is basically equivalent to a slice of cheese or a teaspoon of peanut butter. And although the directions say to take only one, I would take several if I did eat something fattening like pizza or enchiladas.

    It also worries me that younger people and teens will get a hold of it thinking it is their solution to staying thin instead of learning to eat healthy and indulge in moderation.

    I am sure I'll go into Walgreen's someday and see a box and struggle with the decision to buy it or not. But I've been diet pill sober for about 2 years now. YaY. One day at a time! LOL!




    "Go Confidently in the Direction of Your Dreams...Live the Life You Have Imagined" -- Henry David Thoreau

    "You Will Be Successful in Business and Married Life" -- Fortune Cookie

Similar Threads

  1. Carb-blocker pills
    By Bella21 in forum Body Business
    Replies: 9
    Last Post: 07-14-2008, 04:14 PM
  2. Plan B Available over the counter!
    By VegasPrincess in forum Body Business
    Replies: 11
    Last Post: 08-03-2007, 08:39 PM
  3. Fox Blocker.
    By onlythebest in forum Political Poo
    Replies: 2
    Last Post: 03-29-2005, 07:11 AM
  4. Pictures from the Counter-Inauguration
    By Djoser in forum Political Poo
    Replies: 6
    Last Post: 01-21-2005, 04:26 PM
  5. Counter-Inauguration
    By Djoser in forum Political Poo
    Replies: 41
    Last Post: 01-20-2005, 06:05 AM

Bookmarks

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •