Thursday, February 08, 2007

FDA No Weight Loss 'Alli' Approving OTC Drug

An OTC version of the weight loss drug orlistat gets FDA-approval

It wasn't a matter of if, but when.

This Washington Post story details the disappointing news that the United States government regulatory agency over approving medicines that can be sold without a prescription in this country has given its final blessing to an over-the-counter version of a prescription weight loss drug made by pharmaceutical company GlaxoSmithKline, who calls this "the only FDA-approved weight loss product available to consumers without a prescription." Yippee freakin' skippy!

You may recall last January when I blogged about the weight loss drug orlistat following an 11-2 recommendation by a group of medical "experts" who deliberated for all of one whole day about whether the risky prescription medicine Xenical should be made available in an OTC formula.

Today, the Food & Drug Adminstration (FDA) made it official and gave the rubber stamp to sell orlistat using the name "Alli." No, it's not pronounced like Muhammed Ali (AH-LEE), but rather like the word "ally" (AL-EYE) as in someone who is on your side.

The irony in that name is that the FDA is certainly no "Alli" to anyone desiring weight loss with their outlandish and irresponsible approval of this drug. They really ought to be ashamed of themselves for putting a drug like this one out there because obesity pills are just pie in the sky promises that don't deliver without a little effort on the part of the dieter. And the FDA even acknowledges that fact.

While they don't encourage children under the age of 18 take this drug (but who are we kidding? Parents will be buying this drug for their fat kids left and right!), it is absolutely open game for adults willing to combine it with a low-fat, low-calorie, portion control diet and exercise program. That's right, just in case you missed the fine print from the FDA about this latest cure-all for obesity, the dirty little secret is you STILL have to diet!

Don't even think about livin' la vida low-carb while taking the 60 mg capsules of "Alli" right before each of your three daily meals either because it only works well in people who eat little to no fat in their diet. Yep, not only do you get the unique pleasure of having most of the fat you put inside of your body sucked completely dry like a shallow river basin in 110 degree heat, but you also are FORCED to eat a low-fat diet in the process to make it work. Aren't you just so very happy about that?!

But wait, there's more!

In addition to not absorbing dietary fat (which can be dangerous on a number of levels that you don't even want me to get into!), this drug may very well prevent you from absorbing some of the most essential nutrients in the foods you eat. Therefore, they recommend you take a multivitamin before you go nighty-night sucking your thumb while holding a fuzzy wuzzy teddy bear.

Isn't this hilarious? While opponents of livin' la vida low-carb always chastise us for promoting vitamin supplementation on our very natural and healthy way of eating, here's the FDA telling people they need to eat a low-fat diet and take supplements if they decide to start using the "Alli" OTC weight loss pill. And this is the WEAK version of the drug Xenical--can you imagine what the full-strength one is like?

Like most drugs, "Alli" is not without some really nasty side effects. Try this on for size: loose stools, excess gas, fatty stools, possible uncontrollable bowel movements, flatulence with discharge, abdominal pain, and a general sense of poop-poopy-doop 24 hours a day, 7 days a week, non-stop fun between you and the porcelain goddess! Aren't you so glad you chose to lose weight this way? NOT! Sounds about as bad as the weight loss drug for dogs I blogged about last month!

Seriously, though, orlistat is NOT for everyone (I don't think it's for ANYONE, but that's just my take on it!). People who have had an organ transplant shouldn't take it because of drug interactions and neither should people on blood thinners, who are diabetic, have a thyroid problem, binge eating disorder, bulimia nervosa, or malabsorption syndromes. The FDA says people with these conditions should consult with their before using this over-the-counter drug.

Um, maybe I'm thinking too hard about this, but why make a drug OTC if there are very real dangers to a large segment of the population with all those ailments listed above? Has the FDA completely gone out of its mind here (don't answer that question because we already know the answer)?!

I'm telling you, this is a class action lawsuit just waiting to happen. The FDA has no idea what it has gotten itself into approving a drug like orlistat and making it available to anyone and everyone walking through the grocery store, Wal-mart, or drugstore. The end result will be more obesity and a lot more tummy aches.

I've said it before, but I'll say it again and again if I have to. People need to stop looking for the next great diet pill to come prancing in like Prince Charming to swoop them off their feet with promises of weight loss nirvana. Sorry to burst your fantasy everyone but it ain't gonna happen...nor should it!

Weight loss can be achieved safely and naturally without the use of ANY drugs whatsoever. Not once during my nearly 200-pound low-carb weight loss experience over these past few years have I felt compelled to add a drug, prescription or otherwise, to my diet for the purposes of aiding in my weight loss. NEVER! If I didn't trust my low-carb lifestyle to do everything I needed it to to shed the pounds and restore my health, then I'd start looking for another way to eat.

It should be quite disturbing to anyone who is eating a low-fat, low-calorie diet right now that their diet all by itself just isn't good enough to bring about weight loss and improved health. Nope, they have to have something like orlistat to be added to them in order for them to work better (although the jury is still waaaaay out on that claim!). Why put yourself through all of that?!

Come on over to livin' la vida low-carb and enjoy what REAL healthy living is like. No drugs, no forced diet plans, no disgusting foods to put up with--just delicious foods that help produce amazing positive results in your weight and health.

Why would you choose any other way?

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Blogger Science4u1959 said...

This is just another outrage! It hurts me to say this, but America is another step closer to total degeneration. It is things like this make me want to weep! And I am not even an American!

Although I do not consider myself a conspiracy buff, it IS a fact that these days we have to be aware of the very real dangers our respective Governments pose. People these days are afraid of Gov't... and often rightly so.

One of your famous Presidents, Abraham Lincoln, observed: "People should not be afraid of their Government. Government should be afraid of the people".

If only America would have true leaders like him in Government again...

2/09/2007 12:03 AM  
Blogger Diamondwife said...

I will never understand the FDA.
In the 80's my uncle invented a "sensor pad". What it was at the time was basically 2 pieces of latex with a slippery substance between it. He demonstrated it by putting a grain of salt on the table and with this device it felt like a small pebble. Its purpose was to help women find lumps sooner in breast self-exams. It eventually did get approved and they sold the idea and a company is marketing it, but that took over 10 years. Yes, 10 years, for a totally non-invasive item that could have helped save tons of women from breast cancer. (On a side note, they also made a larger version to be used in helping transfer patients and it is being used in hospitals today). Why does the FDA approve obviously dangerous medications but take 10 years to approve a simple non-invasive device.

2/09/2007 7:43 AM  
Blogger Big Daddy D said...

Several years ago, I took orlistat for a couple of weeks. If you are not already on a super low fat diet, it makes life very unconfortable. The label warns of diarriah. Well, it's a bit misleading. It's more like foul smelling vegitable oil coming out of your back end. It's so liquid and oily that it's difficult to hold in and resulted in more than one "accident" during my two week trial. I don't recall having lost any weight. Even if I did, it wouldn't have been worth it. I am currently doing a low-carb diet with no diet pills. I've lost almost 70 pounds in six months. I'd imagine that since my diet is now a little higher in fat than before that if I were to add orlistat, I'd be unable to leave my bathroom. Check out my blog:

2/09/2007 1:39 PM  
Blogger healthgeek said...

Thanks for the eye opener Jimmy!

This subject is close to the heart...

2/10/2007 7:59 AM  
Blogger Scott K said...

Dr. Michael Eades posted something about this on his blog as well. This is going to be the miracle pill that everyone has been waiting for....well, until the next miracle pill.

2/12/2007 12:14 PM  
Blogger tinyorangepig said...

Maybe I am naive, but the manufacturer's website, , says that the side effects are preventable if you stick to a low calorie, reduced fat diet. So if you did that you would lose weight, but this will help with a few more pounds. Maybe it is not worth the $$, but just the plan might help people live healthier lives, which is good, right?

2/15/2007 5:26 PM  
Blogger Jimmy Moore said...

THANKS for your comments, tinyorangepig, but I think you are missing my primary point. The fact that you MUST eat a low-calorie, low-fat diet WHILE taking this drug is absurd.

Eating that way has been shown in studies to be very ineffective for weight loss and is not as "healthy" for you as we have been led to believe. I've blogged about that quite often here.

But anyone who wants to eat a low-carb diet, which is higher in fat and calories than what they are suggesting people do with this pill, will have MAJOR problems with Alli.

Why not just get on the low-carb lifestyle and stay there to see lasting weight control while enjoying healthy and great-tasting foods in the process?

2/15/2007 5:32 PM  
Blogger Lori said...

Jimmy, Jimmy, Jimmy...c'mon you KNOW it's cuz the toilet paper industry is experiencing a lag since wet wipes have come around...

1/03/2008 3:59 PM  

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