FDA wants to sell Rx diet pill OTC

[cardaway]

I don't see anything to get excited over. Personally, I do not like to take pills, prescription or OTC, I hate putting unnatural things in my body. But if someone thinks it will help them or give them the motiviation for a healthier lifestyle, then I am all for it.

I'm in the same boat, except when it comes to allergy meds. Come this spring I think I'm going to be wishing the really effective meds were OTC, and that's why I'm interested in this scenario despite the fact it's something I will never take.

 

[Rafiki Rafiki Rafiki]

I have mixed opinions about this issue.

I've taken drug classes and am aware of the whole FDA approval process and the issues surrounding medication use/misuse.

When I first heard word of this possible OTC approval, I thought the FDA would never go for it. I agree with the possible misuse issues and lack of care on other issues, Steve.

However, I also believe that a good number of people who are obese to grossly-obese are not seeing doctors on any issues, period because they don't want to deal with the embarrasment of obesity. These people could potentially merit from the use of such a pill.

Let's face it. People are going to do what they want to do in the end. If they care about losing weight and managing their lifestyles, they'll visit their doctor for at least a consultation.

There are people who the opposite of this is true. I am obese and have visited my doctor about this issue. He will not prescribe any weight-loss medications, period...and it's not because I don't have enough weight to lose...and it's not because my blood pressure is too high. It's because he doesn't BELIEVE in weight-loss medications.

I've found that to be the case with every one of the doctors I've visited in the past three years at two different military bases. I think the drug company that is pushing for OTC approval is in touch with the notion of doctors who refuse to prescribe these types of medications.

In the end, I think we'll have to see what happens. There were a lot of people who opposed moving medications such as Pepcid to OTC status, but I have to believe that people are much better off with this drug's wide availability. Maybe we'll get to that point with Xenical too.

 

[JVL1018]

Have ya tried the Herr's Chocolate Covered Chips, yet?

I actually tried ONE at a Christmas party and I thought that it was NASTY.

I have never even seen them! I love chocolate covered pretzels, so I might like it!

 

[lsyorke]

Here is the report of the FDA advisory committee on this drug.

http://www.fdaadvisorycommittee.com...lic+Drugs/012306_Orlistat/012306_XenicalP.htm

Doesn't sound all that positive to me.

Hmmm, I wonder how they'll handle "anal seepage" and "oily discharge" in the commericials???

 

[disneysteve]

Come this spring I think I'm going to be wishing the really effective meds were OTC.

When Claritin went OTC a few years ago, here's what happened.

1. Patients who were already on Claritin and doing well were forced to either start buying it (pretty expensive) or switch to another drug that may or may not have worked as well for them.

2. Many insurance companies stopped paying for Allegra and Zyrtec, the 2 other non-sedating prescription antihistamines.

So the Claritin patients were negatively affected, and the non-Claritin patients were also negatively affected. The only people who benefited were folks without insurance who could then get Claritin without seeing a doctor. As a doctor, I was forced to either recommend OTC Claritin (which was often unaffordable for many of my patients) or prescribe an older medication that was covered but not as safe or effective.

The situation has gotten a little better over time because there are now less costly generic versions of Claritin, but for many of my patients, that still isn't an option as I work in a very poor area. So putting Claritin OTC impacted my ability to treat patients in the safest way possible. I've got a problem with that.

 

[golfgal]

Actually, the advisory panel addressed this. They felt that those with eating disorders wouldn't be likely to abuse this med because it doesn't result in quick weight loss. Without that instant gratification, they didn't feel folks would abuse it.

Does this advisory panel live in the real world? I am sure that the 12 year old girl in DS's class that started having MAJOR anorexia problems last year is up to date on how all the medications she is taking to help her lose weight so she can go from 70 pounds down to 60 pounds is going to effect her. .


As for TELLING patients anything, THEY DON'T LISTEN! They hear what they want to hear and then do what ever the heck they think anyway. Then you have to deal with the dumb ones like the lady that had her baby in our dr's office because her eyes were all red, turns out she was putting the Tylenol Infant drops in the babies eyes because the thing was an eye dropper, wasn't it?

Then there was the couple that had their child in because her ear infection wasn't getting better, well you have to have them SWOLLOW the medicine not put it in their EAR!

You really think people read directions????? Can you IMAGINE the lawsuits?

CathrynRose, I totally understand the inhaler thing, but you are a responsible adult. I think of all the kids in middle school who would think it was COOL to take an inhaler and heck, it can't hurt you because you buy it over the counter, it isn't like it is a prescription or anything, right?

Everyone has to remember that there really are DUMB people in this world and that is why a lot of things have warnings on them that are just laughable (like curling irons that warn you not to use them while bathing or sleeping).

 

[wvjules]

Does this advisory panel live in the real world? I am sure that the 12 year old girl in DS's class that started having MAJOR anorexia problems last year is up to date on how all the medications she is taking to help her lose weight so she can go from 70 pounds down to 60 pounds is going to effect her. .


As for TELLING patients anything, THEY DON'T LISTEN! They hear what they want to hear and then do what ever the heck they think anyway. Then you have to deal with the dumb ones like the lady that had her baby in our dr's office because her eyes were all red, turns out she was putting the Tylenol Infant drops in the babies eyes because the thing was an eye dropper, wasn't it?

Then there was the couple that had their child in because her ear infection wasn't getting better, well you have to have them SWOLLOW the medicine not put it in their EAR!

You really think people read directions????? Can you IMAGINE the lawsuits?

CathrynRose, I totally understand the inhaler thing, but you are a responsible adult. I think of all the kids in middle school who would think it was COOL to take an inhaler and heck, it can't hurt you because you buy it over the counter, it isn't like it is a prescription or anything, right?

Everyone has to remember that there really are DUMB people in this world and that is why a lot of things have warnings on them that are just laughable (like curling irons that warn you not to use them while bathing or sleeping).

What does this have to do with Xenical being OTC? There are goign to be people that abuse medications whether they are prescription or OTC. As for the stupid people...you'll have those either way too.

 

[Rafiki Rafiki Rafiki]

When Claritin went OTC a few years ago, here's what happened.

1. Patients who were already on Claritin and doing well were forced to either start buying it (pretty expensive) or switch to another drug that may or may not have worked as well for them.

2. Many insurance companies stopped paying for Allegra and Zyrtec, the 2 other non-sedating prescription antihistamines.

So the Claritin patients were negatively affected, and the non-Claritin patients were also negatively affected. The only people who benefited were folks without insurance who could then get Claritin without seeing a doctor. As a doctor, I was forced to either recommend OTC Claritin (which was often unaffordable for many of my patients) or prescribe an older medication that was covered but not as safe or effective.

The situation has gotten a little better over time because there are now less costly generic versions of Claritin, but for many of my patients, that still isn't an option as I work in a very poor area. So putting Claritin OTC impacted my ability to treat patients in the safest way possible. I've got a problem with that.

Within one year of Claritin hitting the market as an OTC drug, the price dropped from $2 a pill to $1 a pill. I think its switch relieved a huge and unnecessary burden on our healthcare system.

I don't feel like the money argument is a valid one for this fat-blocker...because if it is offered OTC, nearly any cost for the drug is smaller than the cost of morbid obesity.

 

[kpm76]

When Claritin went OTC a few years ago, here's what happened.

1. Patients who were already on Claritin and doing well were forced to either start buying it (pretty expensive) or switch to another drug that may or may not have worked as well for them.

2. Many insurance companies stopped paying for Allegra and Zyrtec, the 2 other non-sedating prescription antihistamines.

So the Claritin patients were negatively affected, and the non-Claritin patients were also negatively affected. The only people who benefited were folks without insurance who could then get Claritin without seeing a doctor. As a doctor, I was forced to either recommend OTC Claritin (which was often unaffordable for many of my patients) or prescribe an older medication that was covered but not as safe or effective.

The situation has gotten a little better over time because there are now less costly generic versions of Claritin, but for many of my patients, that still isn't an option as I work in a very poor area. So putting Claritin OTC impacted my ability to treat patients in the safest way possible. I've got a problem with that.

Yup. Claritin went from costing me about 16 cents per day to about a dollar per day....making it OTC didn't really help anyone as you pointed out...I'd much rather pay $10 to see my allergist once per year and get a prescription for the entire year than to have to pay for it OTC.....DH and I are very lucky to have great health insurance and we are very grateful for it. It's much better for us to pay the co-pay to see the Dr. and get the prescription than to pay OTC....more economical if you want to look at it that way.

 

[caitycaity]

Everyone has to remember that there really are DUMB people in this world and that is why a lot of things have warnings on them that are just laughable (like curling irons that warn you not to use them while bathing or sleeping).

darwinism.

 

[disneysteve]

I don't feel like the money argument is a valid one for this fat-blocker...because if it is offered OTC, nearly any cost for the drug is smaller than the cost of morbid obesity.

I'm not exactly sure what you're saying here.
The cost of morbid obesity includes the cost of treating all the associated conditions I mentioned earlier - blood pressure, diabetes, cholesterol, arthritis. So just taking the Xenical and ignoring all the related problems will not reduce costs to the system. In fact, it will increase costs because those problems will be left untreated longer and patients will suffer more complications. So if you want to look at the long term cost effectiveness, it is better to have the patient under the care of a physician.

 

[Toby'sFriend]

Everyone has to remember that there really are DUMB people in this world and that is why a lot of things have warnings on them that are just laughable (like curling irons that warn you not to use them while bathing or sleeping).

So should we take those off the market shelves too --- maybe require permission from a liscensed beautician before you are allowed to style your own hair?

 

[poohandwendy]

maybe require permission from a liscensed beautician before you are allowed to style your own hair?
__________________

LOL, I work in a salon and we would definitely vote that many women should required to gain permission before being allowed to style their hair....but that is another debate altogether...

 

[golfgal]

What does this have to do with Xenical being OTC? There are goign to be people that abuse medications whether they are prescription or OTC. As for the stupid people...you'll have those either way too.

The point is that it will give access to anorexics and other people with eating disorders if Xenical goes over the counter. No doctor would ever give a prescription to an anorexic for Xenical.

 

[poohandwendy]

The point is that it will give access to anorexics and other people with eating disorders if Xenical goes over the counter. No doctor would ever give a prescription to an anorexic for Xenical.

People with eating disorders abuse OTC laxatives already, I really don't see the difference. I don't really see that as a compelling argument.

 

[golfgal]

People with eating disorders abuse OTC laxatives already, I really don't see the difference. I don't really see that as a compelling argument.

The argument is that it gives them one more thing to abuse I guess. While using the laxatives will help you temporarily lose some water weight, it isn't a "permanent" think like a pill designed for weight loss.

I still would like to know what kind of studies have been done on the long term effects of this drug. Like I said in an earlier post, there have been some MAJOR side effects with other weight loss pills and do we really want something that is potentially lethal available over the counter before such studies are done?

 

[poohandwendy]

The argument is that it gives them one more thing to abuse I guess. While using the laxatives will help you temporarily lose some water weight, it isn't a "permanent" think like a pill designed for weight loss.

Actually, from the description, I think it would have a very similar effect as laxatives. Maybe Steve could comment on that. And people with eating disorders who use laxatives, use them regularly, so it does have long term effects on their health (absorption).

I still would like to know what kind of studies have been done on the long term effects of this drug. Like I said in an earlier post, there have been some MAJOR side effects with other weight loss pills and do we really want something that is potentially lethal available over the counter before such studies are done?

Not sure how long this drug has been around, but it had to pass FDA regulations to be offered by prescription in this country.

 

[disneysteve]

it had to pass FDA regulations to be offered by prescription in this country.

Hismanal, Seldane, Rezulin, Pondimin, Baycol, Vioxx, Bextra... These all passed FDA regulations to be offered by prescription in this country. All have since been withdrawn from the market due to safety issues that did not come to light until after they were on the market for quite a few years.

 

[poohandwendy]

Hismanal, Seldane, Rezulin, Pondimin, Baycol, Vioxx, Bextra... These all passed FDA regulations to be offered by prescription in this country. All have since been withdrawn from the market due to safety issues that did not come to light until after they were on the market for quite a few years.

True, but that can happen with any drug. How long should a drug be in trial periods before passing regulations? Pick a number and there will a drug that shows safety issues after that time frame. No, it is not a perfect system.

 

[Apothecary]

As far as "diet pills" go, this one is by far the safest one. No real systemic (or internal) actions. It , as others have said, blocks fats from being absorbed. Very safe, effective for some. I am not a big fan of drugs moving from Rx to OTC status, but this is one that, in my opinion as a pharmacist, is ok.